drugset / Trial / NCT06360861
Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-07-23
- Primary completion
- 2024-03-04
- Completion
- 2024-03-06
Publications
- Background Shokati A, Naser Moghadasi A, Nikbakht M, Sahraian MA, Mousavi SA, Ai J. A focus on allogeneic mesenchymal stromal cells as a versatile therapeutic tool for treating multiple sclerosis. Stem Cell Res Ther. 2021 Jul 13;12(1):400. doi: 10.1186/s13287-021-02477-5.
- Background Ebrahimi-Barough S, Ai J, Payab M, Alavi-Moghadam S, Shokati A, Aghayan HR, Larijani B, Arjmand B. Standard Operating Procedure for the Good Manufacturing Practice-Compliant Production of Human Endometrial Stem Cells for Multiple Sclerosis. Methods Mol Biol. 2021;2286:199-212. doi: 10.1007/7651_2020_281.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogenic placenta derived mesenchymal stem cells | Cell therapy | 3e+06 cells/kg | Intravenous |