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| ID | Type | Description | Link |
|---|---|---|---|
| IR.TUMS.MEDICINE.REC.1400.197 | Other Grant/Funding Number | Tehran University of Medical Sciences |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placenta derived mesenchymal cells | Experimental | Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogenic placenta derived mesenchymal stem cells | Biological | Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability]. | adverse events | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a change in disability as measured by Expanded Disability Status Scale . | Proportion of patients with clinical improvement in EDSS score compared to baseline. EDSS scores range from 0 = no disability to 10 = death due to MS and higher scores mean a worse outcome. | Up to 6 months |
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Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran University of Medical Sciences,Tehran, Iran | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34256857 | Background | 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. | |
| 32504294 | 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. |
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Open-label phase 1, single-center, pre-post comparison study
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| Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test . |
The minimum score is 0 and maximum score is 60, and higher scores mean a better outcome. |
| 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. | Assessment of cognitive function | Up to 6 months |
| Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging . | Assessment of brain connectivity | Up to 6 months |
| Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging . | Change from baseline in white matter integrity | Up to 6 months |
| Number of participants with a change in processing and motor speed as assessed by the Symbol Digit Modalities Test . | Change from baseline in processing and motor speed of patients and higher scores mean a better outcome. | Up to 6 months |
| Number of participants with evaluation of verbal learning and memory deficits as measured by the California Verbal Learning Test second edition . | Change from baseline in verbal learning and memory deficits and higher scores mean a better outcome. | Up to 6 months |
| Proportion of patients with change in CD20 / CD19 B cells surface markers | Blood samples will be collected pre and post treatment for immediate or ulterior analysis. | Up to 3 months |
| Biological Assessments including IL-10, IL-6, IL-17, and TNFα levels of cytokines. | Blood samples will be collected pre and post treatment for immediate or ulterior analysis. | Up to 3 months |
| Proportion of patients with change in T2 lesion volume on brain MRI. | Change from baseline in T2 lesion volume. | Up to 6 months |
| Proportion of patients with change in brain volume on MRI. | Change from baseline in brain volume | Up to 6 months |
| Proportion of patients for assessment of visuospatial learning as measured by the Brief Visuospatial Memory Test-Revised . | Change from baseline in visuospatial learning | Up to 6 months |
| Proportion of patients for assessment of visuospatial ability as measured by Judgment of Line Orientation Test . | Change from baseline in visuospatial ability | Up to 6 months |
| Proportion of patients for evaluation of executive functions as measured by the Delis-Kaplan Executive Function System Sorting and descriptive tests. | Change from baseline in executive functions | Up to 6 months |
| Proportion of patients for measuring verbal fluency as measured by the Controlled Oral Word Association Test . | Change from baseline in measuring verbal fluency | Up to 6 months |
| Proportion of patients for psychological assessment as measured by the validated Persian version of Symptom Checklist-90-Revised . | Symptom Checklist-90(SCL-90) is a collection of nine subscales (with 90 items) for evaluation of Somatization, Obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism in the past week. Each item has a 5-point Likert scale and scoring from 0 to 4. SCL-90 Global Severity was calculated by dividing the sum of all subscales scores by 9. | Up to 6 months |
| Proportion of patients for evaluation of fatigue as measured by was examined by the Persian version of Fatigue Severity Scale . | Fatigue Severity Scale(FSS )is a scale with 9 items, which assesses the fatigue severity in the past 2 weeks. Each item has a score from 1 to 7 and total score will be from 9 to 63. Higher FSS score indicates higher fatigue severity. | Up to 6 months |
| Proportion of patients for assessment of visuospatial ability as measured by the brief visuospatial memory test-revised test. | Change from baseline in visuospatial ability | Up to 6 months |
| Proportion of patients for assessment of visuospatial ability as measured by the California Verbal Learning Test Second Edition test. | Change from baseline in visuospatial ability | Up to 6 months |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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