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Professional Guidelines for Stem Cell Translation ISSCR

Professional Guidelines for Stem Cell Translation ISSCR. George Q. Daley Director, Stem Cell Transplantation Center Children’s Hospital/ Harvard Medical School ISSCR President 2007-2008. HSC Transplant activity worldwide 1980-2009. 35,000. 30,000. Autologous. 25,000. 20,000. Transplants.

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Professional Guidelines for Stem Cell Translation ISSCR

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  1. Professional Guidelines for Stem Cell TranslationISSCR

    George Q. Daley Director, Stem Cell Transplantation Center Children’s Hospital/ Harvard Medical School ISSCR President 2007-2008
  2. HSC Transplant activity worldwide 1980-2009 35,000 30,000 Autologous 25,000 20,000 Transplants 15,000 10,000 Allogeneic 5,000 '80 '81 '82 '83 '84 '85 '86 '87 '88 '89 '90 '91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 0 CIBMTR
  3. International Society for Stem Cell Research Promote safe, effective, innovative clinical translation: Educate scientists and medical practitioners world-wide Establish professional standards scientific, medical, ethical Help inform, formulate regulatory pathway Train translational physician scientists Educate patients and their families Spotlight clinics marketing unproven treatments
  4. Stem cell products are entirely novel Stem cells persist in the patient Animal models only partially predictive Why are stem cells different from drugs?
  5. 2008 Deliverable: Patient Handbook Bedrock principles High standards of pre-clinical evidence, peer-reviewed Rigorous quality control around cell manufacture Scrupulous review of clinical protocol by IRB Ensuring informed consent, patient autonomy Rigorous long-term follow-up, reporting of negative results Task force: 30 members, 14 countries Scientists, physicians/surgeons, bioethicists, attorneys Patients/ patient advocates
  6. Few, seriously ill patients Written plan -- Compelling rationale; evidence of efficacy and safety -- Characterization, QC of cells; Description of mode of treatment; -- Rigorous, voluntary informed consent -- Considerations of cost, adverse events, clinical follow-up -- Institutional accountability Review by experts Imminent initiation of a clinical trials process Medical innovation (outside formal clinical trial)
  7. Declaration of Helsinki (10/19/13) http://jama.jamanetwork.com/article.aspx?articleid=1760318&utm_source=silverchair+information+systems&utm_medium=email&utm_campaign=jama%3aonlinefirst10%2f19%2f2013
  8. Promoting ethical, effective care Community and Professional standards Reinforced thru continuing education, practice guidelines, professional societies, peer consultation Professional accreditation/ certifications Practice standards and legal liabilities Tort law and medical malpractice Regulatory oversight Legal, governmental, institutional Market forces Need to address patient, family needs
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