Regenerativní medicína 2014 - Národní Centrum Tkání a Buněk as

Transkript

Mezinárodní konference
Regenerativní medicína 2014
2014 International Regenerative
Medicine Conference
April 9 – 10, 2014, Brno
Hotel Holiday Inn
Operační sály BLOCK ® Surgical
Komplexní dodávka operačních sálů na klíč:
konzultace, projekční činnost, vestavba s technologií a vybavením, servis.
K výstavbě operačních a zákrokových sálů společnost BLOCK® vyvinula a neustále inovuje
vlastní, moderní systém Surgical, připravený pro technologie budoucnosti.
Hlavní výhody:
• Atraktivní horizontální členění
• Barevná, materiálová a konstrukční proměnlivost
• Jednoduchá odnímatelnost panelů
• Dodatečná integrovatelnost technologií
• BLOCK® je přímý výrobce systému Surgical
• Vynikající poměr cena / výkon
• Rychlost instalace
• Antibakteriální povrchová úprava
• Možnost desinfikovat parami H2O2
• Systém odpovídá vysokým nárokům
na hygienickou nezávadnost, snadnou
čistitelnost a desinfikovatelnost
Sídlo firmy: BLOCK a.s., Stulíková 1392, 198 00 Praha 9 Korespondenční adresa: BLOCK a.s., U kasáren 727, 757 01 Valašské Meziříčí
Tel.: +420 571 670 111 Fax: +420 571 670 244 E-mail: [email protected]
w w w. bl o ck . c z
Národní Centrum Tkání a Buněk
National Cell and Tissue Centre
&
4MEDi – Centrum buněčné terapie a diagnostiky
4MEDi – Centre for Cell Therapy and Diagnostics
are organizing
2014 INTERNATIONAL REGENERATIVE
MEDICINE CONFERENCE
under the auspices of
the Minister of Health of the Czech Republic
&
the Mayor of the statutory city of Brno
April 9 –10, 2014, Hotel Holiday Inn
Brno, Czech Republic
General Partner
Dear Colleagues
It is with great pleasure to welcome you on behalf of the Organizing committee, the National Cell and Tissue Centre,
the company 4MEDi and the collaborating partners to the 2014 International Regenerative Medicine Conference in
Brno auspiced by the Czech Ministry of Healthcare and the Mayor of the statutory city of Brno. We are delighted to
welcome all participating delegates to this excellent event.
I trust that you are looking forward to hear two days of stimulating lectures and to have the opportunity of networking and to find new colleagues in the field of regenerative medicine. We have an excellent group of speakers
covering the up-to-date hot topics, enthusiastic and keen to share their knowledge with you.
We are very honored to be holding the Conference of rapidly developing field of medicine with a leading international representation for the first time in the Czech Republic.
Thanks to a number of leading Czech medical institutions and important biotechnology companies, Czech Republic
starts to be considered as a country where regenerative medicine is witnessing its explosive growth.
The Conference will provide you with a very exciting programme of the up-to-date information and knowledge to
enhance your own specialty areas of work. Take the opportunity to discuss with your colleagues, friends, partners
and mentors. You will witness how long-term commitment and hard work has resulted in solid approaches with
the acceptance in regenerative medicine. As you will see the international collaborations are expanding across the
continents, as it is necessary to harmonize approaches, methods and regulation globally.
Many thanks to the Organizing team of the Conference and the event supporting partners. We would not be able
to run the Conference without their kind support and to bring inspired people together.
I would like to thank each of you for attending our Conference and bringing your fruitful expertise to our gathering.
The international collaboration within the field of regenerative medicine is very essential for successful development.
You, as the main leading persons, have the vision, the knowledge and the experience to help us pave our way into
the regenerative medicine future.
I trust that you will return from the Conference inspired by excellent lectures and that you will have made new
contacts that will support you in your essential work.
I hope the Conference will fulfill your expectations and will allow you to actively contribute to the research and
development in the field of tissue engineering and cell therapy in regenerative medicine.
It is my pleasure to wish you all a successful Conference.
Václav Procházka
Chair of the Conference
Vědecký výbor Konference
Conference Scientific Committee
MUDr. Václav Procházka, Ph.D. – předseda výboru / chair of the committee
Fakultní nemocnice Ostrava
University Hospital Ostrava
Prof. MUDr. Petr Arenberger, DrSc., MBA
Fakultní nemocnice Královské Vinohrady
University Hospital Royal Vineyards, Prague
Prof. MUDr. Roman Hájek, CSc.
Prof. MUDr. Martin Krbec, CSc.
RNDr. Eva Matějková
Národní Centrum Tkání a Buněk a.s.
Odborní partneři konference
Conference Scientific Partners
Fakultní nemocnice Brno
University Hospital Brno
Nemocnice Na Bulovce
Hospital na Bulovce
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Hlavní témata Konference
Conference Main Topics
1. Výzkum a vývoj Regenerativní medicíny
2. Současný vývoj v preklinických a klinických studiích
3. Současné světové trendy a výsledky oboru
Regenerativní medicíny
4. Legislativní zázemí, regulace a etické otázky
5. Vývoj Regenerativní medicíny v České republice
6. Klinické využití Regenerativní medicíny
7. Buněčná terapie
8. Tkáňové inženýrství
9. Tkáňové transplantáty
1. Regenerative Medicine Research and Development
2. Current Development in Pre-Clinical and Clinical Studies
3. Current Global Trends and Results of Regenerative Medicine
4. Legislative environment, Regulations and Ethical Issues
5. Potential of Regenerative medicine in the Czech Republic
6. Clinical Use of Regenerative Medicine
7. Cell Therapy
8. Tissue Engineering
9. Tissue Transplants
Organizační výbor konference
Organizing Committee
Ing. Petr Koška, MBA
MUDr. Dagmar Hrůzová
PrimeCell Therapeutics a.s.
Ing. Jakub Schůrek, MBA
Andrea Gutová, M.A.
Vzdělávací akce je pořádána dle Stavovského předpisu ČLK č.16.
Vzdělávací akce je pořádána podle vyhlášky MZČR č. 4/2010 Sb., kterou se stanoví kreditní systém
pro vydání osvědčení k výkonu zdravotnického povolání bez přímého vedení nebo odborného dohledu
zdravotnických pracovníků, ve znění vyhlášky č. 321/2008 Sb.
Akce je akreditována u ČLK, KVVOPZ pro VŠ nelékaře a u ČAZL pro zdravotní laboranty
a všeobecné sestry – účastníci obdrží certifikát o účasti.
Educational event organised according to Professional Prescription of the Czech Medical Chamber no. 16.
Educational event organised according to Decree of the Ministry of Health of the Czech Republic no. 4/2010 Coll., which stipulates the credit system for the issue of certification for the performance of the healthcare profession without direct guidance
or professional supervision of healthcare employees, as amended by Decree no. 321/2008 Coll.
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Partneři konference
Conference Partners
Generální partner
Hlavní partner
Stříbrný partner
Bronzový partner
Mediální partneři
Media partners
5
PROGRAM KONFERENCE / CONFERENCE PROGRAM
Program konference
Conference Program
Středa, 9. dubna
Wednesday, April 9
8.00–09.15
9.30–9.45
Registrace účastníků
Participants registration
Slavnostní zahájení konference
Welcome speech to the Conference
9. 45–11.45
Session I
Development of Adult Adherent Stem Cell Therapeutics for CNS Injury and Disease
Robert Deans
Athersys, Inc., Cleveland, Ohio, USA
Cell-Free Applications of Stem Cell Therapies
Johnstone, Brian H.
Indiana University-Purdue University Indianapolis, Indianapolis, USA
Pluripotent Stem Cell-based Neural Disease Models
Yuh-Man Sun
Faculty of Medicine, the Department of Biology, Masaryk University, Brno, Czech Republic
Cook Medical - Overview and Capabilities in Regenerative Medicine
Jordi Marti
COOK Medical Inc, Bloomington, IN, USA
11.45–12.00
Coffee break
12.00–14.00
Session II – Ortopedické indikace / Orthopedic indications
Kultivované chondrocyty – naše zkušenosti, indikace a jejich limity
Cultured Chondrocytes - Our Experience, Indications and Limits
Martin Krbec, Filip Svatoš
Ortopedicko-traumatologická klinika 3. LF UK a FNKV, Praha
Department of Orthopaedics and Traumatology, University Hospital Royal Vineyards and The Third
Faculty of Medicine, Charles University, Prague, Czech Republic
Biological Resurfacing of Unicompartmental Knee and Ankle OA (Kissing Lesions) By MSCs
Stefano Zanasi
Villa Alba Hospital, Villa Maria Group, Bologna, Italy; University of Florence, Italy
Řešení chondrálních defektů nosných kloubů metodou NTC chondrograft - hodnocení
výsledků
A method of solving chondral defects of weight-bearing joints by NTC
chondrograft – evaluation of results
Petr Vališ
Ortopedická klinika Fakultní Nemocnice Brno
Department of Orthopaedics, University Hospital Brno, Czech Republic
Harvest BMAC Orthopedic Therapy Indications
Dario Ponti
Harvest Technologies Corporation, Plymouth, MA, USA
Transplantace menisku
Meniscus Transplantation
Libor Paša
Klinika traumatologie LF MU Brno, Úrazová Nemocnice Brno
Department of Traumatology, Masaryk University, Faculty of Medicine, Brno, Trauma Hospital Brno
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14.00–15.00
Oběd / Lunch
15.00–16.30
Session III
Odběry krvetvorných buněk a dalších mononukleárních elementů z periferní krve;
současné možnosti a moderní trendy.
Collection of hematopoietic stem cells and other mononuclear cells from peripheral blood;
current options and modern trends
Zdeněk Kořístek
Klinika hematoonkologie, Fakultní nemocnice Ostrava, Česká republika
International Clinical Research Center, Fakultní nemocnice u Sv. Anny, Brno
Department of Hematooncology, University Hospital Ostrava, Czech Republic
International Clinical Research Center, St. Anne´s University Hospital Brno, Czech Republic
Distribuce dovoz / vývoz krvetvorných buněk
Distribution Import / Export of Hematopoietic Stem Cells
Marie Kuříková
Institut klinické a experimentální medicíny, Praha
Institute for Clinical and Experimental Medicine, Prague, Czech Republic
Naše zkušenosti s PRP při léčbě chronických defektů
Our experience with the use of PRP in the treatment of chronic defects
Petr Šíma
Chirurgické oddělení, Fakultní nemocnice Plzeň
Surgical Department, University Hospital Plzen, Czech Republic
16.30–16.45
Coffee break
16.45–18.00
Session IV – Ischemické indikace / Ischemic indications
Stem Cell Therapy for NO-Critical Limb Ischemia and Diabetic Foot
Václav Procházka
University Hospital Ostrava, Czech Republic
Cell Therapy in NO-CLI Long-term Follow up
Berthold Amann
Asklepios Westklinikum Hamburg, Germany
Cell Therapy in NO-CLI Comparison of Therapeutical Methods
Juraj Maďarič
Národný ústav srdcových a cievnych chorôb, a.s., Bratislava, Slovensko
Autologous bone marrow stem cell : a possible solutions for end stage ischemic
cardiomyopathy
Eugenio Caradona
Fondazione di Ricerca e Cura Giovanni Paolo II (Università Cattolica del Sacro Cuore)
18.00
Závěr prvního dne konference
Conclusion of the first day of the conference
Facility Tour of National Cell and Tissue Centre (Národní Centrum Tkání a Buněk)
Gala Evening
18.00–19.00
20.00–00.00
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Čtvrtek, 10. dubna
Thursday, April 10
9.00–11.00
Session I
Cord Blood Storage: New Horizons
Keith L. March
Mutually exclusive or compatible: the future of allogeneic and autologous treatments
Frida Grynspan
Stem Cell Medicine, Israel
Factors Influencing Yield and Composition of Regenerative Cell Preparations
Eckhard Alt
InGeneron, USA
Current Hot Topics in Cell Therapy
Keith L. March
13.15–11.15
Coffee break
11.15–13.15
Session II
Endothelial progenitor cells in angiogenesis for regenerative medicine
Martin Klabusay
International Clinical Research Center, St. Anne‘s University Hospital, Brno, CZ
Regenerative medicine and cell technologies in Stem Cells Bank Pokrovsky, Russia
Alexander Smolyaninov, Varvara Bagaeva
Stem Cells Bank Pokrovsky, St. Petersburg, Russia
Bioartificial Replacements of Blood Vessels - a Review
Lucie Bačáková
Fyziologický ústav AV ČR, v.v.i., Praha
Institute of Physiology Academy of Science, Czech Republic, v.v.i.,Prague, Czech Republic
Aortic Heart Valve Replacements
Elena Filová
Fyziologický ústav AV ČR, v.v.i., Praha
Institute of Physiology Academy of Science, Czech Republic, v.v.i.,Prague, Czech Republic
13.15–14.15
Oběd/Lunch
14.15–15.45
Session III
Clinimacs Prodigy in Regenerative Medicine
Ivan Hutňan
Miltenyi Biotec, Slovensko
Regenerative Medicine: State of the Science
John Fraser
Cytori Therapeutics Inc., USA
Legislativní rámec oboru Regenerativní medicína v ČR a EU
The legislative framework for Regenerative medicine in the Czech Republic and the EU
Eva Matějková
Národní Centrum Tkání a Buněk, Brno
National Cell and Tissue Centre, Brno
KOMERČNÍ PREZENTACE: Generálního partnera BLOCK a.s.
Commercial Presentation: General Partner BLOCK a.s.
