NCT06592703

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 multiple-sclerosis

Timeline
44mo left

Started Mar 2025

Longer than P75 for phase_1 multiple-sclerosis

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Mar 2025Dec 2029

First Submitted

Initial submission to the registry

September 6, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

March 6, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

4.7 years

First QC Date

September 6, 2024

Last Update Submit

December 31, 2025

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients experiencing at least one adverse effect

    Percentage of patients experiencing at least one adverse effect (AE) due to ASC infusion qualified as CTCAE V5 grade ≥ 3 or qualified as "serious" AE using the MeDRA terminology, and occurring between the first infusion and the end of the follow-up. The severity of the AE and the causality of the ASC infusion will be validated by a DSMB

    48 weeks

Secondary Outcomes (14)

  • Description of Adverse events related to experimental product

    48 weeks

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

    3 months

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

    48 weeks

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

    48 weeks

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

    48 weeks

  • +9 more secondary outcomes

Study Arms (1)

Patient

EXPERIMENTAL

repeated allogenic ASCs IT injections

Drug: Adipose tissue-derived Mesenchymal Stromal Cells

Interventions

Adipose tissue-derived Mesenchymal Stromal CellsDRUG

repeated allogenic ASCs IT injections

Patient

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Inflammatory activity during the past year (relapses or new T2 MRI lesions)
  • Disease Modifying Drugs during the past year
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

APHP Henri Mondor

Créteil, France

ACTIVE NOT RECRUITING

CHU Rennes

Rennes, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Laure MICHEL, Pr

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure MICHEL, Pr

CONTACT

0299284321laure.michel@chu-rennes.fr

Marie-Laure GERVAIS, PhD

CONTACT

0299282555marie-laure.gervais@chu-rennes.fr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 19, 2024

Study Start

March 6, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

FR(2)