Functional Neural Regeneration Collagen Scaffold Transplantation in Acute Spinal Cord Injury Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Functional collagen scaffold Functional neural regeneration collagen scaffold transplantation. |
Biological: Functional collagen scaffold
Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Somatosensory Evoked Potentials (SSEP) monitoring 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.
Eligibility Criteria
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.
-
A drug or treatment known to cause major organ system toxicity during the past four weeks.
-
Poor compliance, difficult to complete the study.
-
Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Hospitals affiliated to the China PLA General Hospital | Beijing | China | 100037 | |
| 2 | Xinqiao Hospital of Army Medical University | Chongqing | China | 400037 | |
| 3 | The First Affiliated Hospital of Soochow University | Suzhou | China | 215006 | |
| 4 | Affiliated Hospital of Logistics Universtiy of CAPF | Tianjin | China | 300162 | |
| 5 | General Hospital of Ningxia Medical University | Yinchuan | China | 750004 |
Sponsors and Collaborators
- Chinese Academy of Sciences
- Affiliated Hospital of Logistics University of CAPF
- The First Affiliated Hospital of Soochow University
- First Hospitals affiliated to the China PLA General Hospital
- General Hospital of Ningxia Medical University
- Xinqiao hospital of Army Medical University
Investigators
- Principal Investigator: Jianwu Dai, Ph.D, Chinese Academy of Sciences
- Study Chair: Sai Zhang, M.D, Affiliated Hospital of Logistics Universtiy of CAPF
- Study Chair: Huilin Yang, Ph.D, The First Affiliated Hospital of Soochow University
- Study Chair: Shuxun Hou, First Hospitals affiliated to the China PLA General Hospital
- Study Chair: Hechun Xia, General Hospital of Ningxia Medical University
- Study Chair: Tongwei Chu, Xinqiao hospital of Army Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAS-XDA-ACSCI/IGDB