15.45–16.00
Coffee break
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16.00–17.00
Session IV – Tkáňové transplantáty/ Tissue Transplants
Skin Banking: Current Products and Future Developments
Cornelia D Richters
Euro Tissue Bank, Beverwijk, The Netherlands
Endothelial cell viability following PDAEK corneal grafting using an innovative microkeratome system
Mor M. Dickman
University Eye Clinic Maastricht
Transplantace allogenního štěpu sterna k uzávěru post-sternotomických defektů hrudní
stěny - výsledky 4 let úspěšné mezioborové spolupráce
Transplantation of allogeneic sternal bone graft for closure of post sternotomy chest wall
defects - results of four years of successful interdisciplinary collaboration
Martin Kaláb
Kardiochirurgická klinika Fakultní nemocnice Olomouc a Lékařská fakulta Univerzity Palackého Olomouc
Department of Cardiac Surgery University Hospital and Faculty of Medicine Palacky University,
Olomouc, Czech Republic
Využití moderních technologií při přípravě produktů z lidských tkání pro léčebné použití u
člověka.
The use of modern technologies in processing of human tissue products for clinical use
Ján Karkoška
Národní Centrum Tkání a Buněk, Brno
National Cell and Tissue Centre, Brno
17.00
Závěr konference / The end of Conference
9
10
REJSTŘÍK FIREM / COMPANIES DIRECTORY
Rejstřík firem
Companies Directory
BLOCK a.s.
BLOCK a.s. od svého založení v roce 1991 poskytuje komplexní služby v projektové přípravě, výrobě a výstavbě
investičních celků s náročnými technologiemi a vysokou kvalitou prostředí (čisté prostory), pro které rovněž zajišťuje následný servis a validace.
Pro realizaci náročných staveb a technologií společnost vyvinula, vyrábí a dodává komplexní systémy, které jsou
vytvářeny na základě dlouholetých zkušeností a prostorám tak zajišťují maximální spolehlivost. Tyto systémy zajišťuje v rámci sdružení firem BLOCK GROUP.
Mezi hlavní oblasti působnosti BLOCK a.s. patří farmacie a biotechnologie, chemie, laboratoře, zdravotnictví, elektrotechnika a potravinářství. Aktivní činnost vyvíjí ve střední Evropě a Rusku.
Kontaktní osoba: Ing. Zdeněk Kučera, email: [email protected], [email protected]
As of its foundation in 1991 BLOCK a.s. has been focused to complete services in the field of project preparation,
production, construction, and follow-up service of capital investment sets with demanding technologies and high
quality of environment (so called „clean rooms“) and validation.
For the implementation of demanding constructions and technologies BLOCK has developed, produced, and delivered complete systems. These have been designed on the basis of long-term experience and provide premises
with maximum reliability. BLOCK secures the production of all components for these systems within the BLOCK
GROUP.
Among the main corporate scopes of activity rank pharmacology and biotechnology, chemistry, laboratories,
health service, as well as electrical and foodstuff industries. BLOCK is active in Central Europe and in Russia, Belarus
and Ukraine.
Contact person: Zdeněk Kučera, email: [email protected], [email protected]
BIOHEM spol. s r.o.
BIOHEM was established in 1993 and today, after 12 years of existence, it profiled to a reputable distributor in Slovakia. The company supplies the Slovak pharmaceuticals and medical devices market. BIOHEM is a direct importer
of wide range of pharmaceutical products, medical devices, laboratory diagnostics and medical instruments and
has contracts with major multinational manufacturers such as BAXTER, Dade Behring, bioMerieux or Miltenyi Biotec.
EP Rožnov a.s.
EP Rožnov a.s. je projekční, inženýrská a dodavatelská společnost, která poskytuje komplexní služby v investiční
výstavbě, v oblasti náročných technologií.
Specializací firmy je projektování a realizace čistých a klimatizovaných prostor v elektrotechnickém, automobilovém a farmaceutickém průmyslu, v optice a jemné mechanice, ve zdravotnictví, ve výrobě zdravotnické techniky
i v oblasti výzkumu a vývoje.
Váš partner pro čisté prostory
Kontakt: [email protected]
EP Rožnov, a.s. is a design, engineering and supply company that provides services in the investment construction
and in the area of demanding technologies.
The company´s specialization is the design and implementation of clean rooms and air-conditioned spaces in the
sphere of electrotechnical and automotive industry, pharmacy, optics and precision mechanics, health care, production of health care technology and research and development.
Your partner for clean room
Contact: [email protected]
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HPST, s.r.o.,
Společnost HPST, s.r.o. je autorizovaným distributorem Agilent Technologies pro Českou republiku. Nabízí instrumentaci, autorizovaný servis a spotřební materiál pro atomovou a molekulární spektroskopii, plynovou a kapalinovou chromatografii, elektroforetické systémy, hmotnostní spektrometrii, disoluční zařízení, molekulární biologii
a genomiku, automatické robotické systémy, nukleární magnetickou rezonanci a rentgenovou krystalografii.
Kontaktní osoba: Daniela Tršová, manažer marketingu, e-mail: [email protected]
HPST, s.r.o. is an authorised Agilent Technologies distributor for the Czech Republic. It offers instrumentation, authorised service and consumables for atomic and molecular spectroscopy, gas and liquid chromatography, electrophoresis systems, mass spectrometry, dissolution equipment, molecular biology and genomics, automated robotic
systems, nuclear magnetic resonance and X-ray crystallography.
Contact person: Daniela Tršová, Marketing Manager, e-mail: [email protected].
Merci
Společnost MERCI, s. r.o. je profesionálním partnerem v oblasti návrhů, realizace, vybavování a zásobování
laboratoří a provozů laboratorním nábytkem, technologickými zařízeními a spotřebním materiálem. Naším
zaměřením jsou především oblasti vědy, výzkumu, průmyslu, zdravotnictví a školství.
Společnost MERCI, s. r.o. je členem České společnosti chemické, Asociace výrobců a dodavatelů zdravotnických
prostředků a držitelem ocenění Česká kvalita a dalších certifikátů.
Váš MERCI Team
Kontaktní osoba: Pavel Spáčil, tel: 724 566 400, mail: [email protected]
MERCI, s.r.o., is a professional partner in the design, construction, equipping and supplying laboratories and facilities with laboratory furniture, technological equipment and consumables. We focus primarily on science, research,
industry, healthcare and education.
MERCI, s.r.o. is a member of the Ceska Spolecnost Chemicka (Czech Chemistry Society), Association of Manufacturers and Suppliers of Medical Devices and it is a holder of the Czech Quality Certification and other certificates.
Your MERCI Team
Contact person: Pavel Spacil e-mail: [email protected]
Morys s.r.o.
Společnost MORYS s.r.o. již více než 20 let realizuje pro veřejné i soukromé investory a partnerské stavební společnosti komplexní dodávky novostaveb a rekonstrukcí, jako i specializované činnosti v oblasti technických zařízení
budov - klimatizace, vzduchotechnika, vytápění, měření a regulace, zdravotechnika, elektroinstalace.
Kontaktní osoba: Ing Radim Kviatkovský, e-mail: [email protected]
For over 20 years, the company MORYS s.r.o. has been implementing complex rendering of new buildings and reconstructions for public and private investors, as well as specialised activities in the field of technical equipment of buildings
– air conditioning, air technology, heating, measurement and regulations, sanitary facilities, electrical installations.
Contact person: Radim Kviatkovský, e-mail: [email protected]
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Trigon PLUS s.r.o.
Firma TRIGON PLUS je předním dodavatelem laboratorních přístrojů. Ke klíčovým nabízeným produktům patří
technologie čistých prostor – laminární a ochranné boxy, kultivační zařízení s kontrolovaným prostředím – inkubátory s řízenou atmosférou, pracovní boxy – izolátory s filtrací a s řízenou atmosférou, zařízení na přípravu a skladování vzorků – centrifugy, lyofilizátory, chladící, mrazící zařízení, kryotechnologie, analytické přístroje. Prioritní
činností firmy jsou komplexní služby – poradenství, prodej, školení, servis, validace a kalibrace.
Certifikace ISO 9001, akreditovaná kalibrační laboratoř
Zastoupení firmy THERMO Scientific – divize laboratorní techniky, RUSKINN, SYNGENE, LABOGENE a řady dalších.
Kontakt: www.trigon-plus.cz, [email protected], tel. +420 272 680 190
The company TRIGON PLUS is one of the leading laboratory equipment suppliers. To the key offered products
belongs clean rooms technologies – laminar and safety boxes, culture systems with controlled atmosphere – incubators with CO2/O2 control, workstations - isolators with filtration and CO2/O2 control, equipment for sample
preparation and storage – centrifuges, freeze dryers, freezers, cold storage and cryopreservation equipment, analytical systems. The priority of the company is to offer complex services – consultancy, sale, training, service, validation and calibration.
Certification ISO 9001, accredited Calibration Laboratory
Representative of companies THERMO Scientific – Laboratory Equipment Division, RUSKINN, SYNGENE, LABOGENE
and many others.
Contact: www.trigon-plus.cz, [email protected], telephone +420 272 680 190
VIVACOM s.r.o.
VIVACOM je moderní společností v oblasti péče o zdraví, zaměřenou na průzkum a marketing zdravotnických
výrobků a zařízení. Hlavní vizí firmy je příspěvek společnosti prostřednictvím péče o zdraví, za pomoci unikátních
technologií, které umožňují, aby lékařská péče byla vlídnější a příjemnější.
Především si uvědomujeme, že spokojenost zákazníků je primárním elementem úspěchu ve vztahu s nimi a pracujeme společně, abychom vám poskytli mimořádné služby a co největší výběr kvalitních výrobků.
Kontaktní osoba: Michal Vikus, Managing Director, e-mail: [email protected]
VIVACOM s.r.o. is a modern company providing services in the area of healthcare which focuses on research and
marketing of healthcare products and equipment. The company’s key vision is to contribute to the society via healthcare using unique technologies which allow it to be more patient-friendly and comfortable.
We are acutely aware that patient satisfaction is paramount for establishing a successful relationship with them and
we work together to provide you with extraordinary services and the broadest selection of quality products possible.
Contact person: Michal Vikus, Managing Director, e-mail: [email protected]
Frigomont a.s.
Frigomont a.s. zajišťuje vybavení operačních sálů, laboratoří, farmaceutických provozů včetně stavební a výrobní
technologie, projektů, inženýringu a stavebního dozoru.
Frigomont provides equipment for operating rooms, laboratories, and for pharmaceutical operations including
construction and manufacturing technologies, design and engineering and construction supervision.
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SBORNÍK ABSTRAKT
ABSTRACT BOOK
15
OBSAH / CONTENT
Obsah
Content
Development of Adult Adherent Stem Cell Therapeutics for CNS Injury and Disease . . . . . . . . . . . . . . 20
Cell-Free Applications of Stem Cell Therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Pluripotent Stem Cell-based Neural Disease Models. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Cook Medical - Overview and Capabilities in Regenerative Medicine . . . . . . . . . . . . . . . . . . . . . . . . 23
Kultivované chondrocyty – naše zkušenosti, indikace a jejich limity . . . . . . . . . . . . . . . . . . . . . . . . 24
Cultured Chondrocytes - Our Experience, Indications and Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Biological Resurfacing of Unicompartmental Knee and Ankle OA (Kissing Lesions) By MSCs. . . . . . . . . 25
Ošetření chondrálních defektů nosných kloubů metodou implantace solidního chondrograftu . . . . . . 27
Treatment of Chondral Defects of Weight-Bearing Joints by Implanting Solid Chondrograft. . . . . . . . . 27
Harvest BMAC Orthopedic Therapy Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Transplantace menisku . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Meniscus Transplantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Distribuce dovoz / vývoz krvetvorných buněk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Distribution Import / Export of Hematopoietic Stem Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Naše zkušenosti s PRP při léčbě chronických defektů . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Our Experience with the Use of PRP in Treatment of Chronic Defects . . . . . . . . . . . . . . . . . . . . . . . . 33
Stem Cell Therapy for NO-Critical Limb Ischemia and Diabetic Foot . . . . . . . . . . . . . . . . . . . . . . . . . 35
Cell Therapy in No-option Critical Limb Ischemia – Comparison of Therapeutic
Methods and Predictors of Therapeutic Effect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Cell therapy in No-option CLI: state of the art and long-term results . . . . . . . . . . . . . . . . . . . . . . . . 38
Autologous bone marrow stem cell: a possible solutions for end stage
ischemic cardiomyopathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
The enhancement of T cell-mediated immune responses through the use of beta lactams. . . . . . . . . . . 42
Factors Influencing Yield and Composition of Regenerative Cell Preparations . . . . . . . . . . . . . . . . . . 43
Regenerative Medicine and Cell Technologies in Stem Cells Bank Pokrovsky, Russia . . . . . . . . . . . . . . 44
Bioartificial Replacements of Blood Vessels – a Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Aortic Heart Valve Replacements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Clinimacs Prodigy in Regenerative Medicine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
16
OBSAH / CONTENT
Legislativní rámec oboru Regenerativní medicína v ČR a EU. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
The Legislative Framework for Regenerative Medicine in the Czech Republic and the EU . . . . . . . . . . . 48
Transplantace allogenního štěpu sterna k uzávěru post-sternotomických defektů hrudní
stěny – výsledky 4 let úspěšné mezioborové spolupráce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Transplantation of allogeneic sternal bone graft for closure of post sternotomy chest wall
defects – results of four years of successful interdisciplinary collaboration . . . . . . . . . . . . . . . . . . . . 49
Skin Banking - Current Products and Future Developments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
The use of modern technologies in processing of human tissue products for clinical use . . . . . . . . . . . 51
17
SEZNAM PŘEDNÁŠEJÍCÍCH / THE LIST OF SPEAKERS
Seznam přednášejících
The list of speakers
Eckhard Alt
InGeneron, USA
Berthold Amann
Varvara Bagaeva
Stem Cells Bank Pokrovsky, St. Peterburg, Russia
Lucie Bačáková
Fyziologický ústav AV ČR, v.v.i. / Institute of Physiology, Academy of Sciences of the Czech Republic, v.v.i.
