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Clinical Trial 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.


Clinical Trial 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 McDonald's criteria and Iran's 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 1,3 and 6 months' post treatment. Secondary objective will be efficacy as assessed at baseline, at 1,3 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 Design


Related Conditions & MeSH terms


NCT number NCT06360861
Study type Interventional
Source Tehran University of Medical Sciences
Contact
Status Completed
Phase Phase 1
Start date July 23, 2019
Completion date March 6, 2024

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