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

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ClinicalTrials.gov Identifier: NCT02352077
Recruitment Status : Enrolling by invitation
First Posted : February 2, 2015
Last Update Posted : January 3, 2018
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

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells or Mesenchymal Stem Cells for Chronic Spinal Cord Injury Repair
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NeuroRegen Scaffold with BMMCs or MSCs transplantation 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.




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 with MSCs transplantation.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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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 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.

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): NCT02352077


Locations
China
First Hospitals affiliated to the China PLA General Hospital
Beijing, China, 100037
The First Affiliated Hospital of Soochow University
Soochow, China, 215006
Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, China, 300162
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
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

Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02352077     History of Changes
Other Study ID Numbers: CAS-XDA-SCI/IGDB
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: October 2016

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