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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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8 January 2024 |
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Main ID: |
NCT01736059 |
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Date of registration:
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25/07/2012 |
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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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Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
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Scientific title:
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A Pilot Clinical Trial of the Feasibility and Safety of Intravitreal Autologous Adult Bone Marrow Stem Cells in Treating Eyes With Vision Loss From Retinopathy |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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15 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01736059 |
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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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United States
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Contacts
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Name:
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Susanna s Park, MD 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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University of California Davis Eye Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age >18 years of age
- visual acuity 20/100 to CF
- duration of vision loss > 3 months
- vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or
diabetic retinopathy
- the study eye has the worse visual acuity
- no active eye or systemic disease
- no history of macular edema or retinal/choroidal neovascularization requiring
treatment within 6 months
- no significant media opacity
- no coagulopathy or other hematologic abnormality
- no concurrent immunosuppressive therapy
- able to keep follow-up for 6 months
Exclusion Criteria:
- allergy to fluorescein dye
- other concurrent retinal or optic nerve disease affecting vision
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hereditary Macular Degeneration
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Retina Vein Occlusion
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Retinitis Pigmentosa
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Diabetic Retinopathy
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Non-exudative Age-related Macular Degeneration
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Intervention(s)
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Drug: CD34+ bone marrow stem cells intravitreal
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Primary Outcome(s)
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Incidence and severity of ocular adverse events
[Time Frame: 1 day to 6 months]
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Secondary Outcome(s)
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The number of stem cells isolated and injected into the study eye
[Time Frame: 1 day]
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Secondary ID(s)
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906595
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BMSCRetPilot
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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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