The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical cord blood mononuclear cell transplant, and the combination in the treatment of acute and subacute spinal cord injury
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
250mg/tablet, administrated orally for 6 weeks.
Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site
Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital
Kunming, Yunnan, China
Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks
Time frame: Week 0, 1, 2, 6, 14, 24 and 48
Walking
Walking Index of Spinal Cord Injury (WISCI)
Time frame: Week 2, 6, 14, 24, 48
Functional assessment
Spinal Cord Injury Measure (SCIM) Score
Time frame: Week 2, 6, 14, 24, 48
Locomotion
Kunming locomotor scales
Time frame: Week 2, 6, 14, 24, 48
Spasticity grade
Modified Ashworth Scale
Time frame: Week 2, 6, 14, 24, 48
Pain
Numerical rating scales
Time frame: Week 2, 6, 14, 24, 48
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Placebo tablet, orally administration of placebo for 6 weeks