Multiple Sclerosis Clinical Trial
Official title:
Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS) patients.
The proposed study will assess primarily safety and secondary efficacy endpoints of
allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 20 patients with
MS.
The primary objective of the trial is freedom from treatment associated adverse events at
4,12 and 52 weeks post treatment. Secondary objective will be efficacy as assessed at
baseline, week 12 and 52 and will be quantified based on the following: Neurological
assessment of the MS functional composite assessment which comprises of Expanded Disability
Status Scale (EDSS), the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis,
the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the
nine-hole peg test, and 25-foot walking time. Short-form 36 (SF-36) quality of life
questionnaire and gadolinium enhanced MRI scans of the brain and cervical spinal cord will
also be performed at the indicated time points.
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