NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy and Safety of NeuroRegen Scaffold™ Combined With Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Biological: NeuroRegen scaffold/mesenchymal stem cells transplantation
* Biological: NeuroRegen scaffold/neural stem cells transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18-65 years old. Completely spinal cord injury at the cervical and thoracic level (C5-T12). Classification ASIA A with no significant further improvement. Patients signed informed consent. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures. Exclusion Criteria: 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). Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans). History of life threatening allergic or immune-mediated reaction. Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis). History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders. 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. Lactating and pregnant woman. Alcohol drug abuse /dependence. Participated in any other clinical trials within 3 months before the enrollment. A drug or treatment known to cause effect on the central nervous system during the past four weeks. A drug or treatment known to cause major organ system toxicity during the past four weeks. Poor compliance, difficult to complete the study. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroRegen scaffold/mesenchymal stem cells transplantation<br>Patients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury. | Biological: NeuroRegen scaffold/mesenchymal stem cells transplantation<br>* 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.<br>|
| Experimental: NeuroRegen scaffold/neural stem cells transplantation<br>Patients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury. | Biological: NeuroRegen scaffold/neural stem cells transplantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in Independence Measures | Functional Independence Measure (FIM) will be assessed before and after surgery. | 1, 3, 6, 12, 18 and 24 months | 
| Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI) | The MRI at the transplantation site will be assessed before and after transplantation. | 1, 3, 6, 12, 18 and 24 months | 
| Improvements in Urinary and Bowel Function | The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after surgery. | 1, 3, 6, 12, 18 and 24 months | 
| Safety and Tolerability assessed by Adverse Events | Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up. | Up to 6 months |