Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis
- Conditions
- Secondary-Progressive Multiple SclerosisMultiple SclerosisMesenchymal Stem Cells
- Interventions
- Biological: Allogenic placenta derived mesenchymal stem cells
- Registration Number
- NCT06360861
- Lead Sponsor
- Tehran University of Medical Sciences
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placenta derived mesenchymal cells Allogenic placenta derived mesenchymal stem cells Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection
- Primary Outcome Measures
Name Time Method Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability]. Up to 6 months adverse events
- Secondary Outcome Measures
Name Time Method Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging . Up to 6 months Assessment of brain connectivity
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 Assessment of cognitive function
Proportion of patients with change in CD20 / CD19 B cells surface markers Up to 3 months Blood samples will be collected pre and post treatment for immediate or ulterior analysis.
Proportion of patients for psychological assessment as measured by the validated Persian version of Symptom Checklist-90-Revised . Up to 6 months 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.
Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging . Up to 6 months Change from baseline in white matter integrity
Proportion of patients with change in brain volume on MRI. Up to 6 months Change from baseline in brain volume
Proportion of patients for assessment of visuospatial ability as measured by the California Verbal Learning Test Second Edition test. Up to 6 months Change from baseline in visuospatial ability
Biological Assessments including IL-10, IL-6, IL-17, and TNFα levels of cytokines. Up to 3 months Blood samples will be collected pre and post treatment for immediate or ulterior analysis.
Proportion of patients with change in T2 lesion volume on brain MRI. Up to 6 months Change from baseline in T2 lesion volume.
Proportion of patients for assessment of visuospatial ability as measured by Judgment of Line Orientation Test . Up to 6 months Change from baseline in visuospatial ability
Proportion of patients for measuring verbal fluency as measured by the Controlled Oral Word Association Test . Up to 6 months Change from baseline in measuring verbal fluency
Proportion of patients for assessment of visuospatial ability as measured by the brief visuospatial memory test-revised test. Up to 6 months Change from baseline in visuospatial ability
Number of participants with a change in disability as measured by Expanded Disability Status Scale . Up to 6 months 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.
Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test . Up to 6 months The minimum score is 0 and maximum score is 60, and higher scores mean a better outcome.
Number of participants with evaluation of verbal learning and memory deficits as measured by the California Verbal Learning Test second edition . Up to 6 months Change from baseline in verbal learning and memory deficits and higher scores mean a better outcome.
Proportion of patients for evaluation of executive functions as measured by the Delis-Kaplan Executive Function System Sorting and descriptive tests. Up to 6 months Change from baseline in executive functions
Number of participants with a change in processing and motor speed as assessed by the Symbol Digit Modalities Test . Up to 6 months Change from baseline in processing and motor speed of patients and higher scores mean a better outcome.
Proportion of patients for assessment of visuospatial learning as measured by the Brief Visuospatial Memory Test-Revised . Up to 6 months Change from baseline in visuospatial learning
Proportion of patients for evaluation of fatigue as measured by was examined by the Persian version of Fatigue Severity Scale . Up to 6 months 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.
Trial Locations
- Locations (1)
Tehran University of Medical Sciences,Tehran, Iran
🇮🇷Tehran, Iran, Islamic Republic of