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14 rencontres biomédicale LIR Philippe Menasché
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2ND INTERNATIONAL RESEARCH MEETING

2ND INTERNATIONAL RESEARCH MEETING
4 JUNE 2010- HÔTEL DE MARIGNY PARIS

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14 rencontres biomédicale LIR Philippe Menasché Presentation Transcript

  • 1. Stem Cells: Therapeutic Approaches and Pharmaceutical Screening in Cardiovascular Diseases Ph.Menasché Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou & INSERM U633, Paris
  • 2. Stem Cells in France: Research and Therapy
    • Strengths
    • - Long-standing experience in cell therapy
    • - Current efforts to streamline the regulatory process for implementing clinical trials
    • - Tight interactions between basic science laboratories and clinical departments facilitating translational research
  • 3. Embryonic Stem Cells in France
    • The Specific Regulatory Environment of ESC
    • - Permission to work on human ESC under specific approval by a dedicated Agency
    • - To date, 31 approved research teams totalling
    • 39 imported and 24 on-site derived hESC lines
    • - Pending reassessment of the Bioethical Law with low probability of a backward shift
  • 4. Cell Transplantation in Heart Failure: Soon Ready for Prime Time?
    • - Objective : Myocardial regeneration
    • - Preclinical studies of skeletal myoblasts in rodents and sheep (1995-2000)
    Engraftment of myoblasts in an infarcted sheep heart
  • 5. Cell Transplantation in Heart Failure: Soon Ready for Prime Time?
    • - Objective : Myocardial regeneration
    • - Clinical trials (myoblast Tx + CABG) :
    • First in-man Phase I (2000-2001) : 10 patients
    • Phase II (2002-2006) : 97 patients
    MG Biotherapeutics Multicentric Randomized Controlled Dose ranging Double blind Myoblast Autologous Grafting in Ischemic Cardiomyopathy Myoblast injections in infarcted myocardium
  • 6. Cell Transplantation in Heart Failure: Soon Ready for Prime Time?
    • - Objective : Myocardial regeneration
    • - Shift towards human ESC-derived cardiac progenitors (2005- ongoing)
    • Preclinical studies in rodents and nonhuman primates
    • Translational studies in preparation for a pilot phase I trial (scale-up under GMP conditions, extensive safety testing, validation of preclinical runs, development of a cell-seeded biomaterial)
    Blin et al. J Clin Invest 2010; 120:1125-39.
  • 7. Therapeutic Use of Stem Cells
    • Lessons Drawn From the Early Experience
    • - The choice of cells should be tailored to the primary clinical indication
    • - Upgrading cells to a « product » may require allogeneic tissue sources
    • - Cell engraftment (retention + survival) rates must be optimized
  • 8. Therapeutic Use of Stem Cells
    • Lessons Drawn From the Early Experience
    • - The choice of cells should be tailored to the primary clinical indication
    • - Upgrading cells to a « product » may require allogeneic tissue sources
    • - Cell engraftment (retention + survival) rates must be optimized
  • 9. Therapeutic Use of Stem Cells
    • Lessons Drawn From the Early Experience
    • - The choice of cells should be tailored to the primary clinical indication
    • - Upgrading cells to a « product » may require allogeneic tissue sources
    • - Cell engraftment (retention + survival) rates must be optimized
  • 10. Induced Pluripotent Stem Cells Yamanaka S Cell 2009;137:13-17.
  • 11. Induced Pluripotent Stem Cells Cell Stem Cell 2010;6:407-11.
    • Assets of France
    • Development of iPS technology based on
    • previous ESC experience
    • Large patient cohorts
    • Planning to launch government-funded
    • Technology Research Institutes in partnership
    • with private biotech/pharma companies