General Information |
| Summary |
This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space of patients to treat dry age-related macular degeneration(dry-AMD). And we will assess the safety and efficacy of RPE transplants to treat dry AMD. |
| Description |
This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space of patients to treat dry age-related macular degeneration(dry-AMD). Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the safety and efficacy of RPE transplants to treat dry AMD. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2017-09-06 |
| End date (estimated) |
2020-12-31 |
| Clinical feature |
| Label |
age related macular degeneration |
| Link |
http://purl.obolibrary.org/obo/DOID_10871 |
| Description |
A degeneration of macula and posterior pole that is characterized by a loss of vision in the center of the visual field (the macula) resulting from damage to the retina and resulting in blurring of the sharp central vision.; OMIM mapping confirmed by DO. [SN]. |
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Administrative Information |
| NCT number |
NCT03046407 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03046407 |
| Other study identifiers |
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| Source weblink |
https://clinicaltrials.gov/show/NCT03046407 |
| Regulatory body approval |
| Name |
National Health Commission of the PRC;National medical products administration |
| Country |
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| Approval number |
CMR-20161213-1003 |
| Study sites |
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| Public contact |
| Email |
wangliu@ioz.ac.cn |
| Public email |
wangliu@ioz.ac.cn |
| First name |
Liu |
| Last name |
Wang |
| Country |
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| Sponsors |
Chinese Academy of Sciences
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| Collaborators |
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Cells |
| Which differentiated cell type is used |
| Label |
retinal pigment epithelial cell |
| Link |
http://purl.obolibrary.org/obo/CL_0002586 |
| Description |
An epithelial cell of the retinal pigmented epithelium. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
10 |
| Contact institutions/departments |
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