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

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

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Biological: NeuroRegen Scaffold with BMMCs transplantation; Procedure: Surgical intradural decompression and adhesiolysis

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100101
    • First Affiliated Hospital of PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NeuroRegen Scaffold with BMMCs transplantation	Biological: NeuroRegen Scaffold with BMMCs transplantation; 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.
Experimental: Surgical intradural decompression and adhesiolysis	Procedure: Surgical intradural decompression and adhesiolysis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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
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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: First Hospitals affiliated to the China PLA General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 6, 2016
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: CAS-XDA-SDSCI/IGDB