CompletedPhase 1

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

Iran5 participantsStarted 2019-07-23

Plain-language 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.

Who can participate

Age range17 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Criteria: Inclusion Criteria: * Age between 17-45 years Patients with SPMS . * Must be able to Sign informed consent . * Currently taking Rituximab. * Disease duration of more than 2 and less than 16 years. Exclusion Criteria: * Pregnancy or breastfeeding. * hepatitis B and C, human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) disease. * Using cytotoxic agents within 3 months prior to the study. * Severe anemia (hemoglobin\< 8 mg/dl), coagulation disorders. * history of malignancy . * liver disorders . * significant cardiac, renal or hepatic failure . * Active or chronic infection. * Life-threatening organ dysfunction. * Unable to give written informed consent . * Current treatment with an investigational therapy.

What they're measuring

Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability].

Timeframe: Up to 6 months

Trial details

NCT IDNCT06360861

SponsorTehran University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-04

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