Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis

Recruiting now · Phase 1

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT06592703

Run by

Rennes University Hospital

People needed

10

Starts

2025-03-06

Expected to finish

2029-12-01

Last updated by the study team

2026-01-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Inflammatory activity during the past year (relapses or new T2 MRI lesions)
• Disease Modifying Drugs during the past year
• Treatment with high dose corticosteroids during the 30 days preceding the inclusion
• Contra indication to lumbar puncture/intrathecal infusion: intracranial hypertension, puncture site infections, severe thrombocytopenia (<50 G/L), anticoagulant or fibrinolytic treatment
• 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

Where it is running

• CHU Rennes — Rennes, France (enrolling)
• APHP Henri Mondor — Créteil, France

Full record on ClinicalTrials.gov

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