The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and complete spinal cord injury, compared to the treatment of surgical intradural decompression and adhesiolysis only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) 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 intradural decompression and adhesiolysis surgery and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
First Affiliated Hospital of PLA General Hospital
Beijing, 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
Magnetic Resonance Imaging (MRI)
The change of treated spinal cord injury will be assessed by Magnetic Resonance Imaging (MRI) before and after surgery.
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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