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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Transplantation of MA09-hRPE cells accoding to the assigned dose group
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Safety of hESC derived RPE cells
The transplantation of hESC-derived RPE cells MA09-hRPE will be considered safe in the absence of: 1. Any grade 2 (NCI grading system) or greater adverse event related to the cell product 2. Any evidence that the cells are contaminated with an infectious agent 3. Any evidence that the cells show tumorigenic potential
Time frame: 12 months
exploratory evaluations for potential efficacy endpoints
Secondary endpoints will be evaluated as exploratory evaluations for potential efficacy endpoints. * Change in the mean of BCVA * Autofluorescense photography * Reading speed Evidence of successful engraftment will consist of: * Structural evidence (OCT imaging, fluorescein angiography, slitlamp examination with fundus photography) that cells have been implanted in the correct location * Electroretinographic evidence (mfERG) showing enhanced activity in the implant location
Time frame: 12months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.