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NCT07735559
SAFE-iPS - France's First Hospital-based Platform for the Production of Induced Pluripotent Stem Cells for the Regenerative Medicine of the Future
Conditions: Regenerative Medicine, Induced Pluripotent Stem Cells (iPSC) Production
Sex: All
Ages: 18 Years – 35 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 6
Sponsor: University Hospital, Montpellier
Location: University Hospital Montpellier 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.
Eligibility Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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))
Source: ClinicalTrials.gov (NCT07735559). StuddyBuddy aggregates publicly available trial information.