Spinal Cord Injury
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury.
Interventions
BIOLOGICALNeuroRegen scaffold/mesenchymal stem cells transplantation
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million mesenchymal stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
BIOLOGICALNeuroRegen scaffold/neural stem cells transplantation
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million neural stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Sponsors
Affiliated Hospital of Logistics University of CAPF
Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, 18-65 years old. 2. Completely spinal cord injury at the cervical and thoracic level (C5-T12). 3. Classification ASIA A with no significant further improvement. 4. Patients signed informed consent. 5. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Exclusion criteria
1. A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease). 2. Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans). 3. History of life threatening allergic or immune-mediated reaction. 4. Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis). 5. History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders. 6. Severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG. 7. Lactating and pregnant woman. 8. Alcohol drug abuse /dependence. 9. Participated in any other clinical trials within 3 months before the enrollment. 10. A drug or treatment known to cause effect on the central nervous system during the past four weeks. 11. A drug or treatment known to cause major organ system toxicity during the past four weeks. 12. Poor compliance, difficult to complete the study. 13. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvements in ASIA (American Spinal Injury Association) Impairment Scale | 24 months |
| Improvements in Somatosensory Evoked Potentials (SSEP) | 24 months |
| Improvements in Motor Evoked Potentials (MEP) | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvements in Independence Measures | 1, 3, 6, 12, 18 and 24 months | Functional Independence Measure (FIM) will be assessed before and after surgery. |
| Safety and Tolerability assessed by Adverse Events | Up to 6 months | Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up. |
| Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI) | 1, 3, 6, 12, 18 and 24 months | The MRI at the transplantation site will be assessed before and after transplantation. |
| Improvements in Urinary and Bowel Function | 1, 3, 6, 12, 18 and 24 months | The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after surgery. |
Countries
China
Outcome results
None listed