Spinal Cord Injury Clinical Trial
Official title:
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.
The proposed study will assess primary safety and secondary efficacy endpoints of autologous
bone marrow mononuclear cells and allogeneic human umbilical cord-derived mesenchymal stem
cells administered to 20 male and female subjects between ages of 18-50 with spinal cord
injury. These cells will be administered intrathecally and intravenously multiple times over
the course of one month.
The primary objective is freedom from treatment-associated adverse events at 3 and 12 months
post-treatment. Secondary objective will be efficacy at baseline, 3 months and 12 months and
will be quantified based on the following: American Spinal Cord Injury Association (ASIA)
classification and the Frankel Scale.
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