SAFE-iPS - France's First Hospital-based Platform for the Production of Induced Pluripotent Stem Cells for the Regenerative Medicine of the Future

NCT07735559 | Not Yet Recruiting

• 2 other identifiers: RECHMPL25_04952025-A02938-41
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Regenerative Medicine; Induced Pluripotent Stem Cells (iPSC) Production

Keywords

Induced pluripotent stem cells (iPSCs),; regenerative medicine,; cell therapy; directed differentiation; clinical-grade production (or GMP manufacturing)

Outcome Measures

Primary Outcomes (1)

• Successful generation of functional induced pluripotent stem cell (iPSC) lines

  The primary outcome of the study is the successful production of four (4) functional human induced pluripotent stem cell (iPSC) lines, comprising two (2) male-derived and two (2) female-derived lines, validated according to international pluripotency standards

  upon completion of reprogramming and full validation, within ≤ 60 days post-transfection

Secondary Outcomes (5)

• Quality of induced pluripotent stem cel (iPSC) lines

  Day 21 to Day 30 post-reprogramming

• Genomic Safety

  Day 45 to Day 60 post-reprogramming

• Process Reproducibility

  Month 3

• Operational Efficiency

  Through production phase, less than 30 days

• Economic Evaluation

  Month 3

Study Arms (1)

Healthy Volunteers Undergoing Blood Collection for iPSC Generation

EXPERIMENTAL

Healthy volunteers undergoing study procedures including blood collection for the generation and characterization of clinical-grade induced pluripotent stem cell (iPSC) lines on the SAFE-iPS platform

Procedure: Blood Collection for iPSC Generation

Interventions

Blood Collection for iPSC Generation PROCEDURE

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.

Healthy Volunteers Undergoing Blood Collection for iPSC Generation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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,
• 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))

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital Montpellier

Montpellier, France

Location

Study Officials

• Christian Jorgensen, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Christian Jorgensen, MD

CONTACT

04 67 33 77 98; c-jorgensen@chu-montpellier.fr

Romain Desprat

CONTACT

04 67 33 26 41; r-desprat@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, monocentric, open-label, single-group feasibility study conducted in healthy volunteers. All participants will undergo the same procedures, including blood collection for the production and characterization of clinical-grade iPSC lines on the SAFE-iPS platform.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

FR (1)