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Not Yet Recruiting 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))

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07735559). StuddyBuddy aggregates publicly available trial information.