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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection.
Tehran University of Medical Sciences,Tehran, Iran
Tehran, Iran
Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability].
adverse events
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
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.
Time frame: 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
Time frame: Up to 6 months
Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging .
Assessment of brain connectivity
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 months
Proportion of patients with change in T2 lesion volume on brain MRI.
Change from baseline in T2 lesion volume.
Time frame: Up to 6 months
Proportion of patients with change in brain volume on MRI.
Change from baseline in brain volume
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Up to 6 months
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