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

NCT ID: NCT06592703

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-06
• Study Completion Date: 2029-12-31

Brief 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.

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

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient

repeated allogenic ASCs IT injections

Group Type: EXPERIMENTAL

Adipose tissue-derived Mesenchymal Stromal Cells

Intervention Type: DRUG

repeated allogenic ASCs IT injections

Interventions

Adipose tissue-derived Mesenchymal Stromal Cells

repeated allogenic ASCs IT injections

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Etablissement Français du Sang

OTHER

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laure MICHEL, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

APHP Henri Mondor

Créteil, , France

Site Status: ACTIVE_NOT_RECRUITING

CHU Rennes

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Laure MICHEL, Pr

Role: CONTACT

laure.michel@chu-rennes.fr

0299284321 ext. +33

Marie-Laure GERVAIS, PhD

Role: CONTACT

marie-laure.gervais@chu-rennes.fr

0299282555 ext. +33

Facility Contacts

Laure MICHEL, Pr

Role: primary

Other Identifiers

35RC21_9806_MAESTRO-4MS

Identifier Type: -

Identifier Source: org_study_id