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Chronic Graft Versus Host Disease

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

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

Allogenic placenta derived mesenchymal stem cells

Abdorreza Naser Moghadasi, MD

Mohsen Nikbakht, PhD

Ameneh Shokati, PhD

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.

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

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

An Open-label, Non-randomized, Phase I Study of Allogeneic Placenta Derived Mesenchymal Stem Cells in Patients With Secondary-Progressive Multiple Sclerosis (SPMS),

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.

The minimum score is 0 and maximum score is 60, and higher scores mean a better outcome.

Change from baseline in white matter integrity

Change from baseline in processing and motor speed of patients and higher scores mean a better outcome.

Change from baseline in verbal learning and memory deficits and higher scores mean a better outcome.

Blood samples will be collected pre and post treatment for immediate or ulterior analysis.

Change from baseline in T2 lesion volume.

Change from baseline in visuospatial learning

Change from baseline in visuospatial ability

Change from baseline in executive functions

Change from baseline in measuring verbal fluency

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.

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.

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