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Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis: an Open-label Phase I Clinical Trial.
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.
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
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
APHP Henri Mondor
Créteil, France
CHU Rennes
Rennes, France
Start Date
March 6, 2025
Primary Completion Date
December 1, 2029
Completion Date
December 1, 2029
Last Updated
January 5, 2026
10
ESTIMATED participants
Adipose tissue-derived Mesenchymal Stromal Cells
DRUG
Lead Sponsor
Rennes University Hospital
Collaborators
NCT07225504
NCT06276634
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06809192