Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-19 @ 7:27 AM
Study NCT ID:
NCT06592703
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2024-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis
Sponsor:
Rennes University Hospital
Organization:
Study Overview
Official Title:
Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis: an Open-label Phase I Clinical Trial.
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAESTRO-4MS
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: