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SAFE-iPS - France's First Hospital-based Platform for the Production of Induced Pluripotent Stem Cells for the Regenerative Medicine of the Future
Sponsor: University Hospital, Montpellier
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2026-11
Completion Date
2028-02
Last Updated
2026-07-30
Healthy Volunteers
Yes
Interventions
Blood Collection for iPSC Generation
The 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.
Locations (1)
University Hospital Montpellier
Montpellier, France