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An Open-label, Non-randomized, Phase I Study of Allogeneic Placenta Derived Mesenchymal Stem Cells in Patients With Secondary-Progressive Multiple Sclerosis (SPMS),
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.
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.
Age
17 - 45 years
Sex
ALL
Healthy Volunteers
No
Tehran University of Medical Sciences,Tehran, Iran
Tehran, Iran
Start Date
July 23, 2019
Primary Completion Date
March 4, 2024
Completion Date
March 6, 2024
Last Updated
April 11, 2024
5
ACTUAL participants
Allogenic placenta derived mesenchymal stem cells
BIOLOGICAL
Lead Sponsor
Tehran University of Medical Sciences
NCT06276634
NCT07225504
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View ClinicalTrials.gov Terms and ConditionsNCT06809192