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

Phase 1

• Conditions: Spinal Cord Injury
• Interventions: Biological: NeuroRegen scaffold/neural stem cells transplantation; Biological: NeuroRegen scaffold/mesenchymal stem cells transplantation

• Registration Number: NCT02688049
• Lead Sponsor: Chinese Academy of Sciences

Brief Summary

The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury.

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: 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
NeuroRegen scaffold/neural stem cells transplantation	NeuroRegen scaffold/neural stem cells transplantation	Patients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury.
NeuroRegen scaffold/mesenchymal stem cells transplantation	NeuroRegen scaffold/mesenchymal stem cells transplantation	Patients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Improvements in Independence Measures	1, 3, 6, 12, 18 and 24 months	Functional Independence Measure (FIM) will be assessed before and after surgery.
Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI)	1, 3, 6, 12, 18 and 24 months	The MRI at the transplantation site will be assessed before and after transplantation.
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.

Trial Locations

Locations (1)

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