Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adipose tissue-derived Mesenchymal Stromal Cells.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis: an Open-label Phase I Clinical Trial.
Overview
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.
Detailed 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
Interventions
- Drug Adipose tissue-derived Mesenchymal Stromal Cells
repeated allogenic ASCs IT injections
Primary outcome measures
- Percentage of patients experiencing at least one adverse effect [Time frame: 48 weeks]
Secondary outcome measures (12)
- Description of Adverse events related to experimental product [Time frame: 48 weeks]
- Clinical disease evolution at Week24 and Week48 after treatment : Confirmed Disability Progression using Expanded Disability Status Scale score [Time frame: 3 months]
- Clinical disease evolution at Week24 and Week48 after treatment : Expanded Disability Status Scale score [Time frame: 48 weeks]
- Clinical disease evolution at Week24 and Week48 after treatment : Expanded Disability Status Scale score [Time frame: 48 weeks]
- Clinical disease evolution at Week24 and Week48 after treatment : no evidence progression using 9HPT test [Time frame: 48 weeks]
- Clinical disease evolution at Week24 and Week48 after treatment : no evidence progression using T25-FW [Time frame: 48 weeks]
- Clinical disease evolution at Week24 and Week48 after treatment : MSFC mean changes [Time frame: 48 weeks]
- Quality of life disease evolution at Week24 and Week48 after treatment : Multiple Sclerosis International Quality Of Life (MusiQoL) questionnaire [Time frame: 48 weeks]
- Immunophenotyping [Time frame: 48 weeks]
- Detection of donor specific anti-HLA antibodies in the blood [Time frame: 28 weeks]
- MRI parameters : gadolinium (Gd) enhancing lesions [Time frame: 48 weeks]
- MRI parameters : new T2 lesions [Time frame: 48 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- APHP Henri Mondor — Créteil
- CHU Rennes — Rennes
Identifiers
NCT: NCT06592703 · 35RC21_9806_MAESTRO-4MS