The objective of the study is to establish the first French hospital-based Good Manufacturing Practice (GMP)-compliant platform for the production of clinical-grade induced pluripotent stem cells (iPSCs) for future regenerative medicine applications.
The primary objective is to generate, via the SAFE-iPS platform, 4 clinical-grade iPSC lines derived from peripheral blood samples taken from:
* Two healthy male volunteers * Two healthy female volunteers
These 4 iPSC lines will undergo comprehensive quality assessment including:
* Expression of pluripotency markers * Genomic stability assessment * Absence of residual Sendai viral integration * Technical reproducibility assessment * Manufacturing efficiency assessment * Preliminary medico-economic evaluation This project aims to demonstrate that the SAFE-iPS manufacturing process can be successfully transferred to a hospital Good Manufacturing Practice (GMP) environment and can reproducibly generate clinical-grade iPSC lines meeting international quality standards for future regenerative medicine applications. It also aims to establish the first French public hospital platform dedicated to routine GMP production of clinical-grade iPSCs.
Age ≥ 18 years and ≤ 35 years
No medical contraindication to a 54 mL blood sample collection
Human Immunodeficiency Virus (HIV)
Hepatitis B Virus (HBV)
Any active medical condition
Any ongoingl treatment
Subjects who cannot read and/or write
Inability to ensure participant during the study period