Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592703
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis
Sponsor:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 its 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 ASCs 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 its 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 ASCs infusions
MS patients will be followed for one year after inclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None