NeuroRegen Scaffold™ 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 safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.

Official Title
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Safety and Efficacy of NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells or Mesenchymal 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 with BMMCs or MSCs 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroRegen Scaffold with BMMCs or MSCs transplantation<br> | Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluation Number of patients with adverse events | Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold with MSCs transplantation. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed | Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation. | 12 months | 
| Improvements in ASIA Impairment Scale | American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation. | 12 months | 
| Improvements in Independence Measures and Quality of Life | Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation. | 12 months | 
| Improvements in Pain assessed based on Visual analog scale (VAS) | Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation. | 12 months | 
| Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation | The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation. | 12 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. | 12 months |