To investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal cord injuries.
This is an open-label, dose-escalating clinical trial. Three groups of four patients will receive transplants of increasing doses of HLA-matched umbilical cord blood mononuclear cell into the spinal cord. In the fourth group, we will transplant the highest volume of cells that did not increase neurological deficits along with a single bolus of 30mg/kg methylprednisolone sodium succinate. In the fifth group of four subjects, we will inject that volume of cells plus a bolus intravenous dose of 30mg/kg methylprednisolone sodium succinate and a 6-week course of oral lithium carbonate titrated to 0.6-1.0 mM serum levels. All the subjects are encouraged to stand or walk for one hour a day after the cell transplantation. The neurological and walking outcomes will be assessed 1, 2, 6, 24 and 48 weeks after transplantation. The outcomes of the five treatment groups will be compared by analysis of variance and, if possible, correlation with cell dose. Efficacy and safety will be analyzed comparing neurological change scores amongst the five different treatment groups. Loss of motor (\>5 points) or sensor scores (\>2 points) from baseline pre-treatment levels would be considered deleterious. Increases in scores above baseline would be considered beneficial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The cord blood mononuclear cells are obtained from thawed units of HLA-matched human umbilical cord blood. The cells will be slowly injected into the posterior gray matter after laminectomy and opening of the dura.
30 mg/kg methylprednisolone
oral lithium, titrated to maintain 0.6-1.0 mM serum level
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
ASIA motor scores and sensory scores
Time frame: 0, 1, 2, 6 24 and 48 weeks
ASIA Impairment Scale grade
Time frame: 0, 1, 2, 6 24 and 48 weeks
MRI and Diffusion Tensor Imaging of spinal cord
Time frame: 0, 1, 24 and 48 weeks
Spinal Cord Independence Measure (SCIM) score
Time frame: 0, 6, 24 and 48 weeks
Walking Index of Spinal Cord Injury (WISCI) level
Time frame: 0, 6, 24 and 48 weeks
Modified Ashworth Scale (MAS) of Spasticity
Time frame: 0, 1, 2, 6, 24 and 48 weeks
Visual Analog Scale (VAS) of pain
Time frame: 0, 1, 2, 6, 24 and 48 weeks
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