Using fat-derived stem cells to treat primary progressive multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Rennes
  Rennes, France Recruiting
• APHP Henri Mondor
  Créteil, France Active not recruiting

Study contacts

• Principal investigator: Laure MICHEL, Pr — Rennes University Hospital
• Study coordinator: Laure MICHEL, Pr
• Email: laure.michel@chu-rennes.fr
• Phone: 0299284321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.