Adipose tissue-derived Mesenchymal Stromal Cells: repeated allogenic ASCs IT injections
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of patients experiencing at least one adverse effect — 48 weeks Percentage of patients experiencing at least one adverse effect (AE) due to ASC infusion qualified as CTCAE V5 grade ≥ 3 or qualified as "serious" AE using the MeDRA terminology, and occurring between the first infusion and the end of the follow-up. The severity of the AE and the causality of the ASC infusion will be validated by a DSMB
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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