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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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19 February 2015 |
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Main ID: |
NCT00816803 |
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Date of registration:
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31/12/2008 |
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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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Cell Transplant in Spinal Cord Injury Patients
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Scientific title:
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Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00816803 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Egypt
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Traumatic spinal cord injury
- No concomitant systemic disease
- No progress on physiotherapy for at least 6 months
- Duration of injury from 10 months to 3 years
Exclusion Criteria:
- Non-traumatic spinal cord injury whether transverse myelitis or demyelination
- Concomitant systemic disease
- Progress can be observed on physiotherapy
- Acute injury or duration of injury less than 10 months
Age minimum:
10 Years
Age maximum:
36 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Spinal Cord Injury
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Intervention(s)
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Procedure: Autologous bone marrow transplant
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Procedure: Physical therapy
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Primary Outcome(s)
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Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI.
[Time Frame: 18 months]
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Secondary Outcome(s)
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Efficacy of BM cell transplant in improving neurological functions in patients with chronic SCI. Improvement in motor, sensory and sphincteric functions, and quality of life using ASIA scores and MRI.
[Time Frame: 18 months]
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Secondary ID(s)
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EGY-SCI-1
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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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