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
Link http://purl.obolibrary.org/obo/NCIT_C85078
Description An autosomal recessive and rarely autosomal dominant inherited disorder caused by mutations in the ABCA4 or ELOVL4 genes respectively. It is characterized by macular degeneration that begins in late childhood resulting in progressive loss of vision.

Administrative Information

NCT number NCT01625559
ICTRP weblink http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT01625559
Other study identifiers
Name CHA_CTP_0903
Source weblink https://clinicaltrials.gov/ct2/show/record/NCT01625559
Regulatory body approval
Name Korea Food and Drug Administration (KFDA)
Country
South Korea
Public contact
Email info@chabio.com
First name Wonkyung
Last name Song
Country
South Korea
Address freetext CHA Bundang Medical Center
Sponsors CHABiotech CO., Ltd

Cell Line

Stem cell lines obtained from

Recruitment

Recruitment Status Unknown Status
Estimated number of participants 3