The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million mesenchymal stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million neural stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, China
Improvements in ASIA (American Spinal Injury Association) Impairment Scale
Time frame: 24 months
Improvements in Somatosensory Evoked Potentials (SSEP)
Time frame: 24 months
Improvements in Motor Evoked Potentials (MEP)
Time frame: 24 months
Improvements in Independence Measures
Functional Independence Measure (FIM) will be assessed before and after surgery.
Time frame: 1, 3, 6, 12, 18 and 24 months
Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI)
The MRI at the transplantation site will be assessed before and after transplantation.
Time frame: 1, 3, 6, 12, 18 and 24 months
Improvements in Urinary and Bowel Function
The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after surgery.
Time frame: 1, 3, 6, 12, 18 and 24 months
Safety 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
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