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

Last updated: March 13, 2025
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Memory Loss

Scar Tissue

Multiple Sclerosis

Treatment

Adipose tissue-derived Mesenchymal Stromal Cells

Clinical Study ID

NCT06592703
35RC21_9806_MAESTRO-4MS
  • Ages 18-55
  • All Genders

Study 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 Criteria

Inclusion

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 anypoint 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 CFTGrecommendations (version 1.1)

  • Having signed a free, informed and written consent

  • Affiliated to social security scheme

Exclusion

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: intracranialhypertension, 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, personsunable to express their consent

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Adipose tissue-derived Mesenchymal Stromal Cells
Phase: 1
Study Start date:
March 06, 2025
Estimated Completion Date:
December 31, 2029

Study Description

In this study, the investigators propose, for the first time, to test the safety and the potential efficacy of repeated allogenic Adipose tissue-derived Mesenchymal Stromal Cells (ASCs) IT injections in Primary Progressive Multiple Sclerosis (PPMS) patients. In fact, even if autologous Bone Marrow-Mesenchymal Stromal Cells (BM-MSC) and ASCs have already been infused intrathecally in multiple sclerosis, repeated injections of allogenic ASCs have never been tested in this disease. The use of allogenic cells is driven by recent publications reporting decreased suppressive properties of autologous MSC from MS patients.

The hypothesis is that 3 repeated intrathecal (IT) injections of allogenic ASCs every 3 months will be safe and can lower disease progression in PPMS patients.

Preamble of infusing ASCs in the first patient, it's necessary to constitute and characterize the ASC bank. ASC will be obtained from Allogeneic human mesenchymal stromal cells derived from adipose tissue of a living donor.

Once the bank is available, MS patients will be screened and included in Rennes university hospital to received ASC's infusions.

MS patients will be followed for one year after inclusion

Connect with a study center

  • APHP Henri Mondor

    Créteil,
    France

    Active - Recruiting

  • CHU Rennes

    Rennes,
    France

    Site Not Available

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