The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
First Hospitals affiliated to the China PLA General Hospital
Beijing, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, China
Safety Evaluation Number of patients with adverse events
Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold with MSCs transplantation.
Time frame: 6 months
Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed
Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.
Time frame: 12 months
Improvements in ASIA Impairment Scale
American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation.
Time frame: 12 months
Improvements in Independence Measures and Quality of Life
Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation.
Time frame: 12 months
Improvements in Pain assessed based on Visual analog scale (VAS)
Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation.
Time frame: 12 months
Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation
The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation.
Time frame: 12 months
Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)
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The MRI at the transplantation site will be assessed before and after transplantation.
Time frame: 12 months