Functional Neural Regeneration Collagen Scaffold Transplantation in Acute Spinal Cord Injury Patients

Study Overview
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Brief Summary
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The study is designed to assess the safety and efficacy of functional neural regeneration collagen scaffold transplanted into acute spinal cord injury patients.

Official Title
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Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation in Complete (AISA) Acute Spinal Cord Injury Patients

Conditions
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Acute Spinal Cord Injury

Intervention / Treatment
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* Biological: Functional collagen scaffold


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 (C4-T12). Classification ASIA A, occurring within past 21 days. 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: Functional collagen scaffold<br>Functional neural regeneration collagen scaffold transplantation. | Biological: Functional collagen scaffold<br>* Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery.<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 transplantation. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Electrophysiological monitoring | Somatosensory Evoked Potentials (SSEP) monitoring will be assessed before and after transplantation. | 12 months | 
| Improvements in Electrophysiological monitoring | Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation. | 12 months |