Regenerative MedicineSAFE-iPSNCT07735559
SAFE-iPS - France's First Hospital-based Platform for the Production of Induced Pluripotent Stem Cells for the Regenerative Medicine of the Future
A study testing Blood Collection for iPSC Generation in people with Regenerative Medicine and Induced Pluripotent Stem Cells (iPSC) Production, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Regenerative Medicine, Induced Pluripotent Stem Cells (iPSC) Production
- What is being tested?
- Blood Collection for iPSC Generation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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))
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital Montpellier
Montpellier
Christian Jorgensen, MD, 04 67 33 77 98, c-jorgensen@chu-montpellier.fr
Romain DESPRAT, 04 67 33 26 41, r-desprat@chu-montpellier.fr
About this study
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:
Read more
- 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.
Read the detailed description
Background :
Induced pluripotent stem cells (iPSCs) represent a major advance in regenerative medicine because they can be generated from easily accessible autologous somatic cells and differentiated into virtually any cell type. Their potential clinical applications include hematology, neurology, rare diseases, oncology, and regenerative medicine. However, translation of this technology into clinical practice requires Good Manufacturing Practice (GMP)-compliant production processes and stringent quality standards for Advanced Therapy Medicinal Products (ATMPs).
Currently, no French public hospital has a validated and routinely operational GMP platform dedicated to the production of clinical-grade iPSC lines. The SAFE-iPS platform at Montpellier University Hospital combines dedicated clean-room facilities, an ISO 13485-certified quality management system, and more than ten years of expertise in iPSC production and characterization, providing the necessary infrastructure to establish such a platform.
The central hypothesis of the study is that peripheral blood mononuclear cell (PBMC) reprogramming using a non-integrating Sendai viral vector expressing OCT4, KLF4, SOX2 and c-MYC (OKSM) can be successfully implemented in a hospital GMP environment and reproducibly generate clinical-grade iPSC lines fulfilling international quality requirements for future clinical applications.
Objectives :
Primary objective :
The primary objective is to generate, via the SAFE-iPS platform, four clinical-grade iPSC lines derived from peripheral blood samples collected from healthy volunteers:
- Two healthy male volunteers
- Two healthy female volunteers These iPSC lines will be validated according to international pluripotency criteria for future regenerative medicine applications.
Secondary objectives :
Secondary objectives are to:
- Validate genomic safety.
- Evaluate technical reproducibility.
- Evaluate manufacturing efficiency.
- Evaluate the preliminary medico-economic feasibility of the production process.
Study Procedures :
Healthy volunteers will undergo screening, eligibility assessment and peripheral blood collection. Peripheral blood mononuclear cells (PBMCs) will be isolated and reprogrammed using a non-integrating Sendai viral vector under GMP conditions to generate clinical-grade iPSC lines.
The generated cell lines will undergo quality control assessments including evaluation of pluripotency marker expression, genomic stability, absence of residual viral integration, technical reproducibility, manufacturing time and production costs. The study is designed as a prospective, monocentric, open-label, non-comparative pilot feasibility study evaluating the implementation of a hospital-based GMP manufacturing process.
Study Population :
A maximum of six healthy adult volunteers will be enrolled to obtain two validated clinical-grade iPSC lines from male donors and two from female donors. Enrollment will stop once the four clinical-grade iPSC lines meeting international pluripotency criteria have been successfully generated.
Expected Impact :
The SAFE-iPS study is expected to validate the first French public hospital GMP production process dedicated to clinical-grade iPSC manufacturing. The generated data will support future applications for Advanced Therapy Medicinal Products (ATMPs), establish a pilot biobank of clinical-grade iPSC lines, and provide a reproducible organizational and technical model that may subsequently be implemented in other French university hospitals to facilitate the development of regenerative medicine and cell therapy.
- Being tested
- Blood Collection for iPSC Generation
- Keywords
- Induced pluripotent stem cells (iPSCs),, regenerative medicine,, cell therapy, directed differentiation, clinical-grade production (or GMP manufacturing)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Collection for iPSC GenerationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Blood Collection for iPSC Generation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: upon completion of reprogramming and full validation, within ≤ 60 days post-transfection
Secondary outcomes (5)
Quality of induced pluripotent stem cel (iPSC) lines
Pluripotency marker expression : Percentage of iPSC clones expressing TRA-1-60, SSEA-4, OCT4, and NANOG ≥ 90%
Measured: Day 21 to Day 30 post-reprogramming
Genomic Safety
100% absence of residual viral integration 100% genomic stability,
Measured: Day 45 to Day 60 post-reprogramming
Process Reproducibility
Coefficient of variation (CV) < 20% across key quality parameter
Measured: Month 3
Operational Efficiency
Mean time to complete reprogramming < 30 days, defined as the time from initial transfection to full pluripotency validation
Measured: Through production phase, less than 30 days
Economic Evaluation
Total production cost per iPSC line ≤ €25,000, including personnel, consumables, and quality control
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative MedicineStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Jorgensen, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735559
- Sponsor's protocol ID
- RECHMPL25_0495
- Other IDs
- 2025-A02938-41
- Acronym
- SAFE-iPS
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07735559
- Acronym / sponsor ID
- SAFE-iPS / RECHMPL25_0495
- Keywords
- Induced pluripotent stem cells (iPSCs),, regenerative medicine,, cell therapy, directed differentiation, clinical-grade production (or GMP manufacturing)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background :
Induced pluripotent stem cells (iPSCs) represent a major advance in regenerative medicine because they can be generated from easily accessible autologous somatic cells and differentiated into virtually any cell type. Their potential clinical applications include hematology, neurology, rare diseases, oncology, and regenerative medicine. However, translation of this technology into clinical practice requires Good Manufacturing Practice (GMP)-compliant production processes and stringent quality standards for Advanced Therapy Medicinal Products (ATMPs).
