spinal cord injury
Conditions
Interventions
Intervention group:Patients undergo intravenous infusion of umbilical cord blood mononuclear cells within 2 weeks after surgery when vital signs are stable. The first infusion should be completed with
control group:Patients were selected for intravenous infusion of a placebo with the same or substantially similar appearance, color, and dosage as the umbilical cord blood mononuclear cells within 2
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years old, gender is not limited. 2. Acute spinal cord injury (ASIA grade A-C), not more than 2 weeks after the completion of early surgical treatment. 3. Liver and renal function is not obviously abnormal: ALT, AST = 2.5 times the upper limit of normal, serum Cr and BUN = 1.25 times the upper limit of normal. 4. Cardiorespiratory function is not obvious abnormalities. 5. No immune system diseases. 6. Sign the informed consent under the premise of full informed compliance with the patient's wishes.
Exclusion criteria
Exclusion criteria: 1.Patients with spinal cord injuries of more than 2 segments and unstable vital signs. 2. Patients with combined craniocerebral injuries and neurological symptoms. 3. Patients with previous extraspinal neurological or other neuromuscular disorders. 4. Patients with combined malignant tumors or other major systemic diseases. 5. Patients with severe active infections, or known HIV-positive patients, or patients with Hepatitis B or C and patients with syphilis. 6. Patients with multiple injuries with severe trauma to other organs that may affect the subsequent safety evaluation. 7. Pregnant or breastfeeding women, women of gestational age are required to use effective contraception, with the consent of their partner, prior to and during participation in the study as well as for 6 months after the completion of the study. Participants should notify the physician in charge if they suspect pregnancy during the study. 8. Patients with allergic reactions to the drugs used in the study or similar drugs. 9. Patients who are participating in other clinical trials. 10. Other patients who are considered by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American Spinal Injury Association impairment scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Spinal Cord Independence Measure;EMS;Waiking Index for Spinal Cord Injury;Magnetic Resonance Imaging;Computed Tomography ; | — |
Countries
China
Contacts
Public ContactJin Fan
Jiangsu Province Hospital
Outcome results
None listed