Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy (SMD)

General Information

Summary The purpose of this study is: To evaluate the safety and tolerability of RPE cellular therapy in patients with SMD Group. When-MA09-hRPE cell transplantation to evaluate the safety of surgical procedures. In future studies intended to assess the number of transplanted hRPE cells. In the past, MA09-hRPE cell therapy used in the study was to evaluate the validity of the potential. Homologous retinal pigment epithelial cells derived from embryonic stem cells, future studies of drugs that are used in representing the potential validity to evaluate the optimal dose.
Description Not Provided
Clinical trials phase Phase 1
Start date (estimated) 2012-09-01
End date (estimated) 2015-06-30
Clinical feature
Label Stargardt disease
Description An age related macular degeneration that is characterized by progressive vision loss usually to the point of legal blindness.

Administrative Information

NCT number NCT01625559
ICTRP weblink
Other study identifiers
Name CHA_CTP_0903
Source weblink
Regulatory body approval
Name Korea Food and Drug Administration (KFDA)
South Korea
Public contact
First name Wonkyung
Last name Song
South Korea
Address freetext CHA Bundang Medical Center
Sponsors CHABiotech CO., Ltd


Source pluripotent stem cell lines
Which differentiated cell type is used
Label retinal pigment epithelial cell
Description An epithelial cell of the retinal pigmented epithelium.


Recruitment Status Unknown Status
Estimated number of participants 3