Spinal cord injury
Conditions
Interventions
Group 1:Human neural stem cells (ANGE-S002) consist of 1.5 x 10^6 cells /2ml
Group 2:Human neural stem cells (ANGE-S002) consist of 5.0 x 10^6 cells /2ml
Group 3:Human neural stem cells (ANGE-S002) consist of 1.5 x 10^7 cells /2ml
Group 4:Human neural stem cells (ANGE-S002) consist of 5.0 x 10^7 cells /2ml
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients with spinal cord injury (ASIA grade A-D); 2. Patients with thoracic and lumbar spinal cord injuries; 3. No gender limit; 4. Aged 18-60 years; 5. Patients with non-acute injury (2 weeks to 1 year after injury); 6. Patients have good compliance, good cognitive level, and an objective understanding of the condition and recovery of the disease; 7. Ability to sign informed consent and related documents.
Exclusion criteria
Exclusion criteria: 1. Patients with spinal cord injury combined with brain injury; 2. Patients with non-traumatic spinal cord injury caused by other spinal cord diseases, including but not limited to spinal cord tumors, myelinitis, demyelination, and spinal vascular malformations; 3. Patients with ankylosing spondylitis; 4. Patients with neurological or psychiatric diseases; 5. Poor general condition, with serious heart, lung, liver, kidney or other major organ dysfunction; 6. Patients with serious underlying diseases, including but not limited to hypertension, diabetes, heart disease, cerebral infarction, autoimmune diseases, coagulation disorders or tumors; 7. Received immunomodulator therapy or experimental drug therapy within the previous 3 months; 8. Those who are not suitable for at least one positive serological test during routine laboratory examination: syphilis antibody, HBV antigen, HCV antibody, HIV antibody; 9. Have an active infection; 10. Pregnant or lactating patients; 11. Those who do not agree to sign the informed consent and related documents; 12. Those who have previously participated in other stem cell treatments; 13. Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American Spinal Injury Association total score;American Spinal Injury Association damage rating; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional independence assessment (FIM) scale;Modified Ashworth spasm scale (MSS);Electromyography detection;EEG detection;Imaging detection of spine and spinal cord; | — |
Countries
China
Contacts
Public ContactCheng Liming
Shanghai Tongji Hospital
Outcome results
None listed