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

NCT06360861 | Completed Phase 1 DMC

• 2 other identifiers: 1400-1-233-51589IR.TUMS.MEDICINE.REC.1400.197
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Secondary-Progressive Multiple Sclerosis; Mesenchymal Stem Cells

Keywords

Mesenchymal Stem cells; Multiple Sclerosis; Placenta derived Mesenchymal Stem Cells; Stem Cell therapy; Neuroimmunology; Autoimmune Disease

Outcome Measures

Primary Outcomes (1)

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

  adverse events

  Up to 6 months

Secondary Outcomes (19)

• Number of participants with a change in disability as measured by Expanded Disability Status Scale .

  Up to 6 months

• Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test .

  Up to 6 months

• Number of participants with a change in cognitive performance as measured by Persian version of minimal assessment of cognitive function in MS battery.

  Up to 6 months

• Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging .

  Up to 6 months

• Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging .

  Up to 6 months

Study Arms (1)

Placenta derived mesenchymal cells

EXPERIMENTAL

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

Biological: Allogenic placenta derived mesenchymal stem cells

Interventions

Allogenic placenta derived mesenchymal stem cells BIOLOGICAL

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

Placenta derived mesenchymal cells

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences,Tehran, Iran

Tehran, Iran

Location

Related Publications (2)

• Shokati A, Naser Moghadasi A, Nikbakht M, Sahraian MA, Mousavi SA, Ai J. A focus on allogeneic mesenchymal stromal cells as a versatile therapeutic tool for treating multiple sclerosis. Stem Cell Res Ther. 2021 Jul 13;12(1):400. doi: 10.1186/s13287-021-02477-5.

  PMID: 34256857 BACKGROUND

• Ebrahimi-Barough S, Ai J, Payab M, Alavi-Moghadam S, Shokati A, Aghayan HR, Larijani B, Arjmand B. Standard Operating Procedure for the Good Manufacturing Practice-Compliant Production of Human Endometrial Stem Cells for Multiple Sclerosis. Methods Mol Biol. 2021;2286:199-212. doi: 10.1007/7651_2020_281.

  PMID: 32504294 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdorreza Naser Moghadasi, MD

  Multiple Sclerosis Research Center,Neuroscience Institute,Sina Hospital,Tehran, Iran.

  STUDY DIRECTOR

• Mohsen Nikbakht, PhD

  Research Institute for Oncology, Hematology& Cell Therapy Facility, Shariati Hospital ,Tehran, Iran.

  STUDY DIRECTOR

• Ameneh Shokati, PhD

  Applied Cell Sciences,Tehran University of Medical Sciences,Tehran, Iran.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label phase 1, single-center, pre-post comparison study

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 11, 2024
• Study Start: July 23, 2019
• Primary Completion: March 4, 2024
• Study Completion: March 6, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)