Spinal Cord Injury
Conditions
Brief summary
The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and complete spinal cord injury, compared to the treatment of surgical intradural decompression and adhesiolysis only.
Interventions
BIOLOGICALNeuroRegen Scaffold with BMMCs transplantation
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
PROCEDURESurgical intradural decompression and adhesiolysis
Patients with chronic SCI (ASIA grade A) will receive intradural decompression and adhesiolysis surgery and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Sponsors
First Hospitals affiliated to the China PLA General Hospital
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 60 Years
Healthy volunteers
No
Inclusion criteria
1. Completely spinal cord injury at the thoracic level as assessed by magnetic resonance imaging (MRI) and electrophysiology. 2. ASIA Impairment Scale (AIS) grade A. 3. Male or female, 18-60 years old. 4. No significant further improvement after injury and rehabilitation. 5. Patients with normal peripheral nerve function and without muscle atrophy. 6. Cardiovascular, respiratory, liver, kidney functions and laboratory examinations are within normal ranges. 7. No brain disease or mental disorder. 8. Ability and willingness to regular visit to hospital and follow up during the protocol procedures. 9. Patients signed informed consent.
Exclusion criteria
1. A current diagnosis of any primary diseases affecting limb functions (e.g., traumatic brain injury, cerebral hemorrhage, cognitive disorders or other central nervous system diseases). 2. Patients without any rehabilitation train after injury. 3. Remarkable muscle atrophy or fibrosis. 4. Degeneration of peripheral nerve function. 5. Allergic constitution. 6. Participation in any immunomodulator therapy or experimental drug treatment within 60 days prior to study. 7. Suffering diabetes, autoimmune diseases, tumor or severe hypertension. 8. Patients with severe heart, lung, liver or renal dysfunction are unable to meet the surgery standards. 9. Severe bleeding tendency or abnormal coagulation function. 10. Inflammation or skin ulcers at the surgical site. 11. Lactating and pregnant woman. 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. |
| Magnetic Resonance Imaging (MRI) | 1, 3, 6, 12, 18 and 24 months | The change of treated spinal cord injury will be assessed by Magnetic Resonance Imaging (MRI) before and after surgery. |
| 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