Functional Neural Regeneration Collagen Scaffold Transplantation in Acute Spinal Cord Injury Patients

Phase 1

• Conditions: Acute Spinal Cord Injury
• Interventions: Biological: Functional collagen scaffold

• Registration Number: NCT02510365
• Lead Sponsor: Chinese Academy of Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Status Verified: 2015-07
• Study First Submitted: 2015-07-26
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-29
• 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: 20

Inclusion Criteria

1. Male or female, 18-65 years old.
2. Completely spinal cord injury at the cervical and thoracic level (C4-T12).
3. Classification ASIA A, occurring within past 21 days.
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
Functional collagen scaffold	Functional collagen scaffold	Functional neural regeneration collagen scaffold 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 transplantation.

Secondary Outcome Measures

Name	Time	Method
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 Electrophysiological monitoring	12 months	Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.

Trial Locations

Locations (5)

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

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

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, China

Xinqiao Hospital of Army Medical University; 🇨🇳 Chongqing, China

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