Traumatic subacute spinal cord injury
Conditions
Interventions
Transplantation group:Intraspinal injection of umbilical cord mesenchymal stem cells+Rehabilitation
Sponsors
Xi 'an GaoXin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18-65; 2. Suffering from traumatic spinal cord injury; 3. Clinical diagnosis of complete or incomplete cervical spinal cord injury, ASIA grade A or B, imaging shows that the length of the cavity/thinning in the injured area is less than 2 cm; 4. 2 weeks to 2 months after injury,there are indications for spinal cord decompression or internal fixation; 5. Able to understand various questions of the test and provide reliable information; 6. The subjects must voluntarily sign their names and dates on the informed consent form. If the subject agrees to participate but is unable to sign and date the informed consent form due to his/her medical condition, consent must be verbal, signed by the subject's relative, and an impartial witness involved in the entire informed consent process; 7. Agree to follow up regularly for at least 2 year after the end of treatment.
Exclusion criteria
Exclusion criteria: 1. Those who cannot tolerate surgery: including but not limited to those with severe cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, blood coagulation abnormalities, mental disorders and cancer; 2. Brain injury with loss of neurological function; 3. It is expected that other surgical treatments will be required during the study period; 4. Pregnant or breastfeeding women, or women who may become pregnant during the trial period but are unwilling to use effective contraceptive measures; 5. Participated in other clinical research in the past three months, or participated in other clinical research related to spinal cord injury; 6. People with abnormal immune function, such as severe allergic diseases and autoimmune diseases; 7. Patients with high cervical spinal cord injury and unable to breathe on their own; 8. For various reasons, the researcher believes that the subject is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event rate;The difference between post-treatment ISNCSCI value and enrollment screening ISNCSCI value.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight and vital signs;Blood index;Routine urine test;General physical examination;ECG;VAS score;Co-treatment records;Ashworth muscle tone;PHQ-9;Residual urine volume;PGIC;Frankel classification;Electromyography and somatosensory evoked potentials;MRI of injury site; | — |
Countries
China
Contacts
Public ContactHe Xijing
Xi 'an GaoXin Hospital
Outcome results
None listed