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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: |
NCT02638714 |
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Date of registration:
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07/12/2015 |
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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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Treatment of Optic Neuropathies Using Autologous Bone Marrow-Derived Stem Cells
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Scientific title:
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Treatment of Optic Neuropathies Using Autologous Bone-Marrow Derived Clusters of Differentiation (CD) 34+, 133+, and 271+ Stem Cells: A Pilot Study |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02638714 |
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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/Phase 2
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Countries of recruitment
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Jordan
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Contacts
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Name:
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Adeeb AlZoubi, PhD |
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Address:
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Telephone:
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Email:
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adeebalzoubi@stemcellsarabia.net |
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Affiliation:
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Name:
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Adeeb AlZoubi, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient should suffer from Optic Nerve Atrophy diseases like diabetic retinopathy and
retinal pigmentation.
- Age in between 18-55 years old
- Willingness to undergo bone marrow derived autologous cell therapy.
- Ability to comprehend the explained protocol
- Ability and willingness to regularly visit to hospital for protocol and follow up
Exclusion Criteria:
- Patients with preexisting or current systemic disease such as lung, liver,
gastrointestinal, cardiac, immunodeficiency, syphilis, or clinically relevant
polyneuropathies.
- History of life threatening allergic or immune- mediated reaction
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Optic Neuropathy
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Intervention(s)
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Biological: Stem Cells
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Primary Outcome(s)
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Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters
[Time Frame: 24 months]
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Secondary Outcome(s)
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improvement in visual function using the documentation of visual acuity using the Snellen chart
[Time Frame: 24 months]
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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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