Cell and Organ Transplantology. 2016; 4(1):76-81.
Legislative regulation of the banking of umbilical cord blood stem cells, other human cells and tissues and clinical trials with their use in the different countries of the world
Nasadyuk C. M.1, Makhinya A. V.1,2, Shabliy V. A.2, Vyalykh Z. E.3, Zadorozhna V. I.3, Martynenko S. I.2
1Association of Cryobanks of Umbilical Cord Blood, Other Human Cells and Tissues, Kyiv, Ukraine
2Institute of Cell Therapy, Kyiv, Ukraine
3L. V. Gromashevsky State Institute of Epidemiology and Infectious Diseases of NAMS of Ukraine, Kyiv, Ukraine
The article highlights the experience and peculiarities of legislative regulation of umbilical cord blood and tissue banking in the different countries of the world as well as clinical trials with their application. The approaches to licensing and legislative regulation of the business activities of the cord blood banks in Ukraine are also described.
Key words: stem cells, umbilical cord blood, bank of umbilical cord blood, legislative regulation.Full Text PDF
|1. NetCord-FACT International Standards Fifth Edition 70. Available: https://www.factweb.org/forms/store/ProductFormPublic/search?action=1&Product_productNumber=627.|
|2. Arjmand B, Emami-Razavi SH, Larijani B, et al. The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility. Cell Tissue Bank. 2012; 13(4): 587-96.
|3. The Rules Governing Medicinal Products in the European Union of EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-/2008_02_12_introduction_gmp_en.pdf.|
|4. Bosse R, Singhofer-Wowra M, Rosenthal F, et al. Good manufacturing practice production of human stem cells for somatic cell and gene therapy. Stem Cells. 1997; 15(1): 275-80.
|5. FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration. Available: www.factwebsite.org/.|
|6. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells. Available: http://eur-lex.europa.eu/Lex-UriServ/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:en:PDF.|
|7. Leemhuis T, Padley D, Keever-Taylor C, et al. Graft Processing Subcommittee of the Worldwide Network for Blood and Bone Marrow Transplantation (WBMT). Essential requirements for setting up a stem cell processing laboratory. Bone Marrow Transplant. 2014; 49 (8): 1098-105.
|8. FDA Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications. Available: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM187144.pdf.|
|9. Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications. Available: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm388218.htm.|
|10. Good Tissue Practices (GTP) & Reporting. Available: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/GoodTissuePracticesGTPReporting/default.htm.|
|11. AABB Accredited Cord Blood (CB) Facilities. Available: http://www.aabb.org/sa/facilities/celltherapy/Pages/CordBloodAccrFac.aspx.|
|13. Burnett D, Blair C, Haeney MR, et al. Clinical pathology accreditation: standards for the medical laboratory. J Clin Pathol. 2002; 55: 729–33.
|14. Petrou IG, Grognuz A, Hirt-Burri N, et al. Cell therapies for tendons: old cell choice for modern innovation. Swiss Med Wkly. 2014; 7: 144.|
|15. Proceedings of the World Cord Blood Congress v & Innovative Cell Therapies 2015 March 5-8, 2015 – Monaco.|
|16. Overview of the World congress on cord blood and innovative approaches to the treatment of sickle-cell anemia in Monaco on 24-27th october 2013. Cell and Organ Transplantology. 2014; 2(1): 90-4.|
|18. Nasadyuk CM. Cell technologies in reproductology, obstetrics and gynecology. Cell and Organ Transplantology. 2013; 1(1): 56-60.
|19. Nasadyuk CM. Stem Cell Therapy In The Treatment Of Inflammatory Bowel Disease. Gastroenterology&Hepatology: Open Access. 2014; 1(1): 00006.|
|20. Nasadyuk CM. Cell Therapy in Gastroenterology. Cell and Organ Transplantology. 2015; 3(1): 78-81.
|21. Martynenko SI, Makhinya AV, Nasadyuk CM. 11 years of cord blood banking in Ukraine. Cell and Organ Transplantology. 2014; 2(2): 180.|
|22. Nasadyuk CM. Current status and Perspectives of Cord Blood Cryostorage and Clinical Application in Ukraine. Cellular Transplantation and Tissue Engineering. 2011; 6(1): 98-104.|
|23. Nasadyuk CM. Placental stem cells: biological characteristics and approaches to clinical application. Cell and Organ Transplantology. 2014; 2(2): 140-43.
|26. Polchow B, Kebbel K, Schmiedeknecht G, et al. Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks. J Transl Med. 2012; 10: 98.
|27. Matsumoto M. Monica, Dajani Rana, Matthews Kirstin RW. Cord Blood Banking in the Arab World: Current Status and Future Developments. Biol Blood Marrow Transplant. 2015; 21: 1188-94.
|28. Operational Guidelines for Ethics Committees That Review Biomedical Research World Health Organization Geneva 2000. Available: http://www.who.int/tdr/publications/training-guideline-publications/operational-guidelines-ethics-biomedical-research/en/.|
|29. International Declaration on Human Genetic Data: UNESCO, 1997. Available: http://portal.unesco.org/en/ev.php-url_id=17720&url_do=do_topic&url_section=201.html.|
|30. Additional protocol to the convention on human rights and biomedicine concerning biomedical research. 2004. Available: http://www.ub.edu/recerca/Bioetica/doc/Protocol_Biomedical_research.pdf.|
|31. Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine. Available: http://www.eubios.info/EJ123/ej123d.htm.|
|32. Oviedo – Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine. Available: https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=090000168007cf98.|
|33. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes. Available: https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=0900001680084824.|
|34. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Available: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf.|
|35. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Available: http://ec.europa.eu/justice/policies/privacy/docs/95-46-ce/dir1995-46_part1_en.pdf.|
|36. EU Directive 2004/23/EC: towards standards of quality and safety for human tissues and cells in Europe. Available: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32004L0023.|
|37. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Available: http://eur-lex.europa.eu/Lex-UriServ/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:en:PDF.|
|43. Nasadyuk CM, Makhinya AV, Zak SO, et al. Current status and perspectives of cryostorage and clinical application of the umbilical cord blood in Ukraine and in the world. Cell and Organ Transplantology. 2015; 3(2): 208-213.
Usenko OYu, Yakushev AV, Kostylyev MV, Onischenko VF. Effect of transplantation of cord blood total nucleated cells on the manifestation and prognosis of refractory congestive heart failure. Cell and Organ Transplantology. 2016; 4(1):10-13. doi: 10.22494/COT.V4I1.6