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

Chinese Academy of Sciences

Status and phase: Unknown; Phase 1

Conditions: Acute Spinal Cord Injury

Treatments: Biological: Functional collagen scaffold

Study type: Interventional

Funder types: Other

Identifiers

NCT02510365

CAS-XDA-ACSCI/IGDB

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Functional collagen scaffold

Experimental group

Description:

Functional neural regeneration collagen scaffold transplantation.

Treatment:

Biological: Functional collagen scaffold