Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis
Recruiting · NCT06592703 · Interventional (participants receive a specific treatment) · Lead sponsor: Rennes University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Adipose tissue-derived Mesenchymal Stromal Cells
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed.
- APHP Henri Mondor - Créteil, France
- CHU Rennes - Rennes, France