The Efficacy and Safety of NeuroRegen Scaffold™ Combined With Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair

Chinese Academy of Sciences1 site in 1 country30 target enrollmentJanuary 2016

ConditionsSpinal Cord Injury

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Spinal Cord Injury
Sponsor: Chinese Academy of Sciences
Enrollment: 30
Locations: 1
Primary Endpoint: Improvements in ASIA (American Spinal Injury Association) Impairment Scale
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chinese Academy of Sciences

Responsible Party

Principal Investigator

Jianwu Dai

Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Chinese Academy of Sciences

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Improvements in ASIA (American Spinal Injury Association) Impairment Scale

Time Frame: 24 months

Improvements in Somatosensory Evoked Potentials (SSEP)

Time Frame: 24 months

Improvements in Motor Evoked Potentials (MEP)

Time Frame: 24 months

Secondary Outcomes

Improvements in Urinary and Bowel Function(1, 3, 6, 12, 18 and 24 months)
Improvements in Independence Measures(1, 3, 6, 12, 18 and 24 months)
Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI)(1, 3, 6, 12, 18 and 24 months)
Safety and Tolerability assessed by Adverse Events(Up to 6 months)