Currently, no French public hospital has a validated and routinely operational GMP platform dedicated to the production of clinical-grade iPSC lines. The SAFE-iPS platform at Montpellier University Hospital combines dedicated clean-room facilities, an ISO 13485-certified quality management system, and more than ten years of expertise in iPSC production and characterization, providing the necessary infrastructure to establish such a platform.
The central hypothesis of the study is that peripheral blood mononuclear cell (PBMC) reprogramming using a non-integrating Sendai viral vector expressing OCT4, KLF4, SOX2 and c-MYC (OKSM) can be successfully implemented in a hospital GMP environment and reproducibly generate clinical-grade iPSC lines fulfilling international quality requirements for future clinical applications.
Objectives :
Primary objective :
The primary objective is to generate, via the SAFE-iPS platform, four clinical-grade iPSC lines derived from peripheral blood samples collected from healthy volunteers:
- Two healthy male volunteers
- Two healthy female volunteers These iPSC lines will be validated according to international pluripotency criteria for future regenerative medicine applications.
Secondary objectives :
Secondary objectives are to:
- Validate genomic safety.
- Evaluate technical reproducibility.
- Evaluate manufacturing efficiency.
- Evaluate the preliminary medico-economic feasibility of the production process.
Study Procedures :
Healthy volunteers will undergo screening, eligibility assessment and peripheral blood collection. Peripheral blood mononuclear cells (PBMCs) will be isolated and reprogrammed using a non-integrating Sendai viral vector under GMP conditions to generate clinical-grade iPSC lines.
The generated cell lines will undergo quality control assessments including evaluation of pluripotency marker expression, genomic stability, absence of residual viral integration, technical reproducibility, manufacturing time and production costs. The study is designed as a prospective, monocentric, open-label, non-comparative pilot feasibility study evaluating the implementation of a hospital-based GMP manufacturing process.
Study Population :
A maximum of six healthy adult volunteers will be enrolled to obtain two validated clinical-grade iPSC lines from male donors and two from female donors. Enrollment will stop once the four clinical-grade iPSC lines meeting international pluripotency criteria have been successfully generated.
Expected Impact :
The SAFE-iPS study is expected to validate the first French public hospital GMP production process dedicated to clinical-grade iPSC manufacturing. The generated data will support future applications for Advanced Therapy Medicinal Products (ATMPs), establish a pilot biobank of clinical-grade iPSC lines, and provide a reproducible organizational and technical model that may subsequently be implemented in other French university hospitals to facilitate the development of regenerative medicine and cell therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers Undergoing Blood Collection for iPSC Generation | Experimental | Procedure: Blood Collection for iPSC GenerationHealthy 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years and ≤ 35 years
- No medical contraindication to a 54 mL blood sample collection
- Negative viral serology for:
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Collection for iPSC GenerationThe 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. | Procedure or surgery | Healthy Volunteers Undergoing Blood Collection for iPSC Generation |
Primary outcome
Successful generation of functional induced pluripotent stem cell (iPSC) lines
Time frame: upon completion of reprogramming and full validation, within ≤ 60 days post-transfection
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
5 secondary outcomes
Quality of induced pluripotent stem cel (iPSC) lines
Time frame: Day 21 to Day 30 post-reprogramming
Genomic Safety
Time frame: Day 45 to Day 60 post-reprogramming
Process Reproducibility
Time frame: Month 3
Operational Efficiency
Time frame: Through production phase, less than 30 days
Economic Evaluation
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Jorgensen, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Collection for iPSC Generation in people with Regenerative Medicine and Induced Pluripotent Stem Cells (iPSC) Production, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Jorgensen, MD (04 67 33 77 98, c-jorgensen@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful generation of functional induced pluripotent stem cell (iPSC) lines (time frame: upon completion of reprogramming and full validation, within ≤ 60 days post-transfection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.