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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Stem Cell Institute
Panama City, Panama
Number of patients with adverse events
12 and 52 weeks after final treatment
Time frame: 12 weeks, 52 weeks
Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline
12 and 52 weeks after final treatment
Time frame: 12 weeks, 52 weeks
Number of subjects with a change in Frankel Scale score from baseline
12 and 52 weeks from final treatment
Time frame: 12 weeks, 52 weeks
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