Brian H. Johnstone
Eugenio Caradona
Fondazione di Ricerca e Cura Giovanni Paolo II (Università Cattolica del Sacro Cuore), Italy
Robert Deans
Athersys, Cleveland, Ohio, USA
Mor M. Dickman
University Eye Clinic Maastricht, The Netherlands
Elena Filová
Fyziologický ústav AV ČR, v.v.i. / Institute of Physiology, Academy of Sciences of the Czech Republic, v.v.i.
John Fraser
Cytori Therapeutics Inc., USA
Frida Grynspan
Stem Cell Medicine, Israel
Ivan Hutňan
Miltenyi Biotec, Slovakia
Martin Kaláb
Fakultní nemocnice Olomouc / University Hospital Olomouc, Czech Republic
Ján Karkoška
Národní Centrum Tkání a Buněk, Brno / National Cell and Tissue Centre, Brno, Czech Republic
Martin Klabusay
International Clinical Research Center, St. Anne‘s University Hospital, Brno, Czech Republic
Zdeněk Kořístek
Klinika hematoonkologie, Fakultní nemocnice Ostrava / Department of Hematooncology, University Hospital
Ostrava, Czech Republic / International Clinical Research Center, St. Anne´s University Hospital Brno, Czech Republic
18
SEZNAM PŘEDNÁŠEJÍCÍCH / THE LIST OF SPEAKERS
Martin Krbec
Fakultní nemocnice Královské Vinohrady, Praha / University Hospital Royal Vineyards, Prague, Czech Republic
Marie Kuříková
Český registr dárců krvetvorných buněk, Institut klinické a experimentální medicíny, Praha
Czech Stem Cells Registry, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
Juraj Maďarič
Národný ústav srdcových a cievnych chorôb, a.s., Bratislava, Slovensko / The National Institute of Cardiovascular
Diseases, Bratislava, Slovakia
Keith L. March
Indiana University-Purdue University Indianapolis, Indianapolis, In, USA
Jordi Marti
Eva Matějková
Národní Centrum Tkání a Buněk, Brno / National Cell and Tissue Centre, Brno, Czech Republic
Libor Paša
Úrazová nemocnice Brno / Trauma Hospital Brno, Czech Republic
Václav Procházka
Fakultní nemocnice Ostrava, / University Hospital Ostrava
Cornelia D Richters
Euro Tissue Bank, Beverwijk, The Netherlands
Dario Ponti
Harvest Technologies Corporation, Plymouth, MA, USA
Alexander Smolyaninov
Stem Cells Bank Pokrovsky, St. Peterburg, Russia
Yuh-Man Sun
Biologický ústav Lékařské fakulty, Masarykova univerzita Brno, Česká republika / Faculty of Medicine,
the Department of Biology, Masaryk University, Brno
Filip Svatoš
Fakultní nemocnice Královské Vinohrady, Praha
University Hospital Royal Vineyards
Petr Šíma
Fakultní nemocnice Plzeň / University Hospital Pilzen, Czech Republic
Petr Vališ
Fakultní nemocnice Brno / University Hospital Brno, Czech Republic
Stefano Zanasi
Villa Alba Hospital, Bologna (Italy) / Clinical Professor University of Florence, Italy
19
SBORNÍK ABSTRAKT / ABSTRACT BOOK
Development of Adult Adherent Stem Cell Therapeutics for CNS Injury and
Disease
Robert Deans
Athersys, Inc., Cleveland, Ohio, USA
Adult stem cell therapeutics have entered an exciting development phase, with late phase clinical studies supporting approval studies in disease settings of significant unmet need. Athersys has created a clinical manufacturing
platform for an adherent bone marrow derived cell product, MultiStem®, and is in Phase II development for treatment of stroke with a pipeline of activity in TBI, spinal cord and multiple sclerosis. Emphasis has been placed on
understanding mechanistic action and biodistribution of infused cells, with increased understanding that modulation of the systemic immune system is central at driving repair of acute CNS injury. Data will be presented from preclinical models of CNS disease with relevance to optimizing clinical design and progressing to commercialization.
20
Cell-Free Applications of Stem Cell Therapies
Brian H. Johnstone, Yansheng Du and Keith L. March
Indiana University School of Medicine, Indianapolis, Indiana, USA
Adipose-derived stem cells (ASC) are a plentiful source of multipotent cells obtained by minimally invasive extraction methods from subcutaneous adipose tissues. ASC share many phenotypic and physiological attributes with
bone marrow-derived mesenchymal stem cells (BM-MSC). It is becoming increasingly evident that the predominant mode of action of both cell types is paracrine support of endogenous tissues. We have been investigating the
therapeutic potential of a cell-free product consisting of paracrine factors produced during culture of ASC. This
ASC-conditioned medium (ASC-CM) protects and repairs neurons of the central and peripheral nervous systems;
importantly, even when administered following the initial insult. Employing a neonatal model of hypoxia-ischemia
(HI) injury (or birth asphyxia), robust preservation of brain volume and function was maintained with intravenous
administration of ASC-CM up to 36 hours after inducing injury. Similarly, administration of ASC-CM to mice transgenic for a mutation in the superoxide dismutase-1 (SOD-1) gene associated with familial amytrophic lateral sclerosis (ALS), significantly extended the lifespan of these mice. Neutralization of either insulin-like growth factor-1
(IGF-1) or brain-derived neurotrophic factor (BDNF) reduced but did not abolish the neuroprotective activity of
ASC-CM in the HI injury model. Thus, the neuroprotective activity of ASC-CM is produced by a combination of
potent neurotrophic and survival factors functioning together and individually to affect protection and repair of
damaged tissues. Current efforts are directed at developing a good manufacturing process for ASC-CM production
that follows current international regulatory standards for cell and tissue products. The goal is to develop off-theshelf ASC-CM drug for the treatment of severe neurological diseases.
21
Pluripotent Stem Cell-based Neural Disease Models
Yuh-Man Sun
Faculty of Medicine, the Department of Biology, Masaryk University, 625 00 Brno, Czech Republic
The advent of technological developments in embryonic stem cells (ESCs) and induced pluripotent stem cells
(iPSCs) is changing the landscape of biomedical research by shifting model organism-based disease systems to
pluripotent stem cell-based disease systems. Conventional research often interprets biological phenomena in humans using the wealth of knowledge that is extrapolated from model organism-based studies, which may cause
erroneous translations due to the species’ differences derived from evolutionary gaps. Pluripotent stem cell-based
disease models offer desirable patient–based (or personalised) disease systems without breaking the ethical constraints and also circumvent the difficulties in obtaining samples. We are interested in adopting the cutting-edge
iPSC technology, which enables the generation of neurons and glias straight from patients’ skin biopsies. The iPSC
technology transforms the skin samples of individual patients into a personalized cellular-basis neural cultural system, by which the personal neural cells that are engraved with the characteristic signatures from original donors
will provide a tool for uncovering the cause of aberrant functions in patient brains. The iPSC and ESC technology
provides a powerful tool for investigating gene functions in patients’ samples and supplies endless samples for
research.
22
Cook Medical - Overview and Capabilities in Regenerative Medicine
Jordi Marti
For the last 50 years, Cook Medical has worked with researchers and physicians across 42 medical specialties to
develop simpler, more effective therapeutic tools. Today these tools support emerging cell therapies and regenerative medicine technologies, helping to advance these promising treatments from the lab to the patient. Cook laboratory products such as human platelet lysate and cryogenic storage vials enable the efficient and safe production
of cell therapies, while newly developed devices – a cardiac catheter, an infusion needle, and a pressure transducer
– bring control to the delivery of cells to the patient. Finally, a Cook extracellular matrix material (SIS) continues to
provide a regenerative therapy option for patients suffering from a variety of medical conditions.
23
Kultivované chondrocyty – naše zkušenosti, indikace a jejich limity
Svatoš F., Bartoška R., Čech P., Klézl Z., Džupa V., Krbec M.
Fakultní nemocnice Královské Vinohrady, Praha
Autoři hodnotí vlastní soubor 48 pacientů s implantovanými kultivovanými chondrocyty. Podávají přehled indikací,
dělí pacienty a výsledky dle lokalit vhodných k implantaci. Dále seznamují s vlastním průběhem odběru, kultivace
i implantace chondrograftu. Podávají přehled o vývoji Lysholmova skóre v průběhu léčby. Poukazují na limity implantací. Ukazují vlastní pohled na indikace a kontraindikace a zhodnocení komplikací a jejich řešení. V neposlední
řadě pak seznamují s úskalími vlastní metody i procesu odběru a zpracování graftu a seznamují s legislativními překážkami. Na několika krátkých kazuistikách ukazují úspěchy, ale i neúspěchy u vlastních pacientů souboru a dávají
ke zvážení změny celého procesu, včetně indikačních kritérií.
Cultured Chondrocytes - Our Experience, Indications and Limits
Svatoš F., Bartoška R., Čech P., Klézl Z., Džupa V., Krbec M.
University Hospital Royal Vineyards, Prague, Czech republic
The authors evaluated their own sample group of 48 patients with implanted cultivated chondrocytes. They present an overview of the indications, and divide the patients and results according to localities suitable for implantation. They also provide an outline of the actual course of the taking, cultivation and implantation of the chondrograft. They present an overview of the development of the Lysholm score during the course of treatment, and draw
attention to the limits of implantations. The authors additionally present their own view of the indications and
contraindications, as well as an assessment of the complications and the solutions thereto. Last but not least they
familiarise us with the range of their own methods in the process of taking and processing the graft, and present an
outline of the legislative obstacles. In a number of brief case studies they show the successes and also the failures
in the patients within the sample group and present potential changes to the entire process, including indication
criteria, for our consideration.
24
Biological Resurfacing of Unicompartmental Knee and Ankle OA (Kissing
Lesions) By MSCs
Stefano Zanasi, Gaetano Maci, Gaetano Carriere, Monica Pastina
Corresponding Author: Stefano Zanasi
Villa Alba Hospital, Villa Maria Group, Bologna, Italy
Introduction
Lesions involving articular cartilage of the knee and talus are extremely common in clinical practice and affect
scores of individuals worldwide. Their origin is frequently traumatic in nature, although degenerative cartilage
pathologies also compose a large proportion of cases. Early therapy is important as untreated lesions have the
tendency to become chronic, increasing in both size and severity so that requiring implant arthroplasty. In fact,
cartilage tissue has a low intrinsic capacity for regeneration and as such does not heal spontaneously, therefore,
the damage may be irreversible and lead to chronic symptoms and early osteoarthritis, with a share ranging from
17% to 50% of cases. Various surgical options have been proposed to repair knee and talar dome cartilage defect, but among them, only osteochondral grafting and autologous chondrocyte implantation have shown the
ability to provide reconstruction of the lesion site with hyaline cartilage. Nevertheless, the need for two operations and high costs remain drawbacks of autologous chondrocyte implantation. Mesenchymal stem cells (MSCs)
are proposed as a new option for treatment of articular cartilage defects because of their ability to differentiate
into various lineages, including osteoblasts and chondrocytes. MSC differentiation in the specific track may be
achieved as a result of environment, mechanical stimulation, and growth factors present in the platelet gel, able
to stimulate cells toward osteogenesis and chondrogenesis. The potential of a multipotent cell may be considered
not only an intrinsic capability of the cell alone but also the interaction between a cell with its physiologic niche
that provides a signaling network (ie, the extracellular matrix, adhesion molecules, growth factors, cytokines, and
chemokines secreted by the resident cells). Autologous bone marrow contains not only stem cells and precursor
cells as a source of regeneration tissue, but also accessory cells that support angiogenesis and vasculogenesis by
producing several growth factors. This suggests no cell selection and expansion in the laboratory may be required
(as with autologous chondrocyte implantation), and consequently the transplant can be performed in one operative procedure. In patients younger than 50 years, affected by unicompartmental osteoarthritis of the knee or ankle, to avoid or delay implant arthroplasty, we have obtained very promising results by biological coating of both
kissed joint cartilage defects resorting to MSCs.
Materials and Methods
From 6/2008 to 12/2011 we implanted MSCs by arthroscopic or mini-open technique in 31 patients (16m/15f )
affected by unicompartmental osteoarthritis Ahlback stage II/III for medial (5) and lateral (2) unicompartmental femuro-tibial OA, patella-femoral joint OA (18), and 6 unshouldered kissed ankle large defects. The average age was
32yrs. (19-55). All patients were followed for a minimum follow-up of 24months (12-42ms). We excluded patients
younger than 15 years or older than 55 years. Malalignment of the lower limb and the presence of joint laxity were
considered relative contraindications to be corrected if present. The ethical committee of our institution approved
the human protocol for this investigation and written informed consent was signed by all the patients enrolled in
this study. The mean size of the lesions was 9.5cm2 (range 5.5 – 27 cm2), and the mean depth of the lesions was
4.2 ± 1.4 mm. We recorded the ICRS as well as AOFAS score preoperatively. A standard radiographic examination,
including AP and lateral weightbearing views and MRI of the affected joints were performed preoperatively. The
scaffold used in this series for cell support was a hyaluronic acid membrane (HYAFF®-11; Fidia Advanced Biopolymers) with addition of platelet gel. The secretory granules of platelets, the α granules, contain platelet-derived
growth factors AA, BB, and AB; transforming growth factors β1 (TGF-β1) and β2; platelet-derived epidermal growth
factor; platelet-derived angiogenesis factor; insulin growth factor 1; and platelet factor 4, which influences bone
regeneration. Because of commercial availability, the first 23 patients were treated using as a scaffold the hyaluronic acid membrane, whereas the last 8 patients received in addition to the graft an human amniotic membrane
patch covering by the stromal face. The technique consists of taking, using a disposable kit, 60 ml of bone marrow
aspiration from the ipsilateral anterior iliac crest in a sterile regimen, with the patient in a supine decubitus position
and under general or spinal anesthesia, and centrifuging (Harvest PreP2 Smart System i.e.) 5-6 times to concentrate
contained mesenchymal cells in the bone marrow. Through the use of thrombin from autologous blood collection,
25
you can turn the bone marrow and produce a concentrated gel : Hyaluronic acid membrane is cut in an appropriate size following the area of the lesion and loaded by capillarity with 2 mL bone marrow concentrate and 1 mL
platelet-rich fibrin gel (Harvest SmartPReP®2 APC+™System) to reconstruct both side of the kissed chondral defect
with miniopen or arthroscopic procedure. In the last 8 cases Human Amniotic Membrane by Tissues Bank was positioned with the stromal side over the graft surface and fixed with fibrin glue (Tissucol, Baxter). Patients are then
directed to a specific rehabilitation program.
