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
Single group
Blood Collection for iPSC Generation
Procedure/SurgeryThe study includes telephone and on-site visits at Montpellier University Hospital. Participants will undergo blood collection procedures, including approximately 24 mL for eligibility assessment and approximately 54 mL of heparinized blood for the generation of clinical-grade induced pluripotent stem cell (iPSC) lines on the SAFE-iPS platform.
Successful generation of functional induced pluripotent stem cell (iPSC) lines
The primary outcome of the study is the successful production of four (4) functional human induced pluripotent stem cell (iPSC) lines, comprising two (2) male-derived and two (2) female-derived lines, validated according to international pluripotency standards
Quality of induced pluripotent stem cel (iPSC) lines
Pluripotency marker expression : Percentage of iPSC clones expressing TRA-1-60, SSEA-4, OCT4, and NANOG ≥ 90%
Genomic Safety
100% absence of residual viral integration 100% genomic stability,
Process Reproducibility
Coefficient of variation (CV) \< 20% across key quality parameter
Operational Efficiency
Mean time to complete reprogramming \< 30 days, defined as the time from initial transfection to full pluripotency validation
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