Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
NCT06592703

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

Led by Rennes University Hospital · Updated on 2026-01-05

10

Participants Needed

2

Research Sites

247 weeks

Total Duration

On this page

Sponsors

R

Rennes University Hospital

Lead Sponsor

E

Etablissement Français du Sang

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

APHP Henri Mondor

Créteil, France

Active, Not Recruiting

2

CHU Rennes

Rennes, France

Actively Recruiting

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Research Team

L

Laure MICHEL, Pr

CONTACT

M

Marie-Laure GERVAIS, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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