Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis
NCT ID: NCT06360861
Last Updated: 2024-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
5 participants
INTERVENTIONAL
2019-07-23
2024-03-06
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Placenta derived mesenchymal cells
Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection
Allogenic placenta derived mesenchymal stem cells
Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection.
Interventions
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Allogenic placenta derived mesenchymal stem cells
Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection.
Eligibility Criteria
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Inclusion Criteria
* Must be able to Sign informed consent .
* Currently taking Rituximab.
* Disease duration of more than 2 and less than 16 years.
Exclusion Criteria
* 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.
17 Years
45 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Abdorreza Naser Moghadasi, MD
Role: STUDY_DIRECTOR
Multiple Sclerosis Research Center,Neuroscience Institute,Sina Hospital,Tehran, Iran.
Mohsen Nikbakht, PhD
Role: STUDY_DIRECTOR
Research Institute for Oncology, Hematology& Cell Therapy Facility, Shariati Hospital ,Tehran, Iran.
Ameneh Shokati, PhD
Role: PRINCIPAL_INVESTIGATOR
Applied Cell Sciences,Tehran University of Medical Sciences,Tehran, Iran.
Locations
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Tehran University of Medical Sciences,Tehran, Iran
Tehran, , Iran
Countries
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References
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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.
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.
Other Identifiers
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IR.TUMS.MEDICINE.REC.1400.197
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1400-1-233-51589
Identifier Type: -
Identifier Source: org_study_id
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