Treatment of Dry Age Related Macular Degeneration Disease With Retinal Pigment Epithelium Derived From Clinical-grade Human Embryonic Stem Cells

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 atrophic macular degeneration
Link http://www.ebi.ac.uk/efo/EFO_1001492
Description Dry AMD is most common type of macular degeneration and affects 90% of the people who have the condition. In the dry form, there is a breakdown or thinning of the layer of retinal pigment epithelial cells (RPE) in the macula. No medical or surgical treatment is available for this condition.

Administrative Information

NCT number NCT03046407
ICTRP weblink http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03046407
Other study identifiers
Name ChineseASZQ-004
Source weblink https://clinicaltrials.gov/show/NCT03046407
Regulatory body approval
Name National Health Commission of the PRC;National medical products administration
Country
China
Approval number CMR-20161213-1003
Study sites
Public contact
Email wangliu@ioz.ac.cn
Public email wangliu@ioz.ac.cn
First name Liu
Last name Wang
Country
China
Sponsors Chinese Academy of Sciences
Collaborators

Cell Line

Recruitment

Recruitment Status Recruiting
Estimated number of participants 10
Contact institutions/departments