Functional Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair

Study Overview
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Brief Summary
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The study is designed to assess the role of functional neural regeneration collagen scaffold transplantation combined with epidural electrical stimulation in spinal cord injury patients.

Official Title
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Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Epidural Electrical Stimulation
* Combination Product: Functional scaffold & Epidural Electrical Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The enrolled participants are divided into three categories: Participants had complete functional scaffold transplantation in previous study and had motor functional recovery Participants With Acute Complete SCI: (1) Classification ASIA A, occurring within past 14 days; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) No serious complications Participants With Chronic Complete SCI: (1) Classification ASIA A, greater than 6 months post injury and no significant further improvement within past 3 months; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) Peripheral nervous system in good condition; (4) No serious complications Inclusion Criteria For All The Participants Men or non-pregnant women, 18-60 years old Ability and willingness to regular visit to hospital and follow up during the protocol Procedures Accompanied by a family member Signed informed consent Exclusion Criteria: Obvious muscle atrophy or fibrosis Decline in peripheral nerve function A current diagnosis of diseases affecting spinal cord injury recovery or rehabilitation training (e.g., brain injury, cerebral hemorrhage, cognitive impairment, other central nervous system diseases) Having serious health problems, (e.g., cardiovascular disease, diabetes, autoimmune diseases, tumors or severe hypertension) or serious complications (e.g. severe bedsores, pulmonary infection, respiratory disorders) Pregnancy or lactation History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders No family member accompany or can not get in touch with family members Poor compliance, difficult to complete the study Any other conditions that might increase the risk of participants or interfere with the clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural Electrical Stimulation<br> | Device: Epidural Electrical Stimulation<br>* Participants had finished the previous clinical trial with functional neural regeneration collagen scaffold transplantation, and will receive epidural electrical stimulation of the spinal cord in this group.<br>|
| Experimental: Functional scaffold & Epidural Electrical Stimulation<br> | Combination Product: Functional scaffold & Epidural Electrical Stimulation<br>* Participants with acute complete SCI or chronic complete SCI will receive functional neural regeneration scaffold transplantation and epidural electrical stimulation of the spinal cord.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in ASIA Impairment Scale | American Spinal Injury Association Impairment Scale of A, B, C, D or E will be assessed before and after transplantation. | Baseline, 1, 3 , 6, 12 and 24 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ASIA motor score |  | Baseline, 1, 3 , 6, 12 and 24 months post-treatment | 
| Change in Functional Independence Measure (FIM) |  | Baseline, 1, 3 , 6, 12 and 24 months post-treatment | 
| Change in Somatosensory Evoked Potentials (SSEP) monitoring |  | Baseline, 1, 3 , 6, 12 and 24 months post-treatment | 
| Change in Motor Evoked Potentials (MEP) monitoring |  | Baseline, 1, 3 , 6, 12 and 24 months post-treatment | 
| Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI) |  | Baseline, 1, 3 , 6, 12 and 24 months post-treatment | 
| Change in Walking Speed |  | Baseline, 1, 3 , 6, 12 and 24 months post-treatment | 
| Change in Stride length |  | Baseline, 1, 3 , 6, 12 and 24 months post-treatment |