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) 2016-04-30
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 NCT01674829
ICTRP weblink http://apps.who.int/trialsearch/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 hunheekang@chamc.co.kr
Public email hunheekang@chamc.co.kr
First name Hunhee
Last name Kang
Country
South Korea
Sponsors CHABiotech CO., Ltd

Cell Line

Stem cell lines obtained from