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

NCT06360861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-04-11

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Allogenic placenta derived mesenchymal stem cells

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

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Abdorreza Naser Moghadasi, MD · Multiple Sclerosis Research Center,Neuroscience Institute,Sina Hospital,Tehran, Iran.

  • Mohsen Nikbakht, PhD · Research Institute for Oncology, Hematology& Cell Therapy Facility, Shariati Hospital ,Tehran, Iran.

  • Ameneh Shokati, PhD · Applied Cell Sciences,Tehran University of Medical Sciences,Tehran, Iran.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2024-03-04
Completion
2024-03-06

Countries

  • Iran

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06360861 on ClinicalTrials.gov