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NCT07735559

Overview

NCT ID: NCT07735559
Lead Sponsor: University Hospital, MontpellierOTHER
Official Title: SAFE-iPS - France's First Hospital-based Platform for the Production of Induced Pluripotent Stem Cells for the Regenerative Medicine of the Future
Brief 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.

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
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))

Central Contacts: Christian Jorgensen, MDContact
c-jorgensen@chu-montpellier.fr04 67 33 77 98