Clinical study of repair materials for spinal cord injury

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-16008974

Enrollment

Unknown

Registered

2016-08-04

Start date

2016-10-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal cord injury

Interventions

Experimental Group:Nerve regeneration collagen scaffold transplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Complete spinal cord injury from C5-T11, ASIA A, electrophysiological examination and imaging examination confirmed, neurologic examination to determine the damage plane; 2. No limitations for both gender and age 18 to 50 years old; 3. To carry out rehabilitation training after spinal cord injury, and no obvious improvement; 4. Muscles is in good condition and peripheral nerve is normal; 5. Generally patients are in good condition, cardiovascular, respiratory, liver, kidney and other main system function is normal;Routine laboratory tests main index is normal; 6. No brain disease or psychological disorders; 7. Patient compliance is good; 8. Consent forms are signed.

Exclusion criteria

Exclusion criteria: 1. Patients with diseases affecting recovery of spinal cord injury or rehabilitation training; 2. Spianl cord injury beyond C5-T12; 3. Rehabilitation training was not performed after injury; 4. Muscles fibrosis or atrophy; 5. The function of peripheral nerve is degenerative; 6. Specific allergic constitution; 7. Patients received immune regulator treatment or experimental drug treatment in 60 days; 8. Patients with severe basic diseases, such as diabetes, autoimmune diseases, cancer or severe high blood pressure, etc; 9. Patients with poor general condition, cardiovascular, respiratory, liver and kidney dysfunction or other major system and can not tolerate surgery; 10. Patients with a tendency to severe bleeding or clotting dysfunction; 11. Surgical site has inflammation or skin ulcer; 12. Female patients pregnant or lactating; 13. Patients refused to sign informed consent; 14. Other conditions researchers think is not suitable for selected conditions.

Design outcomes

Primary

Measure	Time frame
ASIA score;Functional Independence Measure;Nerve Electrophysiology;MRI;Urodynamics;	—

Countries

China

Contacts

Public ContactHou Shuxun

The First Affiliated Hospital of the General Hospital of PLA

tangjiaguang2013@163.com+86 13801397974

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026