Spinal cord injury
Conditions
Interventions
Group 1:Prospective cohort of acute spinal cord injury
Group 2:Stem cells transplantation
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Prospective cohort study: (1) Patients with spinal cord injury in acute stage (within 2 weeks); (2) Aged 15 years and above. 2. Pilot randomized controlled trials: (1) Age between 15-65 years old, no gender restriction, body mass index (BMI) between 19-25kg/m2 (BMI=weight (Kg)/height (m) squared), including boundary values; (2) Sensory or motor deficits below the level of injury; (3) Have not received stem cell therapy within the last 6 months; (4) The subjects themselves or their families can sign the informed consent form in accordance with the research procedures and instructions.
Exclusion criteria
Exclusion criteria: 1. Prospective cohort study: (1) Patients with previous neuromuscular disease; (2) Spinal cord injury caused by tumors and other factors; (3) Patients with mental illness; (4) Patients who cannot cooperate with the completion of medical history collection, biological sample sampling and follow-up. 2. Pilot randomized controlled trials: (1) Only nerve root injury symptoms; (2) only symptoms of cauda equina injury; (3) Mean arterial pressure (MAP) is less than 60mmHg; (4) Glasgow score less than 13 points; (5) Women who are pregnant, breastfeeding or planning to become pregnant; (6) The patient has a history of medical diseases with potential risks: history of diabetes, history of severe cardiovascular disease, severe infection foci, history of gastrointestinal bleeding, etc.; (7) Serum HIV antibody positive and syphilis antibody positive; (8) Other serious systemic or organ diseases; (9) The investigator believes that there are patients who cannot be included in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI);Complication;Death;Feasibility related indicators of definitive randomised controlled trials;Outcomes of spinal cord injury; | — |
Countries
China
Contacts
Public ContactZhou Hengxing
Qilu Hospital of Shandong University
Outcome results
None listed