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NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair

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ClinicalTrials.gov Identifier: NCT02688049
Recruitment Status : Enrolling by invitation
First Posted : February 23, 2016
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Affiliated Hospital of Logistics University of CAPF
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

Tracking Information
First Submitted Date  ICMJE February 6, 2016
First Posted Date  ICMJE February 23, 2016
Last Update Posted Date January 8, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
  • Improvements in ASIA (American Spinal Injury Association) Impairment Scale [ Time Frame: 24 months ]
  • Improvements in Somatosensory Evoked Potentials (SSEP) [ Time Frame: 24 months ]
  • Improvements in Motor Evoked Potentials (MEP) [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02688049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
  • Improvements in Independence Measures [ Time Frame: 1, 3, 6, 12, 18 and 24 months ]
    Functional Independence Measure (FIM) will be assessed before and after surgery.
  • Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI) [ Time Frame: 1, 3, 6, 12, 18 and 24 months ]
    The MRI at the transplantation site will be assessed before and after transplantation.
  • Improvements in Urinary and Bowel Function [ Time Frame: 1, 3, 6, 12, 18 and 24 months ]
    The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after surgery.
  • Safety and Tolerability assessed by Adverse Events [ Time Frame: Up to 6 months ]
    Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair
Official Title  ICMJE The Efficacy and Safety of NeuroRegen Scaffold™ Combined With Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair
Brief Summary The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE
  • Biological: NeuroRegen scaffold/mesenchymal stem cells transplantation
    Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million mesenchymal stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
  • Biological: NeuroRegen scaffold/neural stem cells transplantation
    Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million neural stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Study Arms  ICMJE
  • Experimental: NeuroRegen scaffold/mesenchymal stem cells transplantation
    Patients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury.
    Intervention: Biological: NeuroRegen scaffold/mesenchymal stem cells transplantation
  • Experimental: NeuroRegen scaffold/neural stem cells transplantation
    Patients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury.
    Intervention: Biological: NeuroRegen scaffold/neural stem cells transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: February 17, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 with no significant further improvement.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02688049
Other Study ID Numbers  ICMJE CAS-XDA-MNSCI/IGDB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jianwu Dai, Chinese Academy of Sciences
Study Sponsor  ICMJE Chinese Academy of Sciences
Collaborators  ICMJE Affiliated Hospital of Logistics University of CAPF
Investigators  ICMJE
Principal Investigator: Jianwu Dai, Ph.D Chinese Academy of Sciences
PRS Account Chinese Academy of Sciences
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP