NCT06592703RecruitingPhase 1
Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis
Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis: an Open-label Phase I Clinical Trial.
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
In this study, we propose, for the first time, to test the safety and the potential efficacy of repeated allogenic Adipose tissue-derived Mesenchymal Stromal Cells IT injections in Primary Progressive Multiple Sclerosis patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 6 Sept 2024
- Start date
- 6 Mar 2025
- Primary completion date
- Dec 2029
- Lead sponsor
- Rennes University Hospital
- Diseases
- Multiple sclerosis
- NCT number
- NCT06592703
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 6 Mar 2025 to the primary completion date, Dec 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with high dose corticosteroids during the 30 days preceding the inclusion
Other illness
- Disease Modifying Drugs during the past year
Lab values
- Contra indication to lumbar puncture/intrathecal infusion: intracranial hypertension, puncture site infections, severe thrombocytopenia (\<50 G/L), anticoagulant or fibrinolytic treatment
Other
- Inflammatory activity during the past year (relapses or new T2 MRI lesions)
- Participation in another therapeutic trial in the last 6 months
- Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty, pregnant or breastfeeding women, minors, persons unable to express their consent
Who the study is looking for
- Patient with Primary Progressive MS according to the criteria of Mc Donald 2017 (Thompson et al Lancet neurol, 2017)
- Age between 18 and 55 years
- EDSS score: 3 to 6 at inclusion
- Documented evidence of disability progression independent of relapse activity at any point in time over the 2 years prior to the screening visit
- Positive CSF with oligoclonal bands
- For women of childbearing potential (WOCBP), effective contraception as per the CFTG recommendations (version 1.1)
- Having signed a free, informed and written consent
- Affiliated to social security scheme
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| APHP Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Active, not recruiting |
| CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.