Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis (MAESTRO-4MS)

Rennes University Hospital

Status and phase

Enrolling

Phase 1

Conditions

Multiple Sclerosis

Treatments

Drug: Adipose tissue-derived Mesenchymal Stromal Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT06592703

35RC21_9806_MAESTRO-4MS

Details and patient eligibility

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.

Full 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

Enrollment

10 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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