Prof. Lee Ann Laurent-ApplegateDepartment of Musculoskeletal Medicine (DAL)   Reconstructive and Plastic Surgery (CPR)    ...
Summary• Cell Therapies and New Regulations   –   Legal and Regulatory Issues• Selection of Cell Types in Tissue Bioengine...
Transplantation Law: Switzerland1st July, 2007
Regulatory Agencies•   Medications –human•   Medications -veterinary•   Alimentary Complements    and phytotherapy•   Drug...
Regulatory Affairs: Cellular products
Progenitor Cell TransplantationProgram                            Prof. Lee Ann Laurent-Applegate         Prof. Wassim Raf...
New Federally Registered Program:  « Clinical Progenitor Cell Banks »• Began May, 2008• Organ donation: Musculoskeletal Ti...
GMP in regenerative medicine – Buildings and facilities – Organization, personnel, training, evaluation – Equipment, reage...
Primary Tissue/Cell culture                     cGMPTracing of Tissue   Materials & Media                Equipment        ...
CHUV: BH05/516 : Validated Processing  of ”Clinical Progenitor Cell Banks”          Clean Rooms dedicated to Progenitor Ce...
Summary• Cell Therapies and New Regulations   –   Legal and Regulatory Issues• Selection of Cell Types in Tissue Bioengine...
Cells Types for Cell TherapyEmbryonic Stem                   Embryonic Fetal             Fetal                    Adult St...
Progenitor Fetal Cells: Historical Use    Progenitor Cells                                  1930 Polio Vaccine            ...
Cellular Therapy/Tissue Engineering   Cell type              Compatible Matrix           Patient Delivery                 ...
Adult Stem CellsAutologous (Hair Follicle: Epidex®)Treatment of chronic wounds by adult stem cells from hair bulbDelay: 6 ...
Skin Substitutes(Foreskin-Apligraft®)Newborn organ donations (foreskin tissues)              7.5 cm~1,960.- USD for each 7...
Cell Therapy: Why ?                      • Not enough tissue                      • Not rapid enough
Skin Substitutes : Possible for ourburn patients (50%) ?     Apligraf®            Epidex ®     ~1,960.- USD         ~6,280...
Necessity for Skin ReplacementsTransplantation of skin  - Burns: 1,500 hosp./yr Swiss    A real need! CHUV burn center 400...
Summary• Cell Therapies and New Regulations   –   Legal and Regulatory Issues• Selection of Cell Types in Tissue Bioengine...
Primary Tissue/Cell culture
Potential of One Organ    Donation for Burn Treatment     CHUV BH 05  Testing:  Mother Donor: Serology, 1 & 3 months  Feta...
Potential of One Organ    Donation for Burn Treatment     CHUV BH 05                          Bioreliance, Glasgow  Testin...
Potential of One Organ    Donation for Burn Treatment     CHUV BH 05                          Bioreliance, Glasgow  Testin...
Potential of One Organ    Donation for Burn Treatment     CHUV BH 05                          Bioreliance, Glasgow        ...
Capacity of the GMP Cell Bank         Optimiztion of Biobank:         35,000,000,000   (9 x 12 cm)
Lausanne Trial2000-2005• Burns• Acute and Chronic Wounds         Goal:         Reduce surface for autografting
Lausanne Trial10 patients with burns           1        2      3            4                     5After 2weeks  After   1...
Lausanne Trial:              Key elements• Progenitor cells capable of skin regeneration  – Not a «graft »  – Stimulation ...
Lausanne Trialwww.thelancet.com Vol 366 September 3, 2005
Use of MCB and WCB1. cadaver skin replacement              Replace cadaver skin
Skin in a Box:“First Cover”porcine•   Transmission    diseases•   Conservation: fresh,    frozen, glycerol•   Infections  ...
Use of WCB and MCB2. Treatment of Donor Graft Sites
Use of WCB and MCB3. Treatment of Mesh Graft Sites Mesh Grafting •   Increase graft “take” •   Diminish graft dehydration
Innovative Therapies               - Reduction of costs                 - Diminish time hospitalization                 - ...
Medical doctors:Prof. Wassim RaffoulProf. Brigitte Jolles-HaeberliAnthony de Buys Roessingh, MD, PhDSenior Scientists     ...
