NCT01674829

A PhaseI/IIa Study to Determine the Safety and Tolerability of MA09-hRPE Cells in Patients With Advanced Dry AMD

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: CHABiotech CO., Ltd · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Age Related Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	MA09-hRPE	Transplantation of MA09-hRPE cells accoding to the assigned dose group

Timeline

• Start date: 2012-09-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2012-08-29
• Last updated: 2024-04-09

Locations

1 site across 1 country: South Korea