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

Acute Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02510365
• Other study ID #: CAS-XDA-ACSCI/IGDB
• Status: Recruiting
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: December 2021

Study information

• Verified date: July 2015
• Source: Chinese Academy of Sciences
• Contact: Zhifeng Xiao, Ph.D
• Phone: 86-10-82614420
• Email: zfxiao[@]genetics.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 (?° 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.

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Biological:
• Functional collagen scaffold
Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery.

Locations

Country	Name	City	State
China	First Hospitals affiliated to the China PLA General Hospital	Beijing
China	Xinqiao Hospital of Army Medical University	Chongqing
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Affiliated Hospital of Logistics Universtiy of CAPF	Tianjin
China	General Hospital of Ningxia Medical University	Yinchuan

Sponsors (6)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Affiliated Hospital of Logistics University of CAPF, First Hospitals affiliated to the China PLA General Hospital, General Hospital of Ningxia Medical University, The First Affiliated Hospital of Soochow University, Xinqiao hospital of Army Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Evaluation Number of patients with adverse events	Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold transplantation.	6 months
Secondary	Improvements in ASIA Impairment Scale	American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation.	12 months
Secondary	Improvements in Electrophysiological monitoring	Somatosensory Evoked Potentials (SSEP) monitoring will be assessed before and after transplantation.	12 months
Secondary	Improvements in Electrophysiological monitoring	Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.	12 months