Results
We followed patients at 3, 6, 12, 18, and 24 months after surgery. The clinical evaluation was performed using the
ICRS-IKDC and AOFAS protocol; the evaluation of the cartilage was performed by a 1.5T MRI imaging and processing was performed by MOCART scoring system. The EuroQol EQ-5D was used to assess the quality of life of patients.
The ICRS-IKDC and AOFAS scoring documented a statistically significant improvement in clinical objective and
subjective data (p0.0001). We had no intraoperative as well as postop complications. The mean preoperative ICRSIKDC as well as AOFAS score were respectively 56.4 ± 16.5 and 51±11.2. The mean ICRS-IKDC as well as AOFAS score
improved to 81.3 ± 6.7 at 6 months follow-up, 88.2 ± 7.6 at 12 months, 89.9 ± 4.5 at 18 months, and 90.4 ± 3.7 at
24 months. The EuroQol EQ-5D index was significantly improved compared to baseline in all patients. NMR imaging at 3,6,12 and 24 ms f.up revealed a complete filling of the defect in 91%, a complete integration of the border
area with the adjacent cartilage in 94% with intact and homogeneous tissue repair and intact subchondral lamina
and subchondral bone in 89% and 78% of cases respectively, with total average MOCART score of 87out of 100. It
has not been demonstrated at clinical as well X-Ray film f.up progression of preoperative OA. The 12 ms to 24ms
second-look surgery 6 cases showed good coverage (> 90%) and the integration of the grafts. Histology at 12 ms.
f.up documented hyaline fibrous tissue with a high content of collagen type II and proteoglycans, that is the maturation in progress of implanted MSCs to a clear fibro-hyaline-like phenotype without peculiar cell organization.
Discussion and Conclusions
These results suggest that MSCs resurfacing procedure even in severe unicompartmental osteoarthritis demonstrates as an effective treatment for a biological coating that provides at least at medium-term data, remission
of pain and swelling, with good functional recovery and the ability to resume previous work activity and finally
it demonstrates overlapping outcome vs ACT procedure with the advantage of a single operative step, without
requiring removal of a cartilage sample for cloning in a specialized center and replanting after about 40 days, with
consequent and important cost reductions.
26
Ošetření chondrálních defektů nosných kloubů metodou implantace solidního
chondrograftu
Vališ P., Otaševič T., Rouchal M., Novák J., Repko M., Krbec M., Šprláková A´
Ortopedická klinika Fakultní Nemocnice Brno
Úvod
Léčba chondrálních a osteochondrální defektů nosných kloubů (kolene, hlezna) představují stále vážný terapeutický problém, především pro minimální schopnost reparace hyalinní kloubní chrupavky. K hlavním příčinám poškození kloubní chrupavky řadíme traumata, opakované mikrotraumatizace a avaskulární nekroźy. Všechny defekty kloubního povrchu je nutné považovat za preartrotický stav. Nejspolehlivější zobrazovací metodou, která určí
rozsah poškození chrupavky i pod ní ležící kosti zůstává magnetická resonance. Přímé posouzení stavu kloubního
povrchu a poměrů v kloubu a současné ošetření defektu umožňuje artroskopie. V současné době je popsáno velké
množství postupů k ošetření chondrálních defektů.
Materiál a metoda
Metodu implantace solidního chondrograftu s využitím autologních chondrocytů pro ošetření defektů nosných
kloubů používáme na naší klinice od roku 2001. Za tu dobu bylo odoperováno celkem 132 pacientů. U 79 byl defekt lokalizován na kondylech femuru, ve 21 případech na patele a 31 v oblasti hlezenního kloubu, u 1 pacientky se
jednalo o náhradu chrupavky v loketním kloubu. Průměrný věk pacientů v době implantace činí 29 let. Interval pooperační sledování 5–156 měsíců, průměrná doba sledování 46 měsíců. Při výrobě solidního chondrograftu jsme
spolupracovali s Tkáňovou bankou FN Brno, v současné době výrobu zajišťuje Národní tkáňové centrum Brno. Při
operacích na kolenním kloubu jsme připojili ve 20 případech plastiku LCA a 1 x plastiku LCA a LCP a ve 13 případech
plastiku závěsného aparátu pately. Při kontrolních ASK jsme odebírali vzorky z místa původní implantace chopndrograftu a histologicky je hodnotili
Výsledky
Pooperační sledování zahrnuje pravidelné klinické vyšetření a vyplnění Lysholmovy bodovací stupnice. S odstupem jednoho, dvou a pěti let od operace pacientům bylo provedena kontrolní MRI vyšetření.
Závěr
Dle našich zkušeností právě tato metoda poskytuje nejlepší klinické výsledky a zajišťuje obnovu hyalinní kloubní
chrupavky.
Treatment of Chondral Defects of Weight-Bearing Joints by Implanting
Solid Chondrograft
Vališ P., Otaševič T., Rouchal M., Novák J., Repko M., Krbec M., Šprláková A´
Department of Orthopedics, University Hospital Brno, Czech Republic
Introduction
Treatment of chondral and osteochondral defects of weight-bearing joints (knee, ankle) still represents a serious
therapeutic problem, primarily for the minimal ability to repair the articular hyaline cartilage. Main causes of damage to articular cartilage include trauma, repetitive microtraumatisation and avascular necrosis. All the defects of
the articular surface must be considered to be a pre-arthritis condition. Magnetic resonance remains to be the
most reliable imaging method which determines the extent of damage to the cartilage and the bone located
under it. Arthroscopy allows for direct assessment of the articular surface and the conditions in the joint and for
treatment of the defect. A number of procedures are currently described for the treatment of chondral defects.
27
Material and Method
The method of implanting a solid chondrografts using autologous chondrocytes to treat defects in weight-bearing
joints has been used at our clinic since 2001. Over this period of time, surgery has been provided to a total of
132 patients. In 79 of them a defect was localised on femoral condyle, in 21 cases on the patella and in 31 in the
ankle area. In 1 patient a replacement of cartilage in the elbow joint was provided. The average age of patients
at the time of implantation is 29. The postoperative follow-up interval ranges from 5 to 156 months, the average
follow-up time is 46 months. The solid chondrograft was manufactured together with Tissue Bank at the University
Hospital in Brno. Currently, it is manufactured by National Cell and Tissue Centre, Brno. Of knee joint operations,
we carried out ACL reconstruction in 20 cases and once both ACL and PCL reconstructions and in 13 cases a reconstruction of the attachment apparatus of patella. In the follow-up arthroscopies, samples were taken from the
location of the original implantation of chondrograft and were subjected to histological examination.
Results
The post-operative monitoring includes regular clinical examination and filling out the Lysholm scoring scale. After
one, two and five years from the surgery, patients were given a follow-up MRI examination.
Conclusion
Based upon our experience, this method provides the best clinical results and ensures restoration of hyaline articular cartilage.
28
Harvest BMAC Orthopedic Therapy Indications
Dario Ponti
Harvest Technologies Corporation, Cellular Therapy & Education, Plymouth, MA, USA
Harvest Technologies has decades of cumulative experience designing, manufacturing and marketing devices for
physiological biologic component separation, platelet sequestration, bone marrow derived
stem cell harvesting and adipose graft consolidation.
Our mission is focused on the development of unique, risk based approach techniques employing user friendly
technologies empowering physicians to treat a wide variety of serious vascular, orthopedic and cardiovascular
diseases based on evidence based research thereby improving surgical outcomes by accelerating the body’s own
natural healing process.
The Harvest SmartPReP System technology is a point of care multi-biologic platform to produce various Autologous Regenerative Cell (ARC) concentrates ranging from peripheral blood to produce Autologous Platelet Concentrate (APC+®), bone marrow aspirate to produce Bone Marrow Aspirate Concentrate [BMAC®] and liposuction
adipose tissue to produce AdiPReP® Graft Matrix.
29
Transplantace menisku
Libor Paša
Klinika traumatologie Lékař. Fakulty MU Brno, Úrazová nemocnice Brno
Úvod:
Autoři prezentují své zkušenosti s transplantací hluboce mražených menisků.
Metoda:
Po odstranění poraněné části menisku se zvyšuje zátěž na měrnou jednotku chrupavky kolenního kloubu 3-4x
oproti zdravému. Tyto změny vedou k časnému opotřebení chrupavek a následné poúrazové artróze. Transplantace menisku umožní zmírnit zátěžové síly na chrupavku a tím oddálit její opotřebení. Vhojení tkáně hluboce mraženého alogenního menisku
Materiál:
Autoři provedli celkem 71 transplantací menisku u 69 pacientů v období 2002-2013. Prvních 17 pacientů bylo odoperováno pomocí artrotomie, další pacienti již pomocí artroskopické techniky. Fixace obou rohů menisků byla vždy
přes kostní kanálky k tibiálnímu platu, baze menisků byla fixována ke kloubnímu pouzdru pomocí stehů. V případě
současné nestability byla provedena i rekonstrukce zkřížených vazů, v případě osové anulace do varozity byla provedena valgizační osteotomie proximální tibie, u 11 pacientů ve 2 dobách, u 12 pacientů současně s transplantací.
Výsledky:
Ve všech případech došlo ke vhojení transplantátu menisku. Ve 3 případech byla provedena artroskopie do 4 měsíců od transplantace, 1x pro bolesti nálezem 2 cm nepřihojené části menisku, která byla okrvavena a ošetřena
3 stehy, 2x pro výrazný nástup artrofibrotických změn, které byly při artroskopii odstraněny.
K poranění transplantátu došlo u 2 pacientů, v období 25 a 29 měsíců od operace, u obou byla provedena menisektomie poraněné části menisku.
Hodnota IKDC byla před transplantací v průměru 59, zatímco po 2 letech byla v průměru 81, Lysholm skore bylo
v průměru 62 před operací a 91 po 2 letech.
Diskuse:
Transplantace menisku zlepšila životní komfort v 70 případech pozitivně, pouze u 1 pacienta byly udávány potíže
výraznější, než před operací (artrofibroza). Zhodnocení rtg a subjektivního skore po 5 letech vykazovalo stacionární
hodnoty a nedocházelo k progresi klinických potíží a artrotických změn i přesto, že 68% pacientů začalo klouby
zatěžovat více, než před transplantací z důvodů snížení klinických potíží.
Závěr:
Transplantace alogenní tkáně menisku je metoda, která přináší zlepšení pohybového komfortu pacienta a dle
našeho sledování přispívá ke zmírnění až zastavení progrese artrotických změn po předchozí menisektomii.
Meniscus Transplantation
Libor Paša
Traumatology Clinic of the Medical Faculty of Masaryk University in Brno,
Trauma Hospital Brno
Introduction:
The authors present their experiences with the transplantation of deep-frozen menisci.
30
Method:
After removing the injured part of the meniscus, the burden on the unit of measure of the knee joint cartilage is
increased by 3-4x as against a healthy one. These changes lead to premature deterioration of the knee joint and
subsequently to post-accident arthrosis. Transplantation of the meniscus enables alleviation of burden forces on
the knee joint, thus delaying its deterioration. The recovery of tissue of a deep-frozen allogeneic meniscus
Material:
The authors carried out a total of 71 meniscal transplants in 69 patients during 2002-2013. The first 17 patients
were operated with the aid of arthrotomy, the remaining patients with the aid of arthroscopic technology. The
fixation of both menisci corners was always via the ostial valves to the tibial plateau, the base of the menisci was
fixed to the joint capsule with the aid of stitches. Reconstruction of the crossed ligaments was carried out in cases
of current instability, valgisation osteotomy of the proximal tibia was carried out in cases of axial annulment, in two
periods in 11 patients, simultaneously with the operation in 12 patients.
Results:
Recovery of the meniscal graft occurred in all cases. In 3 cases, an arthroscopy was carried out within 4 months of
the transplant: 1x due to pain located in a 2 cm part of the meniscus which had not healed, the blood of which
was drained and treated with 3 stitches; 2x due to marked commencement of arthrofibrotic changes, which were
removed by arthroscopy.
Injury of the graft occurred in 2 patients, during a period of 25 and 29 months after the operation. A meniscectomy
of the injured part of the meniscus was carried out in both.
The IKDC value was at an average of 59 prior to the operation, whereas after 2 years it was at an average of 81; the
Lysholm score was at an average of 62 prior to the operation and 91 after two years.
Discussion:
Transplantation of the meniscus improved life comfort positively in 70 cases; only in one patient were ostensive difficulties more marked than prior to the operation (arthrofibrosis). The radiographic evaluation and subjective score
after 5 years demonstrated stationary values, and progression of clinical difficulties and arthritic changes did not
occur even despite the fact that the joints started to burden 68% of patients more than prior to the transplantation
due to a reduction of clinical difficulties.
Conclusion:
Transplantation of the allogeneic meniscal tissue is a method which brings improvement to a patient’s comfort
of movement, and according to our monitoring it contributes to the alleviation to cessation of the progression of
arthritic changes after a preceding meniscectomy.
