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Note: This record shows only the 20 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.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00816803
Date of registration: 31/12/2008
Primary sponsor: Cairo University
Public title: Cell Transplant in Spinal Cord Injury Patients
Scientific title: Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
Date of first enrolment: May 2005
Target sample size: 80
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00816803
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Countries of recruitment
Egypt
Contacts
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Chronic Spinal Cord Injury
Intervention(s)
Procedure: Autologous bone marrow transplant
Procedure: Physical therapy
Primary Outcome(s)
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]
Secondary Outcome(s)
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]
Secondary ID(s)
EGY-SCI-1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Al-Azhar University
Alexandria University
Medical Military Academy, Egypt
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