Thank you Sir Roger & Lady Kristina
Making of…
Making of…
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Skin, Cells, and Skin Grafts Opening Reception - Lee Ann Laurent-Applegate

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Skin, Cells, and Skin Grafts Opening Reception - Lee Ann Laurent-Applegate

  1. 1. Prof. Lee Ann Laurent-ApplegateDepartment of Musculoskeletal Medicine (DAL) Reconstructive and Plastic Surgery (CPR) Unit of Regenerative Therapy (UTR) University Hospital of Lausanne, Switzerland
  2. 2. Summary• Cell Therapies and New Regulations – Legal and Regulatory Issues• Selection of Cell Types in Tissue Bioengineering• Advances and Uses of Progenitor Cells in Burn and Wound Treatments
  3. 3. Transplantation Law: Switzerland1st July, 2007
  4. 4. Regulatory Agencies• Medications –human• Medications -veterinary• Alimentary Complements and phytotherapy• Drugs• Blood and derivatives• Hygenic Articles• Transplants
  5. 5. Regulatory Affairs: Cellular products
  6. 6. Progenitor Cell TransplantationProgram Prof. Lee Ann Laurent-Applegate Prof. Wassim Raffoul Mme Jeanne-Pascale Simon Directrice of Program Co-Directeur of Program Lawyer-CHUV Cellular Therapy Unit, DAL, CHUV 1 single organ donation Master Cell Bank (skin 2 cm2) Frozen –165°CProgram registered with OFSP and Swissmedic since 1993
  7. 7. New Federally Registered Program: « Clinical Progenitor Cell Banks »• Began May, 2008• Organ donation: Musculoskeletal Tissues- Skin - Bone - Cartilage- Disc - Muscle -Tendon08.2007, protocole #62/07:Développement de banques cellulaires fœtales pour ingénierie tissulaire
  8. 8. GMP in regenerative medicine – Buildings and facilities – Organization, personnel, training, evaluation – Equipment, reagents and supplies – Procedures – Production and process controls – Finished product control – Laboratory controls – Records and reports
  9. 9. Primary Tissue/Cell culture cGMPTracing of Tissue Materials & Media Equipment Incubators Liq N2–165°C
  10. 10. CHUV: BH05/516 : Validated Processing of ”Clinical Progenitor Cell Banks” Clean Rooms dedicated to Progenitor Cells: cGMP
  11. 11. Summary• Cell Therapies and New Regulations – Legal and Regulatory Issues• Selection of Cell Types in Tissue Bioengineering• Advances and Uses of Progenitor Cells in Burn and Wound Treatments
  12. 12. Cells Types for Cell TherapyEmbryonic Stem Embryonic Fetal Fetal Adult Stem 0-2 weeks 5-8 weeks 9-14 weeks High manipulation High manipulation  High needs in nutrients  Differentiated cells  Uncertainty for  Problems in uniformity  Easy to handle differenciation  Uncertainty in differenciation  No need of nutrients  High nutritional needs  Tumorigenecity  Problems of uniformity < 100 cells < 100 cells High Number of cells ~1 cell/ 104-5
  13. 13. Progenitor Fetal Cells: Historical Use Progenitor Cells 1930 Polio Vaccine 1954 Nobel Prize of medicine 1964 - 66 • Fetal Cells MRC-5: polio, hepatitis A, chickenNot the same as stem cells pox, measles, rabies• Differentiated Cells• No specific growth factor needs • Fetal Cells WI-38: mumps vaccine (RA 27/3)
  14. 14. Cellular Therapy/Tissue Engineering Cell type Compatible Matrix Patient Delivery + ⁼Patient cellsStem cells CE marked matrix Easy usageProgenitor Fetal Cells for clinical studiesAnimal cells
  15. 15. Adult Stem CellsAutologous (Hair Follicle: Epidex®)Treatment of chronic wounds by adult stem cells from hair bulbDelay: 6 - 8 weeks Modest size 1 cm2 Problems in out-scaling But…Treatment 4 weeks Vac 18 x Epidex 24 x Epidex Cost: 12,095 USD
  16. 16. Skin Substitutes(Foreskin-Apligraft®)Newborn organ donations (foreskin tissues) 7.5 cm~1,960.- USD for each 7.5 cm
  17. 17. Cell Therapy: Why ? • Not enough tissue • Not rapid enough
  18. 18. Skin Substitutes : Possible for ourburn patients (50%) ? Apligraf® Epidex ® ~1,960.- USD ~6,280.- USD for 7.5 cm (x1) for 1.0 cm (18x) ~261,472.- USD ~ 3,529,857.- USD
