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

hunheekang@chamc.co.kr

Public email

hunheekang@chamc.co.kr

First name

Hunhee

Last name

Kang

Country

South Korea

Cell Line

Stem cell lines obtained from

ACTe002-A

Recruitment

Recruitment Status

Unknown Status

Estimated number of participants