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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02237547
Study type Interventional
Source Translational Biosciences
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date September 2014
Completion date October 2019

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