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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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