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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
APHP Henri Mondor
RECRUITING
Créteil
CHU Rennes
NOT_YET_RECRUITING
Rennes
Contact Information
Primary
Laure MICHEL, Pr
laure.michel@chu-rennes.fr
0299284321
Backup
Marie-Laure GERVAIS, PhD
marie-laure.gervais@chu-rennes.fr
0299282555
Time Frame
Start Date: 2025-03-06
Estimated Completion Date: 2029-12
Participants
Target number of participants: 10
Treatments
Experimental: Patient
repeated allogenic ASCs IT injections
Related Therapeutic Areas
Sponsors
Leads: Rennes University Hospital
Collaborators: Etablissement Français du Sang

This content was sourced from clinicaltrials.gov