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Umbilical Cord Blood Cell (MC001) Transplant Into Injured Spinal Cord Followed by the Locomotor Training

Spinal Cord Injuries Clinical Trial

Official title:
A Randomized Controlled Phase II, Two-Arm Study of Umbilical Cord Blood Cell Transplant (MC001) Into Injured Spinal Cord Followed by the Locomotor Training for Patients With Chronic Complete Spinal Cord Injuries (SCI).

Clinical Trial Summary

Umbilical cord blood mononuclear stem cells (UCBMSCs) transplant followed by the intensive locomotor training for up to 5±1 hours a day, 5±1 days a week, and for 3-6 months for treatment in patients with chronic, stable and complete spinal cord injury.

Clinical Trial Description

This study is a randomized controlled, Phase II, two-arm study of Umbilical Cord Blood Mononuclear Cell (MC001) transplant into the injured spinal cord followed by the locomotor training for up to 5±1 hours a day, 5±1 days a week, for 3-6 months. A total of 18 subjects with chronic complete spinal cord injury (SCI) will be randomized to one of the two groups. The subjects assigned to Group A 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 B will not have MC001 transplant or surgery. All subjects will receive 3-6 months of intensive locomotor training. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03979742
Study type Interventional
Source StemCyte International, Ltd.
Contact Bobo Chen, PhD
Phone 886 2 2655 8558
Email us105d@stemcyte.com.tw
Status Recruiting
Phase Phase 2
Start date February 22, 2022
Completion date March 31, 2027
View Details
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