31
Distribuce dovoz / vývoz krvetvorných buněk
Marie Kuříková
Český registr dárců krvetvorných buněk
V přednášce bude prezentován přehled mezinárodní spolupráce Českého registru dárců krvetvorných buněk
(CSCR), která je nezbytná pro zajištění tohoto typu transplantací. Dalším tématem bude srovnání legislativních
požadavků na zajištění transportu v jednotlivých ze¬mích. Registr také funguje v souladu s mezinárodními akreditačními požadavky, které budou prezentovány s důrazem na transplantace hematopoetických kmenových buněk.
Dále bude představena problematika přípravy transportu krvetvorných buněk pro vývoz i dovoz. Samostatnou
kapitolou pak bude přehled možných nežádoucích událostí při transportu.
Distribution Import / Export of Hematopoietic Stem Cells
Marie Kuříková
Czech Stem Cells Registry
Institute for Clinical and Experimental Medicine, Prague, Czech Republic
The lecture will present an overview of international collaboration of the Czech Stem Cells Registry (CSCR) necessary to provide for this type of transplantation. Another theme consists of a comparison of legislative requirements
for transport conditions in individual countries. The Register also operates in keeping with international accreditation requirements which shall be presented with an emphasis on hematopoietic stem cell transplantation.
Further, the issue of preparation necessary for hematopoietic stem cells transport designated both for export and
import will be presented. An independent topic will consist of an overview of potential adverse events during
transport.
32
Naše zkušenosti s PRP při léčbě chronických defektů
P. Šíma, M. Blažek, V. Karnos, V. Šanda
Chirurgické oddělení Fakultní nemocnice Plzeň, primář: MUDr. V. Karnos
Projekt č. TA02011402 byl řešen s finanční podporou TA ČR program ALFA.
Úvod
Postupně narůstající počet diabetických a ischemických ran dolních končetin vede k novým přístupům léčby těchto defektů. Práce představuje prvotní zkušenosti s léčbou ran pomocí obohacené krevní plasmy na chirurgickém
oddělení.
Materiál a metodika
Pacienti byli randomizováni do léčebné a kontrolní skupiny. Do studie jsme zařadili 40 pacientů s chronickým defektem, 25 pacientů bylo léčeno obohacenou krevní plasmou. Kontrolní skupinu tvořilo 15 nemocných léčených
konvenční terapií. Planimetricky bylo hodnoceno zmenšování plochy a hloubky defektu v obou skupinách. Nemocní byli kontrolováni 0., 14., 28. den a dále v měsíčních intervalech, výsledky obou skupin byly porovnány a statisticky vyhodnoceny.
Výsledky
V léčebné skupině došlo u 8 nemocných ke kompletnímu zhojení defektu během 6ti měsíců, u ostatních došlo k signifikantnímu snížení velikosti defektu. V léčebné skupině došlo ke zmenšení plochy defektu o 2,4 cm2 /+-2,4cm2 /
a snížení hloubky defektu o 2,1mm/+-2,5/, v porovnání s kontrolní skupinou, kde změna plochy defektu byla –
1,3cm2 /+-2,1cm2/ a změna hloubky – 1,0 mm /+-2,9mm/
Závěr
Prokázali jsme, že použití obohacené plasmy při léčbě chronických defektů má pozitivní význam na granulační
i epitelizační fázi hojení. Jedná se o novou metodu léčby, kde je zapotřebí přesně stanovit indikační kritéria použití.
Klíčová slova
diabetická noha - obohacená plasma – vlhké krytí
Our Experience with the Use of PRP in Treatment of Chronic Defects
P. Šíma, M. Blažek, V. Karnos, V. Šanda
Department of Surgery, University Hospital Pilsen, Czech Republic, Chief physician: MUDr. V. Karnos
Introduction
The gradually increasing number of diabetes and ischemic wounds of the lower limbs leads to new approaches
to treatment of these defects. The paper presents our initial experience with treatment of wounds using enriched
blood plasma at the surgery department.
Material and methodology
Patients were randomised into a treatment group and a control group. The study included 40 patients with a chronic defect; 25 patients were treated with enriched blood plasma. The control group consisted of 15 patients treated
with conventional therapy. Planimetry was used to evaluate the reduction of the area and defect depth in both
groups. Patients were checked on day 0, 14 and 28 and, subsequently, in monthly intervals. The results from both
groups were compared and statistically evaluated.
33
Results
In the treatment group, a total healing occurred in 8 patients during 6 months; in the other patients, there was
a significant decrease in the defect size. In the treatment group the surface decreased by 2.4 cm2 /+-2.4cm2 / and
the defect depth reduced by 2.1mm/+-2.5/ compared to the control group in which the change in the defect surface amounted to – 1.3cm2 /+-2.1cm2/ and the change of depth reached – 1.0 mm /+-2.9mm/
Conclusion
We demonstrated that the use of enriched blood plasma in the treatment of chronic defects has a positive impact
on both the granulation and epithelisation phase of healing. This is new treatment method in which the indication
criteria for use must be precisely designated.
Key words
diabetic foot - enriched plasma - wet wound dressing
34
Stem Cell Therapy for NO-Critical Limb Ischemia and Diabetic Foot
Václav Procházka
University Hospital Ostrava: Czech Republic
Toto téma bylo řešeno a jeho výsledky vznikly v rámci projektu SulgeliX TA02011313, který byl řešen s finanční
podporou TA ČR program ALFA.
History v NO-CLI stem cell therapy:
In 1997 Asahara identified a class of bone-marrow derived progenitor cells that contribute to angiogenesis in
ischemic tissue. The first clinical trial of autologous cell therapy in patients with CLI was published in 2002 by
Tateishi-Yuyama, et al., who reported that patients treated with mononuclear cells isolated from bone marrow
demonstrated improved hemodynamic measurements. Since this promising start, researchers have accumulated
a decade of experience in the use of autologous cell therapy for NO-CLI with clinical trials progressing from retrospective case series to prospective studies and finally to several recent randomized controlled trials (RCTs).
Randomized controlled trials of autologous cell therapy in NO-CLI
Author
Year
N
Total
N
Treated
N
Control
Source
Concentration Etiology
technique
Follow up
(mo)
Benoit
2011
48
34
14
BM
POC
ASO
6
Lu
2011
82
41
41
BM
Ficoll
ASO
6
Powell
2011
46
32
14
BM-Ex
Cell culture
ASO
6
Walter
2011
40
19
21
BM
Ficoll
ASO/TAO
3
Prochazka
2010
96
42
54
BM
POC
ASO
4
Arai
2006
25
13
12
BM
Cell separator
ASO
1
Huang
2005
28
14
14
PB
Cell separator
ASO
3
Totals:
365
195
170
BM = bone marrow; BM-Ex = bone marrow cells ex vivo culture expanded; PB = peripheral blood; ASO = atherosclerosis; TAO = thromboangiitis obliterans; NR = not recorded; POC = point of care centrifugation
Methodology of stem cells processing:
Most autologous cell therapy protocols use bone marrow mononuclear cells (BMMNCs). Cell separators are automated machines, operated by a specialized technician or hematologist, which can isolate mononuclear cells from
bone marrow aspirate (BMA). The Harvest SmartPReP device is a point of care, automated centrifuge system which
processes the bone marrow aspirate with minimal manipulation, never removing the cells from their native plasma
environment. Operation of the device does not require specialized personnel or transport of samples outside of
the procedure room, which minimizes error and allows the entire process to be performed under the total supervision of the treating physician. The processing time is roughly 15 minutes, which allows bone marrow harvesting,
processing, and delivery of autologous cell therapy to be completed during a single trip to the procedure room.
Furthermore, the Harvest SmartPReP device prepares autologous cell concentrate from 240 mL of bone marrow
aspirate, a volume which may be harvested without need for general anesthesia and is low enough to limit hemodynamic adverse events.
NO-CLI stem cell application study:
The aim of our study was to prevent major limb amputation (MLA) in this group of patients using a local application of autologous bone marrow stem cells concentrate. A total of 96 patients with CLI and foot ulcer (FU) were
randomized into Group I and II. Patients in Group I, n=42 (36 males, 6 females, 66.2 ± 10.6 years) underwent local
treatment with ABMSC while those in Group II, n=54 (control, 42 males, 12 females, 64.1 ± 8.6 years) received standard medical care. The frequency of major limb amputation in Group I and II was 21% and 44% within the 120 days
35
of follow up, respectively (p<0.05). Only in salvaged limbs of Group I both Toe pressure and Toe brachial index increased (from 22.66 ± 5.32 to 25.63 ± 4.75 mmHg and from 0.14 ± 0.03 to 0.17 ± 0.03, respectively, Mean ± SEM).
This difference was statistically significant (p<0.040).
We conclude ABMSC therapy results in 79% limb salvage in patients suffering from CLI and FU. In the remaining
21% lymphopenia and thrombocytopenia were identified as potential causative factors suggesting that at least
a partial correction with platelet supplementation may be beneficial.
Most important point
The CD34+ cell counts in bone marrow concentrate (BMC) decreased (correlation, p=0.024) with age, even though
there was no correlation between age and healing. An unexpected finding was made of relative, bone marrow lymphopenia in the initial bone marrow concentrates in patients who failed ABMSC therapy (21% of MLA).
Most promising thing recently discovered
Stromal vascular fraction from fat tissue lipoaspirate play important role in preventing MLA (Major limb amputation) in 75% of patients even with renal insuficiency and poor bonne marrow aspirate. It may be additional tool for
NO-CLI patients treatment.
Most concerning thing recently discovered
SVF-ASC may have additional role in metabolic, imunomodulation and imunosupressive effect in patients with
T2DM and critical limb ischemia for wound healing, glyc HbAlc and and other metabolic markers.
Some interesting point
Mesenchymal stem cells may be described as pericytic cells and have a consequences similar to “drug store” with
multipotent effects in different diseases.
36
Cell Therapy in No-option Critical Limb Ischemia – Comparison of Therapeutic
Methods and Predictors of Therapeutic Effect
Madaric J1,2, Klepanec A1,2, Altaner C3, Valachovicova M1, Mistrik M4, Necpal R2, Vulev I1,2.
1
Slovak Medical University, 2National Institute of Cardiovascular Disease, 3Institute of Experimental Oncology, Slovak
Academy of Science, 4Clinic of Hematology and Transfusiology, Faculty Hospital, Bratislava, Slovakia
Background
The aim of our study was to assess the effects of intramuscular (IM) and intraarterial (IA) bone marrow cells (BMCs)
application in patients (pts) with “no-option“ critical limb ischemia (CLI), and to address factors associated with the
therapeutic benefit of cellular therapy.
Methods
Seventy pts (age 64±11 years, M:F 61:9) with advanced CLI (Rutherford category 5,6) not eligible for revascularization were randomized to treatment with 40ml of bone marrow mononuclear cells (SmartPreP2 System) either using local intramuscular (n=36) or selective intra-arterial infusion (n=34). The primary end-point was limb salvage at
12-months follow-up. In subgroup of 41 pts, biological properties of mesenchymal stem cells (MSCs) were characterized according to their expression of cell surface markers and secretion of 27 cytokines, chemokines and growth
factors. Pts with limb salvage and wound healing were considered as responders to BMCs therapy.
Results
The limb salvage was present in 77% (48/62 pts) at 12-months, eight pts died unrelated to stem cells therapy at
1-year follow-up (11%). In responders, a significant improvement in tcpO2, pain scale, quality of life, and Rutherford
category was noted at 6 months persisting up to 12-months. There were no differences in IM versus IA application
after 6 as well as 12-months in all observed parameters. In the subgroup analysis of 41 pts, responders (27 pts) were
characterized by higher bone-marrow CD34+ cell counts (CD34+ 29±15×10^6 vs 17±12×10^6, p<0.05) despite a
similar number of total nucleated cells (4.3±1.4×10^9 vs 4.1±1.2×10^9, p=0.66), by lower C-reactive protein levels
(18±28 vs 100±96 mg/L, p<0.05) as well as serum leukocytes (8.3±2.1×10^9/L vs 12.3±4.5×10^9/L, p<0.05) as compared with non-responders (14 pts). By multivariate analysis the number of administrated CD34+ cells >20x10^6
emerged as an independent predictor of clinical benefit (p=0.03). In addition, expression of cell markers CD44 and
CD90 in MSCs of responders was significantly higher as compared with non-responders (p<0.02). Secretome of
responders revealed also significantly higher secretion levels of IL-4 (p<0.05), IL-6 (p<0.01), and MIP-1b (p<0.03)
compared with non-responders.
Conclusion
Both IM and IA cells delivery are effective and comparable methods of therapy of patients with NO-CLI. A higher
concentration of CD34+ cells, in parallel with higher concentration of MSCs is associated with better clinical outcome. Synergic effect of endothelial progenitors and MSCs, mediated by the paracrine effects appears to play
crucial role in complex mechanism of cell therapy.
37
Cell therapy in No-option CLI: state of the art and long-term results
Berthold Amann
Critical limb ischemia (CLI) is the most advanced stage of PAD and has a high mortality and amputation rate. Wherever possible, the attempt to improve the revascularization of the leg arterial blood should be carried out. However, revascularization either with a surgical bypass or an endovascular procedure is primarily not or not any more
possible in 20-30 % of CLI patients. These patients are called no-option CLI patients (NO-CLI) and have a grim
prognosis, mostly ending with leg amputation. In Germany, about 25.000 major amputations are performed yearly
due to CLI, about 100.000 in the US:
In the last 15 years, the concept of a natural bypass has been developed. In short, basic science has shown that
the growth of collateral arteries which can replace the transport function of a native occluded artery, is an active
process directed by pericollateral monocytic cells which immigrate from the bone marrow. In the setting of ischemia, bone marrow cells are recruited, travel along a cytokine gradient to the ischemic area/the occluded artery
and transmigrate into the pericollateral space. Her, they secrete cytokines, proteases and hormones which induce
collateral artery growth which optimally restores blood flow in the ischemic area. This physiologic repair process
however does not work in i.e. people with diabetes or advanced atherosclerosis. Here, the bone marrow response
to ischemia is blunted (“diabetic mobilopathy”, Di Persio 2011), and collateral growth is not sufficient. The goal
of cell therapy is to bring bone marrow cells into the ischemic region in order to induce collateral artery growth.
