RecruitingPhase 1NCT06592703

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.

Sponsor

Rennes University Hospital

Enrollment

10 participants

Start Date

Mar 6, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria8

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 Criteria6

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