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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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22 April 2024 |
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Main ID: |
NCT01625559 |
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Date of registration:
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18/06/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy(SMD)
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Scientific title:
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A Phase I, Open-Label, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial(MA09-hRPE) Cells in Patients With Stargardt's Macular Dystrophy(SMD) |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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3 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01625559 |
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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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Korea, Republic of
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Contacts
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Name:
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Wonkyung Song |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHA Bundang Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult male or female over 20 years of age.
- Clinical diagnosis of advanced SMD.
- The visual acuity of the eye to receive the transplant will be no better than hand
movement.
- The visual acuity of the eye that is not to receive the transplant will be no better
than 24 (20/320) Early Treatment of Diabetic Retinopathy Study (ETDRS) letters.
Exclusion Criteria:
- History of malignancy.
- History of myocardial infarction in previous 12 months.
- History of diabetes mellitus.
- Any immunodeficiency.
- Any current immunosuppressive therapy other than intermittent or low dose cortico
steroids.
- Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
- Current participation in any other clinical trial.
- Participation within previous 6 months in any clinical trial of a drug by ocular or
systemic administration.
- Any other sight-threatening ocular disease.
- Any chronic ocular medications. Any history of retinal vascular disease (compromised
blood-retinal barrier). Glaucoma. Uveitis or other intraocular inflammatory disease.
Significant lens opacities or other media opacity. Ocular lens removal within previous
3 months
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stargardt's Macular Dystrophy
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Intervention(s)
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Biological: MA09-hRPE
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Primary Outcome(s)
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safety and tolerance of transplantation
[Time Frame: 18 months]
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Secondary Outcome(s)
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Evidence of successful engraftment
[Time Frame: 18 months]
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Secondary ID(s)
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CHA_CTP_0903
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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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