Spots Global Cancer Trial Database for Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis
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Trial Identification
Brief Title: Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis
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),
Study ID: NCT06360861
Interventions
Study Description
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.
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.
Eligibility
Minimum Age: 17 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tehran University of Medical Sciences,Tehran, Iran, Tehran, , Iran, Islamic Republic of
Contact Details
Name: Abdorreza Naser Moghadasi, MD
Affiliation: Multiple Sclerosis Research Center,Neuroscience Institute,Sina Hospital,Tehran, Iran.
Role: STUDY_DIRECTOR
Name: Mohsen Nikbakht, PhD
Affiliation: Research Institute for Oncology, Hematology& Cell Therapy Facility, Shariati Hospital ,Tehran, Iran.
Role: STUDY_DIRECTOR
Name: Ameneh Shokati, PhD
Affiliation: Applied Cell Sciences,Tehran University of Medical Sciences,Tehran, Iran.
Role: PRINCIPAL_INVESTIGATOR
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