From 1994 onwards, animal studies with autologous bone marrow cells (BMC)or cultured/expanded subfractions
of bone marrow cells demonstrated the basic ability of locally implanted cells to stimulate collateral artery growth
in a clinically meaningful way resulting in less necrosis or gangrene and increased exercise capacity. The first randomized clinical trial ( TACT – Study, Lancet 2002) on safety and efficacy of autologous bone marrow cell therapy in
patients with peripheral arterial occlusive disease showed in addition to the practicality and safe application of the
method the improvement of hemodynamic parameters, better wound healing and pain reduction. Following this
publication, in a number of case or case control series , an increase of hemodynamic surrogate parameters ( ABI,
TBI , oxygen tension ) were confirmed, as well as a reduction of pain , along with an improved quality of life. Since
2012, several meta-analyses have been published, all favoring cell therapy over placebo. The safety record is impeccable- with more than 1200 patients published, there was a zero-procedure related mortality and less than 5%
minor morbidity. Limb salvage rates are between 45 and 65% depending on the collective studied. The application
of cell therapy in diabetic foot/peripheral artery disease will be demonstrated, with case reports and case series as
well as results from a randomized multicentric study in Germany. Furthermore, own long term results up to 6 years
and the long term results from literature will be discussed.
38
Autologous bone marrow stem cell: a possible solutions for end stage
ischemic cardiomyopathy
Eugenio Caradonna, Carlo Maria De Filippo
Fondazione di Ricerca e Cura Giovanni Paolo II (Università Cattolica del Sacro Cuore)
Implantation of bone marrow stem cell (BMSC) in the myocardium is feasible and safe. Clinical outcome have been
controversial 1.
Isolated BMSC, mainly CD34+ CD133+, have been utilized in almost all the studies.
The process to repair the ischemic myocardium is complex and involves cardiac stem cells, BMSC, cytokines and
platelets2.
Autologous bone marrow aspirate concentrate (BMAC), obtained by using a point of care device, has been infused
intracoronary in patients with positive results 3. BMAC consists of a heterogeneous cell population, including hematopoietic, mesenchymal, progenitor cells as well as granulocytes and platelets. BMAC has the full complement
of the nucleated cellular niche suspended in its natural plasma environment. These components are involved in the
repair of the ischemic event. We report 11 patients with ischemic congestive heart failure and BMAC implantation.
Five patients untreatable coronary artery disease (CAD) underwent BMAC implantation directly into the myocardium via left anterior thoracotomy. Six patients with ischemic cardiomyopathy, received BMAC in the area of viable
myocardium and no graftable vessels during the operation of coronary artery by pass (CABG).
Methods
Eleven patients with ischemic cardiomyopathy, underwent autologous fresh BMAC implantation Six pts received
BMAC during operation for cabg in the zone with viable myocardium and absence of suitable coronary artery
(Group I). Five pts. were treated with BMAC via left anterior thoracotomy (Group II). Age of the pts ranged between
56 and 75 yrs. EF% was between 15-57%.
All patients were considered inoperable due to poor quality of the coronary arteries by our internal validation system as well as by independent Institutions .
The Catholic University Ethical Committee approved the treatment. Informed Consent was obtained by all participants.
Dobutamine echocardiography and MRI were utilized to evaluate the presence of viable myocardium. Two patients
with ICD underwent single photo emission tomography (SPET). The segments involved were anterior, antero-lateral and postero lateral.
Surgical Technique
Under general anesthesia, 120 ml of BM , aspirated from the posterior iliac crest, were processed to produce 20
ml of BMAC using a point- of-care system (Harvest BMAC System; Harvest Technologies GmbH, Munich, Germany)
according to the manufacturer’s instructions. One ml of BM and 1 ml of BMAC were sent to the laboratory for cytometric analysis (Beckman Coulter Navios). During the 15 minute processing period, the patient was repositioned
to a prone position.
Group I: during routine cabg, before to remove the aortic occlusion, 20 ml of BMAC were injected in the target area.
Group II: through a small anterior thoracotomy, BMAC was implanted into the myocardium via 20 injections of 1 ml
each (22 gauge needle). The segments involved were the anterior and lateral wall of the left ventricle.
Perioperative care
Cardiac index was measured on an hourly base. Continuous electrocardiographic monitoring with automatic arrhythmia detection was maintained for 7 days post surgery. Echocardiography was performed inter-operatively
and at one week.
Follow-up visit was conducted at 1, 6 and 12 months. All patients underwent 24-hour Holter recording, echocardiography and MRI (2 pt. SPET).
Results
BM aspirate and BMAC of goup II are expressed in the following panel Table 1. Of notie we observed an increase in
the circulating stem cells the day after the operation. For Group I the data are similar.
39
Table 1 Platelets and stem cells concentration :Fist line Bone marrow , second line BMAC , third line preoperative
peripheral blood , fourth line post operative peripheral blood.
Group II.
Platelets
CD34
CD34
CD133
CD133
CD117
CD117
(c-kit)
(c-kit)
CD309
CD309
%
cell x106 %
ml
cell x 106 %
ml
cell x 106 %
ml
PLT 99
1,778%
0,25
0,148%
0,021
0,958%
0,140
0,014%
NC
PLT 401
1,970%
1,31
0,156%
0,104
1,286%
0,850
0,019%
NC
PLT 262
0,190%
0,012
0,042%
0,002
0,152%
0,009
0,015%
NC
PLT 252
0,140%
0,011
0,037%
0,002
0,136%
0,009
0,008%
NC
PLT 109
0,664%
0,05
0,096%
0,008
0,380%
0,030
0,010%
NC
PLT 641
0,879%
0,36
0,043%
0,018
0,500%
0,200
0,027%
NC
PLT 272
0,120%
0,006
0,013%
0,001
0,280%
0,015
0,020%
NC
PLT 248
0,330%
0,019
0,068%
0,004
0,119%
0,007
0,011%
NC
PLT 118
1,02%
0,170
0,23%
0,038
0,15%
0,025
0,021%
NC
PLT 390
1,19%
0,650
0,30%
0,160
0,18%
0,099
0,029%
NC
PLT 292
0,129%
0,005
0,023%
0,001
0,250%
0,015
0,020%
NC
PLT 267
0,326%
0,015
0,056%
0,003
0,126%
0,007
0,011%
NC
PLT 121
2,05%
0,690
0,12%
0,080
2,68%
0,810
0,04%
NC
PLT 43
2,30%
0,990
0,13%
0,110
2,61%
1,400
0,010%
NC
PLT 252
0,130%
0,009
0,016%
0,001
0,280%
0,015
0,020%
NC
PLT 266
0,200%
0,015
0,048%
0,004
0,119%
0,007
0,011%
NC
PLT 112
1,130%
0,220
0,130%
0,020
1,050%
0,200
0,007%
NC
PLT 487
1,02%
0,850
0,10%
0,080
0,92%
0,770
0,01%
NC
PLT 158
0,107%
0,006
0,063%
0,004
0,021%
0,001
0,008%
NC
PLT 142
0,293%
0,014
0,355%
0,018
0,015%
0,001
0,129%
NC
Group II
Immediately after the injections, the cardiac index spontaneously increased. All the patients were discharged on
the 7th post operative day. Arrhythmias were not recorded.
At six months follow-up 4 patients were in class NYHA I and 1 in class II, EF increased (mean increase 6%)
Echocardiography and MRI showed positive remodeling of the left ventricle (fig. 2). Late enhancement reduction
(LE) (25% vs 50%) was present in the medial e basal segments of two pts. where BMAC was injected. Three have
completed 1 yy. follow-up and are in NYHA I.
Group I
All patients had an uneventful postoperative course. At a mean follow up of two year they are in NYHA class I. Positive remodeling of the left ventricle was observed in all patients.
Discussion
BMSCs have been used in ischemic heart failure with limited positive results1.
A single population of cells was delivered in almost all the studies. BMAC contains the majority of the components
for the repair of the ischemic damage.
The importance of the cooperation between different cell populations has been addressed by Williams et. al. 4. Cytokines are triggered by the ischemic events and play a major role in the interactions between cells in the process
to restore the damaged myocardium and in the evolution of hibernation toward apoptosis.
40
Platelets produce several factors as VEGF, SDF-1, that are important for homing, differentiation of endothelial progenitor cell toward endothelial cell and mobilization of cardiac stem cells for myocardial repair 5.
Patients with ischemic cardiomyopathy and not operable CAD treated with BMAC (Group II), have had a substantial improvement in EF, NYHA class, left ventricle positive remodeling and in the quality of life). Stem cells were
increased in the early post operative period, suggesting a positive effect on the bone marrow-cardiac axis.
Patients with cabg and BMAC (Group II) haven’t had complications and are in NYHA class I.
This results prove that BMAC implantation is safe. Further studies are needed to confirm the positive improvement
obtained in the remodeling of the heart and in the quality of life of the patients
Bibliography
1. Jeevanantham V, Butler M, Saad A, Abdel-Latif A, Zuba-Surma EK, Dawn B. Adult bone marrow cell therapy improves survival and induces long-term improvement in cardiac parameters: a systematic review and meta-analysis.
Circulation. 2012 Jul 31;126(5):551–68.
2. Maltais S, Perrault LP, Ly HQ. The bone marrow–cardiac axis: role of endothelial progenitor cells in heart failure.
European Journal of Cardio-Thoracic Surgery. 2011 Mar;39(3):368–74.
3. Turan RG, Bozdag-Turan I, Ortak J, Akin I, Kische S, Schneider H, et al. Improved Mobilization of the CD34 +and
CD133 +Bone Marrow-Derived Circulating Progenitor Cells by Freshly Isolated Intracoronary Bone Marrow Cell
Transplantation in Patients with Ischemic Heart Disease. Stem Cells and Development. 2011 Sep;20(9):1491–501.
4. Williams ARA, Hatzistergos KEK, Addicott BB, McCall FF, Carvalho DD, Suncion VV, et al. Enhanced Effect of Combining Human Cardiac Stem Cells and Bone Marrow Mesenchymal Stem Cells to Reduce Infarct Size and to Restore
Cardiac Function After Myocardial Infarction. Circulation . 2013 Jan 14;127(2):213–23.
5. Tang J-M, Wang J-N, Zhang L, Zheng F, Yang J-Y, Kong X, et al. VEGF/SDF-1 promotes cardiac stem cell mobilization and myocardial repair in the infarcted heart. Cardiovasc. Res. 91:402–11.
41
The enhancement of T cell-mediated immune responses through the use of
beta lactams.
Frida Grynspan
Stem Cell Medicine Ltd, Jerusalem, Israel
Remarkable advances have been made in understanding the mechanisms of action of T cells in cancer and autoimmune disease. Stem Cell Medicine Ltd believes that the clinical outcomes of cellular therapies can be improved
through the combination with traditional pharmaceutical products.
One such approach is the use of beta-lactams in the preparation of T-cell populations used in the treatment of
tumors. Results have shown that beta lactams inhibit tumor growth in a T cell lymphoma mice model (RMA). In
addition beta lactams are able to inhibit CD4+ differentiation to Th-2 through the inhibition of STAT6 and 18 Nf-κB
related genes (Mor F & Cohen IR 2013). Further, beta lactams were shown to down-regulate 11 TGF-β related genes.
TGF-β is known to induce CD4+ T cell differentiation to Treg (Wan YY 2008). Both Th2 cells and Treg are inhibitors
of the Th1 response.
These results indicate that beta lactams act through the suppression of a number of genes to affect CD4+ cell
differentiation and provide a clear evidence of the potential of these compounds to act as anti-cancer agents by
enhancing Th1 immunity and suppressing CD4+ cell differentiation to Th2 and Treg.
42
Factors Influencing Yield and Composition of Regenerative Cell Preparations
Eckhard Alt, Michael Coleman
InGeneron, Inc, Houston, TX, USA, InGeneron, GmbH, Munich, Germany
Cell therapies utilizing autologous regenerative cells prepared at point-of care and administered within the same
procedure are used with increasing frequency in a wide range of indications including aesthetic and reconstructive surgery, heart and vascular disease, osteoarthritis, orthopedics, and non-healing wounds. Unlike cell therapies
comprised of cultured cells and produced in large batches as biopharmaceuticals these personalized cell preparations may vary based on patient and methodological factors. Patient factors such as age, lifestyle, disease status,
and concomitant medications are known to influence characteristics of the cell preparation, but these factors may
not be easily altered. However, methodological factors under control of the clinician including tissue source and
anatomical location, and technologies utilized for tissue acquisition and cell isolation may have dramatic effects
on the final cell preparation. Aronowitz and coworkers (Plastic and Reconstructive Surgery, 2013, 132(6):932-939)
recently compared four in-clinic systems for isolation of adipose derived cells and found significant differences
between the systems in cell yield, residual collagenase activity, and in the proportion of colony forming fibroblasts.
This presentation will summarize results reported in the scientific literature as well as our own results for preparation of adipose tissue and umbilical cord matrix derived regenerative cells.
43
Regenerative Medicine and Cell Technologies in Stem Cells Bank Pokrovsky,
Russia
V Bagaeva, A Aiezenshtadt, A Smolyaninov
Stem cells bank Pokrovsky, Sankt-Petersburg, Russia
Regenerative medicine is the „process of replacing or regenerating human cells, tissues or organs to restore or
establish normal function“. In our laboratory we consider on two directions:
1. Mesenchymal stem cells as regenerative technology basis
2. Fibroblasts for patients with burn and for cosmetology
Mesenchymal stem cells (MSC) are pluripotent stem cells with fibroblasts like morphology, high proliferative potential and definite immunophenotype: CD34-, CD44+, CD45-, CD90+, CD105+ etc. It can be characterized by capacity to adhesion to culture plastic, differentiation potential to adipose, chondrogenic and osteogenic lines.
