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

Tehran University of Medical Sciences

Status and phase

Completed

Phase 1

Conditions

Secondary-Progressive Multiple Sclerosis

Multiple Sclerosis

Mesenchymal Stem Cells

Treatments

Biological: Allogenic placenta derived mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT06360861

1400-1-233-51589

IR.TUMS.MEDICINE.REC.1400.197 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

17 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.