An Open-label, Non-randomized, Phase I Study of Allogeneic Placenta Derived Mesenchymal Stem Cells in Patients With Secondary-Progressive Multiple Sclerosis (SPMS),

1400-1-233-51589

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.

2019-07-23

2024-03-04

2024-03-06

Completed

Early phase I

5

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label phase 1, single-center, pre-post comparison study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2024-04-11