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Trial record 1 of 1 for:    NCT02510365
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Functional Neural Regeneration Collagen Scaffold Transplantation in Acute Spinal Cord Injury Patients

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ClinicalTrials.gov Identifier: NCT02510365
Recruitment Status : Recruiting
First Posted : July 29, 2015
Last Update Posted : January 3, 2018
Sponsor:
Collaborators:
Affiliated Hospital of Logistics University of CAPF
The First Affiliated Hospital of Soochow University
Information provided by (Responsible Party):
Jianwu Dai, 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.

Condition or disease Intervention/treatment Phase
Acute Spinal Cord Injury Biological: Functional collagen scaffold Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation in Complete (AISA) Acute Spinal Cord Injury Patients
Study Start Date : April 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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.




Primary Outcome Measures :
  1. Safety Evaluation Number of patients with adverse events [ Time Frame: 6 months ]
    Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold transplantation.


Secondary Outcome Measures :
  1. Improvements in ASIA Impairment Scale [ Time Frame: 12 months ]
    American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation.

  2. Improvements in Electrophysiological monitoring [ Time Frame: 12 months ]
    Somatosensory Evoked Potentials (SSEP) monitoring will be assessed before and after transplantation.

  3. Improvements in Electrophysiological monitoring [ Time Frame: 12 months ]
    Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18-65 years old.
  2. Completely spinal cord injury at the cervical and thoracic level (C5-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510365


Contacts
Contact: Zhifeng Xiao, Ph.D 86-10-82614420 zfxiao@genetics.ac.cn
Contact: Sufang Han, Ph.D 86-10-82614420 sufanghan22@genetics.ac.cn

Locations
China
The First Affiliated Hospital of Soochow University Recruiting
Soochow, China, 215006
Contact: Huilin Yang, Ph.D         
Contact: Qin Shi, Ph.D    86-512-67781169    qshisz@gmail.com   
Affiliated Hospital of Logistics Universtiy of CAPF Recruiting
Tianjin, China, 300162
Contact: Sai Zhang, M.D    86-22-60577101      
Contact: Shixiang Cheng    86-22-60577171    shixiangcheng@vip.126.com   
Sponsors and Collaborators
Chinese Academy of Sciences
Affiliated Hospital of Logistics University of CAPF
The First Affiliated Hospital of Soochow 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

Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02510365     History of Changes
Other Study ID Numbers: CAS-XDA-ACSCI/IGDB
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: July 2015

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System