This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space of patients to treat dry age-related macular degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants to treat dry AMD.
This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space to treat age-related macular degeneration(AMD). Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety of RPE transplants to treat AMD disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
Beijing Tongren Hospitol,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGsafety and tolerance of transplantation
The safety and tolerance of transplantation of clinical grade hESC-derived RPE will be considered safe: no above moderate adverse events or severe adverse events which related to transplantation of retinal pigment epithelial cells ; Cells without infectious; No tumorigenicity. Through the clinical signs of subjects and laboratory examination to judge the tolerance, integrity, repellency of RPE cells, and monitoring the presence of local or systemic infection, and presence of metastatic tumor cells.
Time frame: one year
Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs)
Visual function measure: change in visual acuity
Time frame: one year
Efficacy:Best corrected visual acuity(BCVA)
Visual function measure: change in visual acuity
Time frame: one year
Efficacy:Optical coherent tomography (OCT)
Transplant and host retina integrity and survival
Time frame: one year
Efficacy:fundus autofluorescence
Transplant and host retina integrity and survival
Time frame: one year
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