spinal cord injury
Conditions
Interventions
functional scaffold only:transplantation of functional scaffold only
functional scaffold seeded with low dose of mesenchymal stem cells:transplantation of functional scaffold seeded with low dose of mesenchymal stem cells
functional scaffold seeded with moderate dose of mesenchymal stem cells:transplantation of functional scaffold seeded with moderate dose of mesenchymal stem cells
functional scaffold seeded with high dose of mesenchymal stem cells:transplantation of functional scaffold seeded with high dose of mesenchymal stem cells
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. T1-11complete spinal cord injury (ASIA spinal cord injury assessment grade A, proved by electrophysiology test and MRI, injury level will be confirmed by physical examination); 2. The glial scar after spinal cord injury less than 2cm (proved by MRI); 3. Male or female aged 18-60 years with acute or subacute spinal cord injury (less than 3 months, ASIA grade A), no improvement after rehabilitation training; 4. Good muscle condition, function of peripheral nerves should be normal; 5. Good general condition,function of major organs should be normal; major laboratory examinations should be normal; 6. No brain diseases or psychological diseases; 7. Good compliance and knowledge level, have an objective understanding to the condition and prognosis of the disease.
Exclusion criteria
Exclusion criteria: 1. Combined with diseases that affect the recovery of spinal cord injury or rehabilitation training; 2. Non thoracic spinal cord injury; 3. Incomplete spinal cord injury or undefined injury site and range; 4. No rehabilitation training after spinal cord injury; 5. Muscle atrophy or fibrosis; 6. Degeneration of peripheral nerve; 7. Allergic constitution; 8. Received immunomodulator or experimental drug treatment 60 days before the research; 9. Severe background diseases, diabetes, autoimmune diseases, tumor or severe high blood pressure; 10. Poor general condition, malfunction of major organs, intolerance of surgery; 11. MODS, sepsis associated organ failure assessment score=12; 12. Routine laboratory examinations inadequate and at least 1 positive result of the blood test: HCV antibody, HIV antibody or HTLV-1 antibody; 13. Severe bleeding tendency or coagulation disorders; 14. surgical site inflammation or skin ulcer; 15. Pregnancy or lactation period; 16. Refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;blood routine examination;blood biochemistry examination;urine routine examination;blood coagulation examination;urinary sediment examination;stool OB examination;syphilis test;ECG;chest X-ray examination;psychological test;ASIA spinal cord injury assesment;motor score of key muncles;sensory score of key sites;function independent measure;electromyography;electrophysiology;MRI examination;urodynamic test;spasm;pain;gene analysis of blood sample;immune factors test of blood sample; | — |
Countries
China
Contacts
Public ContactLiming Cheng
Shanghai Tongji Hospital
Outcome results
None listed