Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord With Lithium Carbonate or Placebo Followed by Locomotor Training

Summary

Participation Requirements

Description

This study is a randomized controlled, Phase II, three-arm study of Umbilical Cord Blood Mononuclear Cell (MC001) transplant into the injured spinal cord in combination with either 6-week course of oral lithium carbonate or placebo followed by the locomotor training for up to 6 hours a day, 6 days a...

This study is a randomized controlled, Phase II, three-arm study of Umbilical Cord Blood Mononuclear Cell (MC001) transplant into the injured spinal cord in combination with either 6-week course of oral lithium carbonate or placebo followed by the locomotor training for up to 6 hours a day, 6 days a week, for 3-6 months. A total of 27 subjects with chronic complete spinal cord injury (SCI) will be randomized to one of the three treatment groups. The subjects assigned to Group A and B will receive 6.4 million UCBMNC (MC001) transplanted into the dorsal root entry zones above and below the injury site exposed by a laminectomy. Subjects in Group A and B will be treated with oral lithium carbonate or placebo for six weeks in a double blind manner. All subjects will receive 3-6 months of intensive locomotor training.

Tracking Information