MSFrontier

MAESTRO-4MS

Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis: an Open-label Phase I Clinical Trial.
RecruitingPhase 1Progressive MSNCT06592703

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Adipose tissue-derived Mesenchymal Stromal Cells

What it measured

Main measures

  • Percentage of patients experiencing at least one adverse effect

    48 weeks

    Safety

Other measures (13)

  • Description of Adverse events related to experimental product

    48 weeks

    Safety

  • Clinical disease evolution at Week24 and Week48 after treatment : Confirmed Disability Progression using Expanded Disability Status Scale score

    3 months

    Disability progression

  • Clinical disease evolution at Week24 and Week48 after treatment : Expanded Disability Status Scale score

    48 weeks

    Disability progression

  • Clinical disease evolution at Week24 and Week48 after treatment : no evidence progression using 9HPT test

    48 weeks

    Disability progressionArm and hand function

  • Clinical disease evolution at Week24 and Week48 after treatment : no evidence progression using T25-FW

    48 weeks

    Disability progressionWalking and mobility

  • Clinical disease evolution at Week24 and Week48 after treatment : MSFC mean changes

    48 weeks

    Disability progressionThinking and memory

  • Quality of life disease evolution at Week24 and Week48 after treatment : Multiple Sclerosis International Quality Of Life (MusiQoL) questionnaire

    48 weeks

    Bladder, bowel and sexual functionQuality of life (reported by participants)

  • Immunophenotyping

    48 weeks

    Blood or spinal fluid markersImmune response

  • Detection of donor specific anti-HLA antibodies in the blood

    28 weeks

  • MRI parameters : gadolinium (Gd) enhancing lesions

    48 weeks

    MRI lesions

Who could take part

Progressive MS · 18 to 55

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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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    Related trials

    History

      1. Started

        Mar 2025

      2. Main results due

        Dec 2029

      3. Finished

        Dec 2029

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