NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in SCI

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and complete spinal cord injury, compared to the treatment of surgical intradural decompression and adhesiolysis only.

Official Title
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NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in Patients With Chronic Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Biological: NeuroRegen Scaffold with BMMCs transplantation
* Procedure: Surgical intradural decompression and adhesiolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completely spinal cord injury at the thoracic level as assessed by magnetic resonance imaging (MRI) and electrophysiology. ASIA Impairment Scale (AIS) grade A. Male or female, 18-60 years old. No significant further improvement after injury and rehabilitation. Patients with normal peripheral nerve function and without muscle atrophy. Cardiovascular, respiratory, liver, kidney functions and laboratory examinations are within normal ranges. No brain disease or mental disorder. Ability and willingness to regular visit to hospital and follow up during the protocol procedures. Patients signed informed consent. Exclusion Criteria: A current diagnosis of any primary diseases affecting limb functions (e.g., traumatic brain injury, cerebral hemorrhage, cognitive disorders or other central nervous system diseases). Patients without any rehabilitation train after injury. Remarkable muscle atrophy or fibrosis. Degeneration of peripheral nerve function. Allergic constitution. Participation in any immunomodulator therapy or experimental drug treatment within 60 days prior to study. Suffering diabetes, autoimmune diseases, tumor or severe hypertension. Patients with severe heart, lung, liver or renal dysfunction are unable to meet the surgery standards. Severe bleeding tendency or abnormal coagulation function. Inflammation or skin ulcers at the surgical site. Lactating and pregnant woman. 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: 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroRegen Scaffold with BMMCs transplantation<br> | Biological: NeuroRegen Scaffold with BMMCs transplantation<br>* Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.<br>|
| Experimental: Surgical intradural decompression and adhesiolysis<br> | Procedure: Surgical intradural decompression and adhesiolysis<br>* Patients with chronic SCI (ASIA grade A) will receive intradural decompression and adhesiolysis surgery 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 | 
| Magnetic Resonance Imaging (MRI) | The change of treated spinal cord injury will be assessed by Magnetic Resonance Imaging (MRI) before and after surgery. | 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 |