The purpose of this study was to determine the safety and therapeutic effect of sub-retinal transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in patients with macular degeneration diseases, and explore new treatment modalities for macular degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Transplant hESC-RPE into subretinal space of patients with macular degeneration
Southwest Hospital
Chongqing, Chongqing Municipality, China
Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]
Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment
Time frame: up to 12 months
Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize
Visual acuity is reflected by number of ETDR letters participants can recognize
Time frame: up to 12 months
Visual Field as examined by Static perimetry
Area and sensitivity of visual field are detected by Static perimetry
Time frame: up to 12 months
Flash Electroretinogram (FERG)
Retinal electrophysiological function is tested by FERG
Time frame: up to 12 months
Amplitude and Latency of Flash Visual Evoked Potentials (FVEP)
Optic nerve function as assessed by FVEP
Time frame: up to 12 months
Multifocal Electroretinogram (MFERG)
Local retinal function as assessed by MFERG
Time frame: up to 12 months
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