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Trial record 17 of 28 for:    stem cell Spinal Cord Injury AND marrow

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352077
Recruitment Status : Enrolling by invitation
First Posted : February 2, 2015
Last Update Posted : January 7, 2019
Sponsor:
Collaborators:
Affiliated Hospital of Logistics University of CAPF
The First Affiliated Hospital of Soochow University
First Hospitals affiliated to the China PLA General Hospital
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

Tracking Information
First Submitted Date  ICMJE January 20, 2015
First Posted Date  ICMJE February 2, 2015
Last Update Posted Date January 7, 2019
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
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 with MSCs transplantation.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02352077 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed [ Time Frame: 12 months ]
    Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.
  • 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.
  • Improvements in Independence Measures and Quality of Life [ Time Frame: 12 months ]
    Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation.
  • Improvements in Pain assessed based on Visual analog scale (VAS) [ Time Frame: 12 months ]
    Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation.
  • Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation [ Time Frame: 12 months ]
    The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation.
  • Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI) [ Time Frame: 12 months ]
    The MRI at the transplantation site will be assessed before and after transplantation.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
  • 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.
  • Improvements in Independence Measures and Quality of Life [ Time Frame: 12 months ]
    Functional Independence Measure (FIM) and the Quality of Life Questionnaire (EQ 5D) will be assessed before and after transplantation.
  • Improvements in Pain assessed based on Visual analog scale (VAS) [ Time Frame: 12 months ]
    Pain intensity will be assessed based on Visual analog scale (VAS) before and after transplantation.
  • Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed [ Time Frame: 12 months ]
    Somatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.
  • Improvements in Muscle Contraction Force electromyography (EMG) score during contraction of given muscles [ Time Frame: 12 months ]
    The electromyography (EMG) score during contraction of given muscles will be assessed before and after transplantation.
  • Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation [ Time Frame: 12 months ]
    The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after transplantation.
  • Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI) [ Time Frame: 12 months ]
    The MRI at the transplantation site will be assessed before and after transplantation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair
Official Title  ICMJE Safety and Efficacy of NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells or Mesenchymal Stem Cells for Chronic Spinal Cord Injury Repair
Brief Summary The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Study Arms  ICMJE Experimental: NeuroRegen Scaffold with BMMCs or MSCs transplantation
Intervention: Biological: NeuroRegen scaffold with BMMCs or MSCs 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
Actual Enrollment  ICMJE
 (submitted: January 30, 2015)
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 NCT02352077
Other Study ID Numbers  ICMJE CAS-XDA-SCI/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
  • The First Affiliated Hospital of Soochow University
  • First Hospitals affiliated to the China PLA General Hospital
Investigators  ICMJE
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
PRS Account Chinese Academy of Sciences
Verification Date October 2016

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