NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair

Phase 1

• Conditions: Spinal Cord Injury
• Interventions: Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation

• Registration Number: NCT02352077
• Lead Sponsor: Chinese Academy of Sciences

Brief Summary

The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-02
• Status Verified: 2016-10
• 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: 30

Inclusion Criteria

1. Male or female, 18-65 years old.
2. Completely spinal cord injury at the cervical and thoracic level (C5-T12).
3. Classification ASIA A with no significant further improvement.
4. Patients signed informed consent.
5. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria

1. 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).
2. Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
3. History of life threatening allergic or immune-mediated reaction.
4. Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
5. History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
6. 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.
7. Lactating and pregnant woman.
8. Alcohol drug abuse /dependence.
9. Participated in any other clinical trials within 3 months before the enrollment.
10. A drug or treatment known to cause effect on the central nervous system during the past four weeks.
11. A drug or treatment known to cause major organ system toxicity during the past four weeks.
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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeuroRegen Scaffold with BMMCs or MSCs transplantation	NeuroRegen scaffold with BMMCs or MSCs transplantation	-

Primary Outcome Measures

Name	Time	Method
Safety Evaluation Number of patients with adverse events	6 months	Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold with MSCs transplantation.

Secondary Outcome Measures

Name	Time	Method
Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)	12 months	The MRI at the transplantation site will be assessed before and after transplantation.
Improvements in Independence Measures and Quality of Life	12 months	Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation.
Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation	12 months	The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation.
Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed	12 months	Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.
Improvements in ASIA Impairment Scale	12 months	American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation.
Improvements in Pain assessed based on Visual analog scale (VAS)	12 months	Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation.

Trial Locations

Locations (3)

First Hospitals affiliated to the China PLA General Hospital; 🇨🇳 Beijing, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, China

Affiliated Hospital of Logistics Universtiy of CAPF; 🇨🇳 Tianjin, China