MSC possess a wild spectrum of biology active action: immunomodulatory, stimulation of angiogenesis, antiapoptotic and antinecrotic effects etc. So MSC became a most popular sourсe for regenerative and cellular therapy.
There are more than three hundred and half clinical trials based on MSC application in international clinical trials
database. Including application of allogenic MSC. Safety of MSC application isn’t question anymore.
In our laboratory we create bank of certified MSC cultures from different source: bone marrow, adipose tissue, cord
blood and cord. We pay especial attention to quality control of cultures.
The most interesting for us fields of MSC application are autoimmune diseases (multiple sclerosis, diabetis, Chrone
disease), regenerative therapy (toxic hepatitis) and traumatology.
In this field we carry out limited clinical trials. Also we investigate influence of MSC on allergic reactions. Here we
at the stage of in vitro studies. And we’ve shown following effects after coculture of MSC and allergen activated
lymphoceted: on the one hand decreasing of level of main trigger of allergic reaction – IL4, relative number of activated T cells and level of IgE. And on the other hand we observed increasing of anti-inflammatory cytokine IL10
and relative number of regulatory T cells. So after model of stopping of allergic reaction we are planning preclinical and limited clinical trials of application MSC for therapy resistance atopic asthma. Also we have good result of
limited clinical trials of MSC in traumatology for difficult bone fracture, including in geriatric patients. Also we carry
out limited clinical trials of autological MSC transplantation for arthritis and arthrosis treatment.
The second big field of our work – is transplantation of allogenic fibroblasts for patient with extensive burns. All
fibroblasts cultures passed strict quality controls and certified. We developed good for use dosage form based on
fibroblasts culture in hydroxyethyl cellulose gel.
44
Bioartificial Replacements of Blood Vessels – a Review
Lucie Bačáková
Institute of Physiology, Academy of Sciences of the Czech Republic, Videnska 1083, 142 20 Prague 4 - Krc, Czech Republic;
E-mail: [email protected]
Bioartificial tissue replacements comprise two main components: artificial material and cells. The artificial material
acts as a carrier for the cells since they are generally anchorage-dependent. In advanced tissue replacements, the
material component should not only to be passively tolerated by the cells but it should actively promote the adhesion, growth, differentiation, phenotypic maturation and other cell functions in a controllable manner. In other
words, the material component should act as an analogue of the native extracellular matrix.
In the first part of our research, we concentrated on the innovation of synthetic polymeric vascular prostheses
used in the current clinical practice. These prostheses contain only the material component, and originally they
have not been designed for the adhesion and growth of cells, particularly endothelial cells, although it is known
that the confluent and mature endothelial cell layer is the best prevention of the prosthesis restenosis and failure.
Therefore, the inner surface of knitted polyethylene terephtalate protheses was modified by special assemblies of
extracellular matrix molecules (collagen, fibronectin) and particularly fibrin, because fibrinogen could be isolated
in considerable amount from the patient´s own blood. These assemblies improved the cell-matrix and cell-cell adhesion of vascular endothelial cells, their subsequent growth and phenotypic maturation, and also their resistance
to laminar shear stress generated by a perfusion cultivation system. In addition, the modified prostheses proved as
functional when implanted in vivo, namely into minipigs.
In the second part of our research, we focused on the creation of a completely new bioartificial vascular tissue. For
this purpose, a polylactide-based biodegradable material carrier was applied. On the surface of these scaffolds,
RGD-containing oligopeptides, i.e. ECM-derived ligands for integrin adhesion receptors on cells, were tethered
through polyethylene oxide (PEO) chains. The concentration of these ligands on the material surface regulated the
number of initially adhered endothelial and vascular smooth muscle cells (VSMC), the size of their spreading area
and their proliferation activity. For example, on surfaces where the 5% of the PEO chains were functionalized with
the RGD-oligopeptides, the VSMC adhered in lower number, but their spreading area was larger than on surfaces
with 20% of PEO-RGD. On the other hand, the cell proliferation on surfaces with the higher RGD concentration was
faster.
It can be concluded that both tested material types supported the adhesion and growth of vascular endothelial
and smooth muscle cells, and thus they are suitable for the reconstruction of tunica intima and tunica media on
vascular prostheses. Materials functionalized with adhesion oligopeptides enable adhesion and growth of cells in
a controllable manner.
Supported by the Grant Agency of the CR (grants No. P108/11/1857 and P108/10/1106).
45
Aortic Heart Valve Replacements
Elena Filova1, Lubica Stankova1, Adam Eckhardt1, Hynek Chlup2, Lukas Horny2, Eva Gultova2, Jan Vesely2,
Frantisek Straka1,3, Lenka Šimčíková1, Jana Musílková1, Jaroslav Masin3, Yuan-Tsan Tseng4, Jan Pirk3, and Lucie
Bacakova1
1
Institute of Physiology, Academy of Sciences of the Czech Republic, v.v.i., Prague, Czech Republic, 2Faculty of Mechanical
Engineering, Czech Technical University in Prague, Czech Republic, 3Institute for Clinical and Experimental Medicine, Prague, Czech Republic 4Biomaterials Group, Department of Materials, University of Oxford, Oxford, UK
A considerable amount of patients need heart valve replacements worldwide. Mechanical prostheses, based on
carbon, metallic and polymeric components, require permanent anticoagulation treatment, and their usage often
leads to adverse reactions, e.g. thrombo-embolic complications and endocarditis. Xenogenous and allogenous biological prostheses are associated with immune reaction, thrombosis and degeneration, and thus they have a high
rate of reoperation. Biological prostheses of autologous origin, such as pulmonary autografts, often burden the
patient with a complicated surgery and risk of reoperation. New approaches involve development of bioartificial
heart valve prostheses using scaffolds seeded with autologous cells in bioreactor, modification of biological tissues
such as bovine or human pericardium with various cross-linking agents followed by seeding them with patient`s
cells. The newly prepared bioartificial heart valve prostheses should be biocompatible, durable, endowed with
appropriate mechanical properties and able to grow with a child. Chemical treatment of pericardium of bovine
origin has been studied extensively. We evaluated a collagen scaffold and native human pericardium as a potential
autologous tissue source in dynamic experiments. In addition, human pericardium was treated with various crosslinking agents and the effectiveness of cross-linking was assessed.
Supported by the Grant Agency of the CR, grants No. P108/11/1857, P108/12/1168, P108/12/G108, P108/10/1106,
and by the Ministry of Health of the Czech Republic, grant No. NT11270 – 4/2010.
46
Clinimacs Prodigy in Regenerative Medicine
Ivan Hutňan
Miltenyi Biotec, Slovensko
Cellular therapies are being investigated for an increasing range of applications. Miltenyi Biotec has developed an
integrated cell-processing system to perform all steps from sample preparation to final formulation of the cellular
product Once safety and efficacy of a cell therapy product have been shown within a clinical trial program, successful commercialization may often be hampered by complex and costly production processes..
The CliniMACS Prodigy with its integrated fluid transfer, centrifugation, incubation and magnetic separation capabilities, has been designed for fully automated cell processing and cell culture applications. This GMP-compliant
device is designed to be used with specialized CliniMACS Prodigy Tubing Sets which allow for a sterile and functionally closed fluid path.
47
Legislativní rámec oboru Regenerativní medicína v ČR a EU
Národní Centrum Tkání a Buněk a.s., Brno
Regenerativní medicína je zcela novým oborem, jehož historie se začala psát na konci 20. století.
Evropská unie (a následně i Česká republika) trend rychle zaznamenala a svými aktivitami podporuje tuto oblast
finančně, politicky i různými vzdělávacími činnostmi.
Vzhledem k tomu, že Regenerativní medicína v sobě spojuje dvě rozsáhlé oblasti, a to farmaceutickou problematiku a problematiku týkající se použití lidských tkání a buněk, vyvstala potřeba vymezit legislativní rámec celého
oboru.
Přednáška se bude věnována vývoji právních předpisů regulujících Regenerativní medicínu, současnému stavu
i odlišnostmi příslušné legislativy napříč státy Evropské unie.
The Legislative Framework for Regenerative Medicine in the Czech Republic
and the EU
Eva Matějková
National Cell and Tissue Centre, Brno, Czech Republic
Regenerative Medicine is a brand new field of study which originated in the late 20th century.
The European Union (and subsequently also the Czech Republic) became quickly aware of the trend and has been
supporting this area with its financial, political and various educational activities.
Because Regenerative Medicine encompasses two extensive areas, i.e., pharmaceutical issues and issues concerning the use of human tissues and cells, the need to define the legislative framework of the entire field arose.
This lecture will focus on the development of legal regulations governing Regenerative Medicine, the current situation and differences between the corresponding laws across the individual states of the European Union.
48
Transplantace allogenního štěpu sterna k uzávěru post-sternotomických
defektů hrudní stěny – výsledky 4 let úspěšné mezioborové spolupráce
Martin Kaláb
Kardiochirurgická klinika Fakultní nemocnice Olomouc a Lékařská fakulta Univerzity Palackého Olomouc
Dehiscence sternotomie se vznikem rozsáhlého defektu hrudní stěny představuje život ohrožující komplikaci původně úspěšného primárního kardiochirurgického výkonu. Mortalita tohoto závažného stavu obvykle dosahuje až 70 %.
Moderním způsobem léčby sternálních dehiscencí je použití AO dlahové osteosyntézy. V případech ztrátových
defektů hrudní stěny je však tato metoda zatížena rizikem selhání vlivem destrukce nedostatečně ukotvených dlah.
Inspirováni zkušenostmi ortopedické chirurgie jsme se rozhodli provádět náhrady těchto defektů pomocí allogenního kostního štěpu sterna. Ve spolupráci s Národním centrem tkání a buněk se podařilo vyvinout zcela novou
a ojedinělou operační techniku. Ve sdělení je popsán její zrod, vývoj a také zkušenosti praktického použití za období 4 let vzájemně přínosné mezioborové spolupráce.
Transplantation of allogeneic sternal bone graft for closure of post sternotomy chest wall defects – results of four years of successful interdisciplinary
collaboration
Martin Kaláb
Department of Cardiac Surgery University Hospital and Faculty of Medicine Palacky University, Olomouc, Czech Republic
Dehiscence of the sternotomy resulting in a large defect of the thoracic wall represents a life-threatening complication of an originally successful primary cardiac surgery procedure. Mortality rate of this serious condition is usually
up to 70%.
The use of AO plate osteosynthesis represents a modern approach to treatment of sternal dehiscences. In the case
of chest wall loss defects, this method brings, however, a risk of failure due to destruction of insufficiently anchored
plates.
Inspired by orthopedic surgery experience, we have decided to repair these defects using sternal allogeneic grafts.
In cooperation with the National Cell and Tissue Center, we have succeeded in developing a completely novel and
rare surgical technique. Its origin, development, and also practical use experience gained during the 4-year period
of mutually beneficial interdisciplinary cooperation, are described in the communication.
49
Skin Banking - Current Products and Future Developments
C.D. Richters
Euro Tissue Bank, division Euro Skin Bank, Beverwijk, The Netherlands
Allogeneic skin grafts are still important and even life saving for the treatment of severely burnt patients. Allogeneic skin is used as a temporary dressing, for final wound closure autologous skin is needed. Several methods have
been developed to store the allogeneic skin until use, most often used are cryo-preservation and storage in high
concentrations of glycerol (85%).
With the clinical protocols now it is possible to save patients with large burns but the remaining scars can cause
many difficulties, ranging from scar contraction to psychological disorders. The development of methods to decellularize human skin resulted in acellular dermal tissue for the treatment of deep burns or other full thickness
wounds. Since all donor cells are removed, the remaining collagen-elastin matrix can be used as an implant, covered with a thin autologous split skin. Rejection will not take place and the donor dermal tissue will serve as a matrix for host fibroblast and blood vessels. Slowly, the donor collagen and elastin fibres will be replaced, leading to
better scar quality. We have used a method with low concentrations of NaOH to decellularize allogeneic skin. This
acellular dermis (Glyaderm) has been clinically investigated since 2005. The results show significant improvement
of the elasticity of the scar, 1 year after the application of Glyaderm. Long term results up to 8 years show further
improvement of scar quality. In combination with negative pressure wound therapy, Glyaderm can also be used
for chronic wound treatment.
Wound closure can be difficult in patients with extended wounds. Several techniques have been developed to expand the harvested autologous skin, such as Meek-Wall islands. The results of these techniques with respect to scar
quality can be disappointing, probably caused by the longer period till wound closure is achieved. To speed up reepithelisation, cultured keratinocytes can be added to the wound, either allogeneic or autologous. Unfortunately,
these techniques are expensive and the expansion of autologous cells in vitro takes often 2–3 weeks. Attempts
to use foetal skin cells for this purpose have been made but ethical problems may arise. A future possibility may
be the development of a living skin substitute constructed during operation of the patient, comprising both the
epidermis and a dermal matrix populated with fibroblasts and endothelial cells.
50
The use of modern technologies in processing of human tissue products for
clinical use
Ján Karkoška
National Cell and Tissue Centre, Brno, Czech Republic
Objective:
Different methods are used for processing of tissues using different technologies all around the world. Since the
adoption of Czech national regulation regarding human tissues and cells - Act 296/2008 Coll. (tissue and cells act)
and decree 422/2008 Coll. the situation in the Czech Republic has changed radically. It was necessary to deal with
the fundamental requirements of the new strict legislation, and conditions required by State inspection for drug
control. Author describes development of new technological device intended for processing of human tissues,
based on principles of isolator technology, in which product is hermetically closed and processed in super aseptic
space (class A) and separated from the operators.
