SAFE-iPS - France's First Hospital-based Platform for the Production of Induced Pluripotent Stem Cells for the Regenerative Medicine of the Future
Starting soon · Not applicable
Conditions studied: Regenerative Medicine, Induced Pluripotent Stem Cells (iPSC) Production
In brief
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 facts
- Study ID
- NCT07735559
- Run by
- University Hospital, Montpellier
- People needed
- 6
- Starts
- 2026-11-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age ≥ 18 years and ≤ 35 years
- No medical contraindication to a 54 mL blood sample collection
- Negative viral serology for:
- Human Immunodeficiency Virus (HIV)
- Hepatitis B Virus (HBV)
- Hepatitis C Virus (HCV)
- Human T-lymphotropic Virus type 1 (HTLV-1)
- A participant who agrees to have their anonymized biological samples and cell lines stored in a biological sample collection for other research purposes (including genetic research)
You may not qualify if…
- Any active medical condition
- Any ongoingl treatment
- Subjects who cannot read and/or write
- Inability to ensure participant during the study period
- Participation in another clinical trial or administration of an off-label medication that could interfere with blood test results.
- Participation in another research protocol involving biological sampling that limits the number of mL to be collected.
- Failure to obtain informed consent
- Not enrolled in a social security program,
- Subject participating in another research study with an ongoing exclusion period
- Protected populations under the French Public Health Code (women who are giving birth, breastfeeding, or pregnant; subjects deprived of liberty by judicial or administrative decision; adults under legal protection (under any form of guardianship))
Where it is running
- University Hospital Montpellier — Montpellier, France
Full record on ClinicalTrials.gov
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