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Specific guidelines on stem cells,
cell therapy & xenotransplantation in the world
(Authors: M. Sneyers and M. Goossens - Last revised:
August 19, 2010
)
Preliminary remark
Although cell therapy or xenotransplantation do not per se involve genetic modifications and are not directly covered by the regulations about genetically modified organisms, these new therapeutic approaches have many points in common with the biosafety issues related to GMOs. Moreover these new medical treatments do not exclude genetic manipulation(s) of the transplanted cells or tissues whether from human or non-human origin.
WHO
- Report of WHO consultation on xenotransplantation, Geneva, Switzerland, 28-30 October, 1997 (WHO/EMC/ZOO/98.2) : gives guidelines to Member states in their approaches to xenotransplantation (PDF)
- Resolution adopted by the 57th World Health Assembly, 22 May 2004 (link)
Unesco
- The use of embryonic stem cells in therapeutic research. Report of the IBC on the Ethical Aspects of Human embryonic stem cell research (BIO-7/GT-1/2 (Rev.3) 6 April 2001) Ethical and social considerations with Recommendations to Member States (PDF)
European Council
- Recommendation 1399 (1999): establishes a moratorium on all xenotransplants in humans (including clinical trials) (link)
- Recommendation Rec(2003)10 of the Committee of Ministers to member states on xenotransplantation and explanatory memorandum (link)
European Union
- EMA scientific guidelines on Cell therapy and tissue engineering (link on EMA web site)
UK (United Kingdom Interim Regulatory Authority
- UKXIRA - ceased to exist from 12 December 2006)
- Publications of UK Xenotransplantation Interim Regulatory Authority (UKXIRA) (Link)
France (Comité Consultatif National
d'Ethique pour les Sciences de la vie et de la santé)
- Opinion on the use of somatic gene therapy procedures. Report (Opinion n°36 - 22/06/1993) (link-list of opinions)
- Opinion on the establishment of collections of human embryo cells and their use for therapeutic or scientific purposes. Report (Opinion n°53 - 11/03/97) (link-list of opinions)
- Ethics and xenotransplantation (Opinion n°61 - 11/06/1999) (link-list of opinions)
Sweden
- The Swedish National Council on Medical Ethics: Statement of opinion on embryonic stem cell research (17/01/2002) (link)
USA
- U.S. Food and Drug Administration - Cellular and Gene therapy Guidance documents (link to web site of FDA)
- U.S. Food and Drug Administration - Xenotransplantation Guidance documents (link to web site of FDA)
- National Bioethics Advisory Commission
- Ethical Issues in Human Stem Cell Research. Volume I, Report and Recommendations of the National Bioethics Advisory Commission (September 1999) (Link-PDF)
- CDC, the infectious Disease Society of America, and the
American Society of Blood and Marrow Transplantation
- Guidelines for Preventing Opportunistic Infections Among Hematopoietic Stem Cell Transplant Recipients, October, 20, 2000 (Link)
- National Institutes of Health (NIH):
- Policy statements and guidelines on federally funded stem cell research (Link)
- The National Academies
- Guidelines for Human Embryonic Stem Cell Research (2005) (Link)
Canada
- Health Canada: NOTICE TO HOSPITALS FROM THE THERAPEUTIC PRODUCTS PROGRAMME The Clinical Use of Viable Animal Cells, Tissues, or Organs to Treat Patients (March 29, 1999) (Link )
- Canadian Institutes of Health Research: Updated guidelines for Human Pluripotent Stem Cell Research (June 7, 2005 - updated June 28, 2006) (Link)
Australia
- National Health and medical research Council: Guidelines for Ethical review of research proposals for human somatic Cell Gene Therapy and related therapies (1/01/2001) (Link) Is meant for Ethical Committees and covers also xenotransplantation.
Scientific Societies
- International Society for Stem Cell Research (ISSCR): Guidelines for the Conduct of Human Embryonic Stem Cell Research(21/12/2006) (Link)
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