Lecture is focused on processing of musculoskeletal tissues which is principally one of the most complex technological problems of musculoskeletal banking. The core problem primarily lies in operations which produce extreme
quantities of particles, critical procedures are cutting and shaping of material using bone cutters, reamers and
flushing technology. These operations distort purity of clean rooms. One way to solve the problem of these operations is based on using of isolator technology.
51
ZDRAVOTNICKÉ
NOVINY
On-line fórum
zdravotnictví
a sociální péče
ODBORNÉ FÓRUM ZDRAVOTNICTVÍ
A SOCIÁLNÍ PÉČE www.zdravky.cz
63rčíslo 5r24. února 2014
ISSN 0044-1996
cena 26 Kč r pro předplatitele 20 Kč
SÚKL vede krizový manažer
www.zdravky.cz
Z OBSAHU
■
Ministr zdravotnictví MUDr. Svatopluk Němeček, MBA, v pondělí 10. února odvolal z funkce šéfa Státního ústavu pro kontrolu léčiv MUDr. Pavla Březovského, MBA. Dočasným řízením
ústavu pověřil PharmDr. Zdeňka Blahutu.
Podle oficiální tiskové zprávy ministerstva zdravotnictví je důvodem odvolání MUDr. Březovského nespokojenost se způsobem řízení SÚKL, zejména v oblasti cenové a úhradové
regulace, nedostatky v dozorových
činnostech a nedostatečná kontrola
nakládání s veřejnými prostředky.
„Dosavadní výkony a styl práce úřadu
se výrazně rozchází s mými požadavky na klíčovou instituci českého zdravotnictví. Ta by měla být pružnější
a pod větší kontrolou státu. Současně
považuji za nešťastné, aby jeden člověk řídil dvě významné instituce zároveň (pozn.
(
red.: P. Březovský je od
prosince r. 2006 ředitelem Koordinačč
ního střediska transplantací, do funkk
ce ředitele SÚKL byl 2. května 2012
jmenován ministrem doc. MUDr. Leošem Hegerem, CSc.). Pavlu Březovskému děkuji a přeji mnoho úspěchů
v příštím působišti,“ uvedl ke svému
rozhodnutí Svatopluk Němeček.
Jako hlavní úkoly dočasného ředitele
ministr stanovil zvýšení efektivity
v oblasti cenové a úhradové regulace
a urychlení správních řízení. Dále důslednou kontrolu vynakládání veřejných prostředků v činnostech SÚKL.
„Největší důraz budu klást na precizní výkon regulace cen a úhrad, která
povede k finančním úsporám pro pacienty a pro systém veřejného zdra-
votního pojištění,“ konkretizoval v tiskové zprávě MUDr. Němeček.
■
První prezentace ředitele
PharmDr. Zdeněk Blahuta uspořádal
den po svém jmenování briefing.
Oznámil, že z titulu pozice krizového
manažera s okamžitou platností provedl personální změny – odvolal náměstka pro odborné činnosti Mgr. Filipa Vrubela, náměstka pro ekonomiku Ing. Petra Noska a náměstka pro
informační technologie Ing. Pavla Veselého. Konkrétní jména lidí, které
přijme do svého týmu, slíbil oznámit
do několika dnů.
Zástupcům médií potvrdil Z. Blahuta
priority svého působení v SÚKL, plynoucí ze zadání ministra. Za další
svůj cíl pak stanovil zintenzivnění
a zkvalitnění dozorových činností,
které ústav provádí. Oznámil, že sdílí
s ministrem zdravotnictví nedůvěru
k některým případům vynakládání
veřejných prostředků v činnosti ústavu, a neprodleně proto zadává provedení forenzního auditu (jak známo,
v SÚKL aktuálně probíhá i ministerr
ská kontrola). Prověřovány budou například některé zakázky v oblasti informačních technologií, dvacetimiliónová zakázka na služby public relations atd. V případech, ve kterých
je to možné, vypisování dalších zaká-
22 × ročně, 590 Kč
www.zdravky.cz
LÉKAŘSKÉ
LISTY
ODBORNÁ PŘÍLOHA
ZDR AVOTNICK ÝCH NOVIN
■
ISSN 0044–1996
24. února 2014 Ʉ www.zdravky.cz
2/2014
4/14
KONGRESOVÝ
LIST
ODBORNÁ PŘÍLOHA
ZDR AVOTNICK ÝCH NOVIN
3. února 2014 Ʉ www.zdravky.cz Ʉ ISSN 0044-1996
1/2014
4 × ročně, 600 Kč
www.urologickelisty.cz
florence
duben 2014 / ročník X
60 Kč, 2,90 € / www.florence.cz
Otorinolaryngologie
XII. ČESKÉ A SLOVENSKÉ
SYMPOZIUM
O ARYTMIÍCH
A KARDIOSTIMULACI
zek nový ředitel prý zatím pozas
PharmDr. Blahuta také sdílí s no
ministrem názor, že předcházejíc
dení SÚKL nedostatečně řešilo
blematiku reexportu léků, a bude
věci věnovat zvýšenou pozornost
prý informace o tom, že dochá
k porušení zákazů vývozu léků, k
vydal ministr MUDr. Martin Ho
MBA. Možnost předcházení rizik
exportu vidí nový šéf SÚKL napří
v tom, že ústav bude sledovat tre
výrobních výpadků a omezení k
Karcinomy v oblasti hlavy a krku | Etiologie | Příznaky a diagnostika | Souvislost s lidským papilomavirem | Chirurgické řešení |
Systémová terapie Ʉ Rinosinusitidy | Současný pohled na diagnostiku a terapii Ʉ Hyperkinetická dysfonie | Současné postupy
diagnostiky a terapie Ʉ OTC v otorinolaryngologii | Volně prodejná léčiva hrají v léčbě onemocnění stále větší roli
■
26.–28. ledna
České Budějovice
s. 8 / Rozhovor
s. 12 / Odborné téma
s. 28 / Výzkumné sdělení
s. 38 / Z konferencí
ŽIVOT S ROZŠTĚPEM
SE ZMĚNIL.
MEDICÍNA POKROČILA
A PACIENTI MAJÍ
PŘÍSTUP K POTŘEBNÝM
INFORMACÍM
PÉČE O DĚTSKÝ
CHRUP
FLUKTUACE
SESTER VE
ZDRAVOTNICKÝCH
ZAŘÍZENÍCH
INSPO 2014
LETOS
PŘILÁKALO
STOVKY
NÁVŠTĚVNÍKŮ
PragueONCO 2014
Článek deníku MF Dnes ze 4. února nadepsaný „Tajná zpráva: Jak mizí miliardy z nemocn
okamžitě vyvolal značnou pozornost – jeho obsahem je totiž poměrně důrazné naznačení
v českých nemocnicích dochází k finančním nekalostem.
22.–24. ledna
časopis
obsahuje
recenzované
články
Praha
ské Vinohrady a ve fakultních nemocnicích v Olom
a v Hradci Králové.
Nejvíce prý na bonusech inkasovala vinohradská nem
nice, jen od dodavatelů kardiostimulátorů a kardiover
to před třemi lety činilo 95 miliónů Kč.
Podle deníku popisuje protokol NKÚ, jak se manažeř
mocnice v letech 2010 a 2011 dohodli se třemi dodávají
firmami. „Nabídli jim bez výběrového řízení rámc
smlouvy, zároveň se s firmami dohodli na vysokých cen
Podle protokolu mnohdy přesně odpovídaly maximál
cenám, které v daném roce slíbila platit VZP. V rámcov
smlouvách byl zároveň stanoven bonus až do výše tří
tin ceny dodávaného materiálu. Rozdíl mezi úhradou
a běžnou cenou na trhu inkasovala nemocnice,“ uvádí
nek. Autor pak sděluje, že protokol NKÚ sice popisuje
krétní smlouvy fakultních nemocnic a přesně vyčís
částky, které v letech 2010 a 2011 na bonusech inkaso
– ale z důvodu ochrany obchodního tajemství nemo
být zveřejněny. „Opatrnost NKÚ při publikaci zřejmě
spěla k tomu, že podivná praxe neskončila,“ konstatu
ODBORNÉ TÉMA
Stomatologie
8. SYMPOZIUM
PRACOVNÍ SKUPINY
PLICNÍ CIRKULACE ČKS
Nová indikace – PDE 5 inhibitory – léčba
erektilní dysfunkce a LUTS
Ureterální stenty – nové možnosti ovlivnění
nežádoucích účinků
Guidelines EAU – zakřivení penisu
17.–18. ledna
Lži bez znalosti systému?
Na tiskové konferenci v pražském Faustově domě o „bonusové problematice“ hovořili (zleva) J. Kunová, D. Jurásková,
1 2013 11. ročník
ODBORN Ý Č A SOPIS PRO OŠE T ŘOVAT EL S T VÍ A OS TAT NÍ ZDR AVOT NICK É PROF E SE
Nemocnice se brání: Obchodn
bonusy nejsou nemravné!
Autor zmíněného článku záležitost shrnuje takto: „Nejde
o složitý trik. Nemocnice nakoupí předražený materiál,
který vyúčtují VZP nebo jiné pojišťovně. Od dodavatelské
firmy si pak vyžádají vysoké bonusy, které často překračují
polovinu fakturované ceny.“ O několik řádků dále pak doplňuje: „Nemocnice však může peníze použít libovolně,
bez kontroly zdravotních pojišťoven. Třeba na právní nebo
poradenské služby, což jsou nejčastější způsoby, jak vyvádět veřejné peníze do soukromých rukou.“
MF Dnes se odvolává na neveřejnou část protokolu, který
sepsal Nejvyšší kontrolní úřad (NKÚ) po kontrole ve čtyřech státních zdravotnických zařízeních – pražských Všeobecné fakultní nemocnici a Fakultní nemocnici Králov-
10 × ročně, 570 Kč
www.fl orence.cz
Důrazná reakce na inkriminovaný článek přišla z Aso
ce nemocnic ČR (AN ČR) ještě v den jeho vydání: „Fak
ní nemocnice odmítají článek vyvolávající představu
popisovaný systém bonusů, který praktikuje většina
mocnic, lze označit za nestandardní nebo dokonce, jak
z článku vydedukovat, za odsouzeníhodný.
Špindlerův Mlýn
www.csnn.eu
www.eonkologie.cz
www.kardiologickarevue.cz
www.csgh.info
T H E J O U R N A L O F T H E C Z E C H A N D S LOVA K O N CO LO G I C A L S O C I E T I E S
͸Ͷͷͺ ͼ; ͷ
K ARDIOLOGICK Á
ČESKÁ A SLOVENSKÁ
revue
KLINICKÁ
ONKOLOGIE
NEUROLOGIE
A NEUROCHIRURGIE
ͷ;ͶͺǦͽ;ͽͺȋȌ
ͷ;ͶͺǦ;Ͷ͹ȋǦȌ
Gastroenterologie
a hepatologie
IN TERNÍ MEDICÍNA

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,ȂǡǡȀǡǡ
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K A R D I O LO G I E
ČASOPIS ČESKÉ NEUROLOGICKÉ SPOLEČNOSTI ČLS JEP, ČESKÉ NEUROCHIRURGICKÉ SPOLEČNOSTI ČLS JEP,
SLOVENSKEJ NEUROLOGICKEJ SPOLOČNOSTI SLS, SLOVENSKEJ NEUROCHIRURGICKEJ SPOLOČNOSTI SLS
A ČESKÉ SPOLEČNOSTI DĚTSKÉ NEUROLOGIE ČLS JEP
Invazivní léčba karotických stenóz
Trvalá kardiostimulace z pohledu nových evropských doporučení roku 2013
Kardiohepatální syndrom u chronického srdečního selhání
Renální denervace – budoucnost nebo zklamání
MINIMONOGRAFIE
Chirurgická léčba hydrocefalu
V. Vybíhal
INTERNÍ MEDICÍNA
Chronické onemocnění ledvin – novinky
Ledviny a gravidita
Akutní poškození ledvin – klasifikace, přehled
PŘEHLEDNÝ REFERÁT
Upozornění na klasifikační, terminologické a obsahové inovace
Mezinárodní klasifikace bolestí hlavy (ICHD-3 beta) pro primární bolesti hlavy
J. Opavský
Z obsahu:
PŮVODNÍ PRÁCE
Chirurgická liečba metastáz a jej vplyv na prognózu u pacientov s metastatickým
kolorektálnym karcinómom
Validita Montrealského kognitivního testu pro detekci mírné kognitivní poruchy
u Parkinsonovy nemoci O. Bezdíček et al
Na MRI založené 3D plánování brachyradioterapie karcinomů děložního hrdla –
naše zkušenosti s použitím uterovaginálního aplikátoru Vienna Ring MR- CT
KRÁTKÉ SDĚLENÍ
Význam elektromyografie v chirurgické rekonstrukci spasticity horní končetiny
I. Čižmář et al
Significant Anti-tumor Effectiveness of Imatinib in C-kit Negative Gastrointestinal
Stromal Tumor – Case Report
KAZUISTIKA
Stiff-Person Syndrome Associated with Myotonic Dystrophy type 2 –
a Case Report E. Ehler et al
2,A
Vydává ČLS JEP. ISSN 1210-7859. ISSN pro on-line přístup 1802-4041.
Indexováno/excerpováno:
Thomson Reuters Web of Knowledge: Journal Citation Report, Web of Science,
Index Copernicus, EMBASE/Excerpta Medica, Bibliographia Medica Čechoslovaca, Scopus
ročník 77 | 110 | 2014 | číslo
|
×͸Ͷͷͺ
1
Vydává ČLS JEP. ISSN 0862-495X. ISSN 1802-5307 on-line přístup
Indexed in MEDLINE/PubMed, EMBASE/Excerpta Medica, EBSCO,
SCOPUS, Bibliographia medica čechoslovaca, Index Copernicus
ročník 27 | 2014 | číslo
1
1
2014 / ročník 16
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