The purpose of this study is to evaluate the safety and tolerability of RPE cellular therapy in patients with SMD
* to evaluate the safety and tolerability of RPE cellular therapy in patients with SMD * to evaluate the preliminary efficacy of MA09-hPRE in patients with SMD
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
MA09-hRPE cells
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
safety and tolerance of transplantation
The transplantation of hESC-derived RPE cells MA09-hRPE will be considered safe and tolerated 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: 18 months
Evidence of successful engraftment
Evidence of successful engraftmentEvidence of successful engraftment will consist of: Structural evidence (OCT imaging, fluorescein angiography, autofluorescense photography, slit-lamp 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: 18 months
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