The study is designed to assess the role of functional neural regeneration collagen scaffold transplantation combined with epidural electrical stimulation in spinal cord injury patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Participants had finished the previous clinical trial with functional neural regeneration collagen scaffold transplantation, and will receive epidural electrical stimulation of the spinal cord in this group.
Participants with acute complete SCI or chronic complete SCI will receive functional neural regeneration scaffold transplantation and epidural electrical stimulation of the spinal cord.
Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, China
RECRUITINGSafety and Tolerability assessed by Adverse Events
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up
Time frame: Up to 6 months
Change in ASIA Impairment Scale
American Spinal Injury Association Impairment Scale of A, B, C, D or E will be assessed before and after transplantation.
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in ASIA motor score
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Functional Independence Measure (FIM)
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Somatosensory Evoked Potentials (SSEP) monitoring
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Motor Evoked Potentials (MEP) monitoring
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Walking Speed
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Stride length
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
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