NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NeuroRegen Scaffold with BMMCs or MSCs transplantation
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Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
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Outcome Measures
Primary Outcome Measures
- Safety Evaluation Number of patients with adverse events [6 months]
Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold with MSCs transplantation.
Secondary Outcome Measures
- Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed [12 months]
Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.
- Improvements in ASIA Impairment Scale [12 months]
American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation.
- Improvements in Independence Measures and Quality of Life [12 months]
Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation.
- Improvements in Pain assessed based on Visual analog scale (VAS) [12 months]
Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation.
- Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation [12 months]
The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation.
- Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI) [12 months]
The MRI at the transplantation site will be assessed before and after transplantation.
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 | First Hospitals affiliated to the China PLA General Hospital | Beijing | China | 100037 | |
| 2 | The First Affiliated Hospital of Soochow University | Suzhou | China | 215006 | |
| 3 | Affiliated Hospital of Logistics Universtiy of CAPF | Tianjin | China | 300162 |
Sponsors and Collaborators
- Chinese Academy of Sciences
- Affiliated Hospital of Logistics University of CAPF
- The First Affiliated Hospital of Soochow University
- First Hospitals affiliated to the China PLA General Hospital
Investigators
- Principal Investigator: Jianwu Dai, Ph.D, Chinese Academy of Sciences
- Study Chair: Sai Zhang, M.D, Affiliated Hospital of Logistics Universtiy of CAPF
- Study Chair: Huilin Yang, Ph.D, The First Affiliated Hospital of Soochow University
- Study Chair: Shuxun Hou, First Hospitals affiliated to the China PLA General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAS-XDA-SCI/IGDB