Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation in Complete (AISA) Acute Spinal Cord Injury Patients

Chinese Academy of Sciences5 sites in 1 country20 target enrollmentApril 2015

ConditionsAcute Spinal Cord Injury

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Spinal Cord Injury
Sponsor: Chinese Academy of Sciences
Enrollment: 20
Locations: 5
Primary Endpoint: Safety Evaluation Number of patients with adverse events
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is designed to assess the safety and efficacy of functional neural regeneration collagen scaffold transplanted into acute spinal cord injury patients.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

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 (C4-T12).
•Classification ASIA A, occurring within past 21 days.
•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.