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Strong history of stem cell research in Canada

Strong history of stem cell research in Canada. Stem cell concept defined by Leblond (Montreal) and Till and McCulloch (Toronto) in 1960s and 70s Hematopoetic stem cell heritage 11/19 classic stem cell papers(1960-1980) authored by Canadians (Nature Immunol. 2002).

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Strong history of stem cell research in Canada

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  1. Strong history of stem cell research in Canada • Stem cell concept defined by Leblond (Montreal) and Till and McCulloch (Toronto) in 1960s and 70s • Hematopoetic stem cell heritage • 11/19 classic stem cell papers(1960-1980) authored by Canadians (Nature Immunol. 2002)

  2. Recent Canadian discoveries in stem cell science • Neural stem cells from adult brain (Weiss, Calgary) • Retinal stem cells (van der Kooy, McInnes, Toronto) • Skin-derived stem cells (Miller, Montreal/Toronto) • Muscle stem cells redefined (Rudnicki, Ottawa) • ES cell potential to make mice (Nagy/Rossant, Toronto) • Expansion of hematopoetic stem cells (Sauvageau, Montreal; Humphries, Vancouver; Bhatia, London)

  3. Translation to therapy • Strong research environment in ethical, legal and social issues regarding stem cells • Leaders in stem cell and tissue bioengineering • Excellence in clinical transplant protocols • Fetal tissue transplants for Parkinson’s (Mendez, Halifax) • Islet transplantation for diabetes (Shapiro, Edmonton protocol)

  4. Regulation of stem cell research in Canada • Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans includes general guidelines for research on human embryos and fetal material (1998) • CIHR guidelines (March 2002) • Bill C-56 (May 2002), re-named C-13 in October 2002

  5. CIHR research guidelines:guiding principles • Free and informed consent with full disclosure • Respect for privacy and confidentiality • No direct or indirect payment or financial incentives

  6. Fundable research: derivation of stem cells • ES cells from “spare” IVF embryos • Embryonic germ cells from fetal tissue • Stem cells from amniotic fluid • Umbilical cord and placenta • Somatic tissues

  7. Other fundable research • Research on existing human pluripotent stem cell lines • Provided they are created according to CIHR guidelines • Chimera research • Grafting of human stem cells into non-human animals from birth to adult, under certain conditions • Grafting of human stem cell lines into legally competent humans, under certain conditions

  8. Not eligible for funding • Creation of embryos for research purposes • Nuclear transfer (cloning) to create embryos for stem cell derivation • Directed donation of stem cell lines unless for autologous donation • Chimeras: experiments involving human embryos and fetuses, or animal embryos and fetuses with human stem cells

  9. Consent process • Options for excess embryos must be discussed with gamete providers and embryo providers (if these are different), and a decision made, prior to gamete collection. • Consent must be confirmed when research begins. If gamete providers are not the same as embryo providers, and unrestricted consent was given at the time of donation, renewal is not required. • Fetal tissue: research option discussed only after free and informed choice to have an abortion.

  10. Voluntariness • The physician responsible for fertility treatment, and the person seeking consent to use embryos, may not be part of the stem cell research team. • Re-confirmation of consent at time of research use (except gamete providers when not the same as embryo providers). • Consent revocable (except gamete providers when not the same as embryo providers) until anonymized cell line created. • No pressure from researchers to produce excess embryos. • Consent to research never a condition of access to treatment.

  11. Ethics review: Stem Cell Oversight Committee • National oversight body: rationale • Accountability, public confidence • Expertise to review specialized research • Minimize potential for conflict of interest • Review process • CIHR peer review  National oversight  REB • National oversight body and REB must both approve • Oversight body accountable to the Governing Council of CIHR

  12. Bill C-13: An Act respectingassisted human reproduction • Regulates IVF procedures and all other embryo manipulation and research • Principles: • Protection and promotion of human health, safety, dignity and rights in the use of reproductive technologies and in related research • Human individuality and diversity and integrity of the human genome • C-13 applies to all research in Canada and takes precedence where CIHR guidelines and the legislation conflict. CIHR guidelines apply only to CIHR-funded research.

  13. Bill C-13: Prohibitions relating to research • Creating an embryo for research • Therapeutic cloning • Germline alteration of embryos • Creation of chimeras (animal to human) • Purchase of in vitro embryos

  14. Bill C-13: Controlled Activities Relating to Stem Cell Research • Manipulation of embryos (i.e. creation of stem cell lines) • Importing and exporting embryos

  15. Other Aspects of Bill C-13 • Privacy, health reporting information, and access to information • Details on how the Agency will operate • 3 year Parliamentary review • “Grandfather” clause provision

  16. CIHR C-13 Creating research embryos No No Cloning (nuclear transfer) No No Cloning (reproductive) No No Germline genetic alteration No Chimera (aSC or hSC + hum. emb.) No No Chimera (aSC or hSC + hum. fetus) No Chimera (hSC + an. embryo No Chimera (hSC + an. fetus) No Hybrids No Existing hum. ES cell lines Yes* Deriv. of SC from spare IVF emb. Yes* Yes* Deriv. of SC from fetal material Yes* Note: * = with conditions Comparison of Canadian Regulatory Frameworks

  17. Stem Cell Network • An independent, not-for-profit corporation • Funded for $21 million over four years • Part of federal government’s Networks of Centres of Excellence Program

  18. Network research program • Stem cell characterization • Cell biology, plasticity, genomics, proteomics • Ethical, legal, and social framework development • Interdisciplinary team approaches to new therapies • Diabetes • Neurodegeneration • Stroke • Cardiac disease • Muscular dystrophies

  19. Network activities • Fund large collaborative, multi-disciplinary, multi-institutional research projects • Provide advice and support to universities on commercializing stem cell research • Run a national stem cell training initiative • Act as the voice of science in the legislative process • Develop industrial, NGO, and government partnerships for academic stem cell research

  20. Stem cell funding in Canada • Multiple sources: • CIHR • Stem Cell Network • Genome Canada • NIH • Health Charities • ~$20 million in 2001/02 to Network labs • ~$50 million already committed through 2004/2005 • Start-up and established companies with stem cell focus

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