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RECRUITINGPhase 1INTERVENTIONAL

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Adipose tissue-derived Mesenchymal Stromal Cells

repeated allogenic ASCs IT injections

Locations (2)

APHP Henri Mondor
Créteil, France
CHU Rennes
Rennes, France