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Specific guidelines on stem cells,
cell therapy & xenotransplantation in the world
(Authors: M. Sneyers and M. Goossens - Last revised:
June 10, 2009
)
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 (link-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
- EMEA: CPMP/BWP/41450/98 - Points to Consider on the manufacture and quality control of Human Somatic Cell Therapy Medicinal products (Adopted by CPMP: May 2001) (Link-PDF)
- EMEA: CPMP/1199/02 - Points to consider on Xenogeneic Cell Therapy medicinal Products (Adopted by CPMP: December 2003) (PDF)
- Scientific Committee on Medicinal Products and Medical devices : Opinion on the State of the art concerning xenotransplantation (1/10/2001) (link-PDF)
- European group on Life Sciences, Press release: Statement on
Stem cells research (20/12/2001) (Link)
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
- Guidance For the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products - 10/01/97 (Link)
- Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy - 30/03/98 (Link)
- Guidance for Industry: Public health Issues posed by the use of nonhuman primate Xenografts in humans (April 1999) (Link text - PDF)
- PHS guideline on Infectious disease issues in xenotransplantation (19/01/2001) (Link: text - PDF)
- Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule (18/11/2004) (link to CBER website)
- Guidance for Industry (Final guidance): Source animal, product, preclinical, and clinical issues concerning the use of Xenotransplantation products in humans (April 2003) (Link: text )
- Guidance for Industry (Draft guidance): Precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from Xenotransplantation product recipients and their intimate contacts (Link: text - PDF)
- Guidance for FDA Reviewers and Sponsors:
Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) (April 2008) (Link: text
)
- Federal register Announcement:
- Criteria that allow federal funding for research using existing embryonic stem cell lines, August, 9, 2001 (Link)
- 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) (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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