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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Active ingredients: Monocytes, CD34+, CD133+ cells Dose: 4 injections of 16-μliter (100,000 cells/μliter)
Locomotor training for up to 6 hours a day, 6 days a week, and for 3-6 months
Hualien Tzu Chi Hospital
Hualien City, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Walking Index of Spinal Cord Injury (WISCI II) Overall Measure
The primary endpoint for this study is mean change from baseline of the Walking Index of Spinal Cord Injury (WISCI II).
Time frame: At Week 48.
Walking Index of Spinal Cord Injury Measure (WISCI II) at Week 6 and 28
Mean change from baseline of the Walking Index of Spinal Cord Injury (WISCI II).
Time frame: At Week 6 and 28.
Spinal Cord Independence Measure (SCIM III)
Mean change from baseline of Spinal Cord Independence Measure (SCIM III)
Time frame: At Week 6, 28, and 48.
Measure of American Spinal Injury Association (ASIA) Motor and Sensory Scores and AIS Grade
American Spinal Injury Association (ASIA) score has three components: (1) Sensory scores: There is a maximum total of 56 points each for light touch and pin prick (sharp/dull discrimination) modalities, for a total of 112 points per side of the body. (2) Motor scores: There is a maximum score of 25 for each extremity, totaling 50 for the upper limbs and 50 for the lower limbs. (3) ASIA Impairment Scale: Injuries are classified in general terms of being neurologically "complete" or "incomplete" based upon the sacral sparing definition.
Time frame: At Week 2, 6, 28, and 48.
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