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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

NCT07735559 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

  • Regenerative Medicine
  • Induced Pluripotent Stem Cells (iPSC) Production

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Christian Jorgensen, MD · University Hospital, Montpellier

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2027-11-30
Completion
2028-02-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735559 on ClinicalTrials.gov