This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury.
Phase I, open-label, single-site, safety study of HSSC transplantation for the treatment of chronic spinal cord injury (SCI). Group A enrolled 4 subjects with a cord injury at T2-T12; Group B will enroll 4 subjects with a C5-C7 cord injury. Study period will be 6 months post-operative. Post-study, subjects will be followed for an additional 54 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Human spinal cord stem cell implantation in paralysis patients due to a spinal cord injury.
UCSD Medical Center, Division of Neurosurgery
San Diego, California, United States
RECRUITINGAdverse events and clinically significant laboratory abnormalities
Time frame: 6 months
Graft survival in the transplant site as determined by MRI (for Group A) and via autopsy, if one is completed.
Effectiveness of immunosuppression as determined by absence of donor-specific HLA antibodies.
Time frame: Month 60
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