The study is designed to assess the safety and efficacy of functional neural regeneration collagen scaffold transplanted into acute spinal cord injury patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery.
First Hospitals affiliated to the China PLA General Hospital
Beijing, China
RECRUITINGXinqiao Hospital of Army Medical University
Chongqing, China
RECRUITINGThe First Affiliated Hospital of Soochow University
Suzhou, 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 transplantation.
Time frame: 6 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 Electrophysiological monitoring
Somatosensory Evoked Potentials (SSEP) monitoring will be assessed before and after transplantation.
Time frame: 12 months
Improvements in Electrophysiological monitoring
Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, China
RECRUITINGGeneral Hospital of Ningxia Medical University
Yinchuan, China
RECRUITING