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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 November 2024 |
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Main ID: |
NCT02463344 |
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Date of registration:
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13/05/2015 |
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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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Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD
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Scientific title:
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Long Term Follow up to A Phase I/II, Open-Label, Multi-Center, 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 Advanced Dry AMD |
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Date of first enrolment:
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February 25, 2013 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02463344 |
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Study type:
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Observational |
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Study design:
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Phase:
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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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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Institute for Regenerative Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Must have been treated with hESC-RPE cell transplant in the core protocol.
- Able to understand and willing to sign the informed consent to participate in the
follow up study.
Exclusion Criteria:
- There are no exclusion criteria.
Age minimum:
55 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Age-Related Macular Degeneration
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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 assessed by Adverse Events (AEs) of special interest in regards to the investigational product
[Time Frame: 4 years]
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Secondary Outcome(s)
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Incidence of graft failure or rejection
[Time Frame: 4 years]
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Number of patients with changes in ocular examinations or images
[Time Frame: 4 years]
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Secondary ID(s)
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ACT MA09-hRPE AMD -001 LTFU
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7316-CL-0005
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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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