A Phase I/IIa, Open-Label, Single-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 Age-related Macular Degeneration (AMD)

General Information

Summary

To evaluate the safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry AMD To evaluate the safety of the surgical procedures when used to implant MA09-hRPE cells To assess the number of hRPE cells to be transplanted in future studies To evaluate on an exploratory basis potential efficacy endpoints to be used in future studies of MA09-hRPE cellular therapy.

Clinical trials phase

Phases 1/2

Start date (estimated)

2012-09-01

End date (estimated)

2020-06-30

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].

Administrative Information

NCT number

NCT01674829

ICTRP weblink

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT01674829

Other study identifiers

Name	CHA CTP 1101

Source weblink

http://www.clinicaltrials.gov/ct2/show/NCT01674829

Regulatory body approval

Name

Korea Food and Drug Administration (KFDA)

Country

South Korea

Public contact

Email	songwkmd@daum.net

Cells

Source pluripotent stem cell lines

ACTe002-A

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

Active, not recruiting

Estimated number of participants