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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02352077 |
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Date of registration:
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20/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair
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Scientific title:
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Safety and Efficacy of NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells or Mesenchymal Stem Cells for Chronic Spinal Cord Injury Repair |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02352077 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Shuxun Hou |
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Address:
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Telephone:
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Email:
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Affiliation:
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First Hospitals affiliated to the China PLA General Hospital |
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Name:
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Huilin Yang, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Affiliated Hospital of Soochow University |
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Name:
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Jianwu Dai, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chinese Academy of Sciences |
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Name:
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Sai Zhang, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Affiliated Hospital of Logistics Universtiy of CAPF |
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Key inclusion & exclusion criteria
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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 (?° 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spinal Cord Injury
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Intervention(s)
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Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation
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Primary Outcome(s)
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Safety Evaluation Number of patients with adverse events
[Time Frame: 6 months]
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Secondary Outcome(s)
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Improvements in Independence Measures and Quality of Life
[Time Frame: 12 months]
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Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed
[Time Frame: 12 months]
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Improvements in ASIA Impairment Scale
[Time Frame: 12 months]
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Improvements in Pain assessed based on Visual analog scale (VAS)
[Time Frame: 12 months]
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Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)
[Time Frame: 12 months]
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Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation
[Time Frame: 12 months]
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Secondary ID(s)
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CAS-XDA-SCI/IGDB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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