Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRennes University Hospital

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Adipose tissue-derived Mesenchymal Stromal Cells

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Rennes University Hospital

Lead sponsor

Etablissement Français du Sang

Collaborator