Spinal cord injury
Conditions
Interventions
The experimental group:On the basis of conventional treatment, nerve regeneration collagen scaffold and stem cell implantation intervention were added.
The control group:Routine decompression for spinal cord injury
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years, male or female; 2. C6-T12 spinal cord injury, including traumatic spinal cord injury and old iatrogenic spinal cord injury; 3. After spinal cord injury, the symptoms were not significantly improved during the observation period, and the ASIA grade was maintained at A or B (the longest observation period was 72 hours in the acute phase and 3 months in the chronic phase). 4. Physical examination of the nervous system, MRI(including DTI) and electrophysiological examination all confirmed spinal cord injury; 5. Subjects and their families informed and agreed to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients with diseases affecting the recovery of spinal cord injury or rehabilitation training (such as brain injury, cerebral hemorrhage, cognitive impairment, other central nervous system diseases, etc.); 2. Incomplete spinal cord injury or the location and size of spinal cord injury are difficult to be determined; 3. Peripheral nerve function degeneration; 4. Combined with severe craniocerebral trauma, thoracic and abdominal trauma, urinary system and limb joint trauma; 5. Those who were treated with immunomodulators or experimental drugs 60 days before the study were included in the study; 6. There are serious underlying diseases, such as diabetes, autoimmune diseases, tumors or severe hypertension, etc.; 7. Multiple organ failure, sepsis-related organ failure score >= 12; routine laboratory tests are not suitable and at least one of the following serological tests are positive: HBs antigen, HCV antibody, HIV antibody or HTLV-1 (human T-cell lymphovirus type I) antibody; 8. Severe bleeding tendency or coagulation dysfunction; 9. Inflammation or skin ulcer at the site of the proposed operation; 10. Pregnant or lactating women; 11. Spinal cord injury has been surgically treated in the past; 12. Patients with intraspinal tumors were confirmed by enhanced MRI that the tumors were not completely removed; 13. Patients who participated in other clinical trials within 3 months; 14. Patients with diseases affecting bone marrow puncture, such as the puncture site ulcers, severe anemia or other uncured blood system diseases; 15. Other criteria considered unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurological examination;Neuroelectrophysiological test;Neuroimaging;Functional Independence Rating and Grading (FIM); | — |
Countries
China
Contacts
Public ContactZhao Jizong
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed