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

Phase 1

• Conditions: Spinal Cord Injury
• Interventions: Biological: NeuroRegen Scaffold with BMMCs transplantation; Procedure: Surgical intradural decompression and adhesiolysis

• Registration Number: NCT02688062
• Lead Sponsor: Chinese Academy of Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-06
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-23
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Completely spinal cord injury at the thoracic level as assessed by magnetic resonance imaging (MRI) and electrophysiology.
2. ASIA Impairment Scale (AIS) grade A.
3. Male or female, 18-60 years old.
4. No significant further improvement after injury and rehabilitation.
5. Patients with normal peripheral nerve function and without muscle atrophy.
6. Cardiovascular, respiratory, liver, kidney functions and laboratory examinations are within normal ranges.
7. No brain disease or mental disorder.
8. Ability and willingness to regular visit to hospital and follow up during the protocol procedures.
9. Patients signed informed consent.

Exclusion Criteria

1. 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).
2. Patients without any rehabilitation train after injury.
3. Remarkable muscle atrophy or fibrosis.
4. Degeneration of peripheral nerve function.
5. Allergic constitution.
6. Participation in any immunomodulator therapy or experimental drug treatment within 60 days prior to study.
7. Suffering diabetes, autoimmune diseases, tumor or severe hypertension.
8. Patients with severe heart, lung, liver or renal dysfunction are unable to meet the surgery standards.
9. Severe bleeding tendency or abnormal coagulation function.
10. Inflammation or skin ulcers at the surgical site.
11. Lactating and pregnant woman.
12. Poor compliance, difficult to complete the study.
13. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NeuroRegen Scaffold with BMMCs transplantation	NeuroRegen Scaffold with BMMCs transplantation	-
Surgical intradural decompression and adhesiolysis	Surgical intradural decompression and adhesiolysis	-

Primary Outcome Measures

Name	Time	Method
Improvements in Somatosensory Evoked Potentials (SSEP)	24 months
Improvements in ASIA (American Spinal Injury Association) Impairment Scale	24 months
Improvements in Motor Evoked Potentials (MEP)	24 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Affiliated Hospital of PLA General Hospital; 🇨🇳 Beijing, China