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高雄醫師會誌102期-醫政廣場~林工凱-再生醫療簡介及法制面的建議

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Kalousek
iPS
AI
CAR-T Google Smart
Lens
108
autologous
allogeneic
xenogeneic
Pharmaceuticals
Biologics
Medicaldevices
Celltherapies
Pharmaceuticals
Biologics
Medicaldevices
Celltherapies
Healthcare n...
CD34+ selection hematological malignancies
CIK NK DC DC-CIK
TIL gamma-delta T adoptive
T
hematological malignancies
solid ...
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高雄醫師會誌102期-醫政廣場~林工凱-再生醫療簡介及法制面的建議

  1. 1. Kalousek iPS AI CAR-T Google Smart Lens 108 autologous allogeneic xenogeneic
  2. 2. Pharmaceuticals Biologics Medicaldevices Celltherapies Pharmaceuticals Biologics Medicaldevices Celltherapies Healthcare need Healthcare need Infrastructure Infrastructure 21 (unmet medical need) FDA (Regenerative Medicine Advanced Therapy, RMAT) 2018 3 15 RMAT 8 107 9 6 ( )
  3. 3. CD34+ selection hematological malignancies CIK NK DC DC-CIK TIL gamma-delta T adoptive T hematological malignancies solid tumor bone marrow mesenchymal stem cell
  4. 4. (CPU) (GTP)
  5. 5. IBC IRB NIH FDA CBER IND I~III FDA conditional approval RMAT FDA RMAT (1) (2) (3) (4) (5) FDA 60
  6. 6. 11 27 30% CAR-T Prochymal Cell Communication and Signaling FDA Genetech FDA

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