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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: |
NCT01068561 |
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Date of registration:
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10/02/2010 |
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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 Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa
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Scientific title:
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Phase 1 Study Of Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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5 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01068561 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, 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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Brazil
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Contacts
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Name:
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Rubens C Siqueira, 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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Research Center Rubens Siqueira,Catanduva Medicine School and São Paulo University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- diagnosis of retinitis pigmentosa
- logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent,
20/200) or worse
Exclusion Criteria:
- previous ocular surgery other than cataract
- presence of cataract or other media opacity that would influence ocular fundus
documentation and adequate ERG and visual field evaluation
- other ophthalmic disease like glaucoma and uveitis
- previous history of blood disorders like leukemia
- known allergy to fluorescein or indocyanine green
- known coagulation abnormalities or current use of anticoagulative medication other
than aspirin.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Retinitis Pigmentosa
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Intervention(s)
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Biological: intravitreal injection of autologous bone marrow stem cells
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Primary Outcome(s)
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severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale
[Time Frame: 3-6 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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