NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NeuroRegen scaffold/mesenchymal stem cells transplantation Patients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury. |
Biological: NeuroRegen 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.
|
| Experimental: NeuroRegen scaffold/neural stem cells transplantation Patients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury. |
Biological: NeuroRegen 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Improvements in Independence Measures [1, 3, 6, 12, 18 and 24 months]
Functional Independence Measure (FIM) will be assessed before and after surgery.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, 18-65 years old.
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Completely spinal cord injury at the cervical and thoracic level (C5-T12).
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Classification ASIA A with no significant further improvement.
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Patients signed informed consent.
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Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Exclusion Criteria:
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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).
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Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
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History of life threatening allergic or immune-mediated reaction.
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Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
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History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
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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.
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Lactating and pregnant woman.
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Alcohol drug abuse /dependence.
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Participated in any other clinical trials within 3 months before the enrollment.
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A drug or treatment known to cause effect on the central nervous system during the past four weeks.
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A drug or treatment known to cause major organ system toxicity during the past four weeks.
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Poor compliance, difficult to complete the study.
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Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Affiliated Hospital of Logistics Universtiy of CAPF | Tianjin | China | 300162 |
Sponsors and Collaborators
- Chinese Academy of Sciences
- Affiliated Hospital of Logistics University of CAPF
Investigators
- Principal Investigator: Jianwu Dai, Ph.D, Chinese Academy of Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAS-XDA-MNSCI/IGDB