Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360861
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2024-03-17
Brief Title:
Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
An Open-label Non-randomized Phase I Study of Allogeneic Placenta Derived Mesenchymal Stem Cells in Patients With Secondary-Progressive Multiple Sclerosis SPMS
Status:
COMPLETED
Status Verified Date:
2024-03
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:
MS
Brief Summary:
To assess the safety and of a single dose of IV infusion of placenta derived Mesenchymal Stem Cells PLMSCs in patients with secondary progressive Multiple Sclerosis SPMS disease
Monitoring will be encompassed baseline assessments and follow-ups over subsequent months evaluating clinical signs Expanded Disability Status Scale EDSS cytokines diffusion tensor imaging DTI functional MRI fMRI cognitive psychological evaluations and flow cytometry for B cell markers
Monitoring will be encompassed baseline assessments and follow-ups over subsequent months evaluating clinical signs Expanded Disability Status Scale EDSS cytokines diffusion tensor imaging DTI functional MRI fMRI cognitive psychological evaluations and flow cytometry for B cell markers
Detailed Description:
This open-label phase I study will be conducted in MS Clinic of Sina and Shariati Hospital of Tehran province
In this study diagnosis and management of MS patients will be performed based on McDonalds criteria and Irans diagnostic and treatment protocols
The patients will be received a single injection of PLMSCs through the intravenous cannula
The proposed study will assess safety and short efficacy endpoints of PLMSCs administered to 5 patients with SPMS
The primary objective of the trial is freedom from treatment associated adverse events at 13 and 6 months post treatment Secondary objective will be efficacy as assessed at baseline at 13 and 6 months and will be based on the following EDSS cytokines DTI fMRI cognitive psychological evaluations and flow cytometry for B cell markers
In this study diagnosis and management of MS patients will be performed based on McDonalds criteria and Irans diagnostic and treatment protocols
The patients will be received a single injection of PLMSCs through the intravenous cannula
The proposed study will assess safety and short efficacy endpoints of PLMSCs administered to 5 patients with SPMS
The primary objective of the trial is freedom from treatment associated adverse events at 13 and 6 months post treatment Secondary objective will be efficacy as assessed at baseline at 13 and 6 months and will be based on the following EDSS cytokines DTI fMRI cognitive psychological evaluations and flow cytometry for B cell markers
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRTUMSMEDICINEREC1400197 | OTHER_GRANT | Tehran University of Medical Sciences | None |