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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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11 July 2016 |
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Main ID: |
NCT02482194 |
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Date of registration:
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18/06/2015 |
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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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Autologous Mesenchymal Stem Cells Transplantation for Spinal Cord Injury- A Phase I Clinical Study
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Scientific title:
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Autologous Transplantation of Bone Marrow Mesenchymal Stem Cells in Patients of Spinal Cord Injury-Phase I Clinical Trial |
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Date of first enrolment:
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June 2013 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02482194 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Parvez Ahmed |
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Address:
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Telephone:
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Email:
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Affiliation:
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Commandant Armed Forces Bone Marrow Transplant Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients suffering from sub-acute and chronic phase of spinal cord injury
- Traumatic spinal cord injury at the thoracic level
- American Spinal Injury Association (ASIA) impairment scale "A"
- Confirmation by MRI of injury level
- Time between injury and enrollment greater than 2 weeks
- Ability to provide informed consent
Exclusion Criteria:
- Axonic brain injury
- Inability to provide consent
- Open injuries
- Active infectious diseases
- Terminal patients
- Neurodegenerative diseases
- Evidence of meningitis
- Cerebral palsy
- Primary haematologic diseases
- Coagulopathies
- Pregnancy
- Other medical complications that contra-indicate surgery, including major respiratory
complications
- Use of metal implants close to vascular structures (such as cardiac pacemaker or
prosthesis) that contraindicate MRI.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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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: mesenchymal stem cells
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Primary Outcome(s)
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Number of adverse events
[Time Frame: 1 month]
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Secondary Outcome(s)
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Functional Independence
[Time Frame: 1 year]
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Sensory and motor strength
[Time Frame: 1 year]
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Muscle strength assessment
[Time Frame: 1 year]
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Secondary ID(s)
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AFBMTC-SCI-2013
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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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