  19. 19. Necessity for Skin ReplacementsTransplantation of skin - Burns: 1,500 hosp./yr Swiss A real need! CHUV burn center 400,000 cm2/yr - Wounds 1% general population 20% > 80 years 2-4% health costs/1.2-2.4 billion (European wound management, 2010)
  20. 20. Summary• Cell Therapies and New Regulations – Legal and Regulatory Issues• Selection of Cell Types in Tissue Bioengineering• Advances and Uses of Progenitor Cells in Burn and Wound Treatments
  21. 21. Primary Tissue/Cell culture
  22. 22. Potential of One Organ Donation for Burn Treatment CHUV BH 05 Testing: Mother Donor: Serology, 1 & 3 months Fetal Tissue: Pathology, Autopsy & individual tissues, KaroytypeOrgan donation Primary cell culture 1 Parental Cell Bank (PCB) Stored at -165°C
  23. 23. Potential of One Organ Donation for Burn Treatment CHUV BH 05 Bioreliance, Glasgow Testing: Mother Donor: Serology, 1 & 3 months Fetal Tissue: Pathology, Autopsy & individual tissues, KaroytypeOrgan donation Master Cell Bank ~300 vials@ 10 x 106 cells Stored at -165°C Primary cell culture 1 Parental Cell Bank (PCB) Stored at -165°C
  24. 24. Potential of One Organ Donation for Burn Treatment CHUV BH 05 Bioreliance, Glasgow Testing: Mother Donor: Serology, 1 & 3 months Fetal Tissue: Pathology, Autopsy & individual tissues, KaroytypeOrgan donation Master Cell Bank ~300 vials@ 10 x 106 cells Stored at -165°C Primary cell culture 1 Parental Cell Bank (PCB) Stored at -165°C Working Cell Bank ~300 vials@ 10 x 106 cells Stored at -165°C
  25. 25. Potential of One Organ Donation for Burn Treatment CHUV BH 05 Bioreliance, Glasgow CHUV, Clinical Trial Testing: Mother Donor: Serology, 1 & 3 months Fetal Tissue: Pathology, Autopsy & individual tissues, Karoytype cGMP WCB vialOrgan donation Master Cell Bank Direct seeding onto ~300 vials@ 10 x 106 cells collagen matrix Stored at -165°C Primary cell culture 1 Parental ~35 x 109 Treatments Cell Bank (PCB) Stored at -165°C Working Cell Bank ~300 vials@ 10 x 106 cells Global Cost ~ 1-2 million USD Stored at -165°C
  26. 26. Capacity of the GMP Cell Bank Optimiztion of Biobank: 35,000,000,000 (9 x 12 cm)
  27. 27. Lausanne Trial2000-2005• Burns• Acute and Chronic Wounds Goal: Reduce surface for autografting
  28. 28. Lausanne Trial10 patients with burns 1 2 3 4 5After 2weeks After 1.5 mo 18 mo 9 mo 13 mo 18 mo www.thelancet.com Vol 366 September 3, 2005
  29. 29. Lausanne Trial: Key elements• Progenitor cells capable of skin regeneration – Not a «graft » – Stimulation of Patients own cells to regenerate correctly – Hair follicles and sebaceous glands present in regenerated patient skin
  30. 30. Lausanne Trialwww.thelancet.com Vol 366 September 3, 2005
  31. 31. Use of MCB and WCB1. cadaver skin replacement Replace cadaver skin
  32. 32. Skin in a Box:“First Cover”porcine• Transmission diseases• Conservation: fresh, frozen, glycerol• Infections Technique more “clean”
  33. 33. Use of WCB and MCB2. Treatment of Donor Graft Sites
  34. 34. Use of WCB and MCB3. Treatment of Mesh Graft Sites Mesh Grafting • Increase graft “take” • Diminish graft dehydration
  35. 35. Innovative Therapies - Reduction of costs - Diminish time hospitalization - Diminish time care (bandages) - Diminish subsequent surgeries - Simplicity - Universality - Efficacity
  36. 36. Medical doctors:Prof. Wassim RaffoulProf. Brigitte Jolles-HaeberliAnthony de Buys Roessingh, MD, PhDSenior Scientists Prof. Dominique PiolettiNathalie Hirt-Burri, PhDClaude Schweitzer, PhDTechniciansCorinne ScalettaSandra JaccoudMurielle Michetti Prof. Brigitte von RechenbergDoctoral Students:Salim Darwiche, MSEAnthony Grognuz, MSPh Dr Jean-François BauenInterns:Lina DeghayliSara MoufarrijLawyerJeanne-Pascale Simon, JD
  37. 37. Thank you Sir Roger & Lady Kristina
  38. 38. Making of…
  39. 39. Making of…

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