Using fat-derived stem cells to treat 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.

This study is testing if injections of fat-derived stem cells can help people with primary progressive multiple sclerosis feel better and slow down their disease.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Rennes University Hospital (other)
• Locations: 2 sites (Créteil and 1 other locations)
• Trial ID: NCT06592703 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and potential effectiveness of repeated injections of allogenic adipose tissue-derived mesenchymal stromal cells (ASCs) in patients with primary progressive multiple sclerosis (PPMS). The approach involves administering three intrathecal injections of ASCs every three months, with the hypothesis that this treatment can slow disease progression. The study will begin by establishing a bank of ASCs from healthy donors, followed by screening and enrolling eligible PPMS patients at Rennes University Hospital. Participants will be monitored for one year after receiving the injections.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 55 with a confirmed diagnosis of primary progressive multiple sclerosis and specific disability criteria.

Not a fit: Patients with recent inflammatory activity or those currently on disease-modifying drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option to slow the progression of primary progressive multiple sclerosis.

How similar studies have performed: While autologous stem cell therapies have been explored in multiple sclerosis, the use of allogenic adipose-derived stem cells in this context is novel and has not been previously tested.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Créteil and 1 other locations

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

Study contacts

• Principal investigator: Laure MICHEL, Pr — Rennes University Hospital
• Study coordinator: Laure MICHEL, Pr

Conditions: Multiple Sclerosis