NCT06360861

Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 17 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Multiple Sclerosis
• Secondary-Progressive Multiple Sclerosis
• Mesenchymal Stem Cells

Interventions

Type	Name	Description
BIOLOGICAL	Allogenic placenta derived mesenchymal stem cells	Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection.

Timeline

• Start date: 2019-07-23
• Primary completion: 2024-03-04
• Completion: 2024-03-06
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: Iran