A Study of transplantation of allogenic induced pluripotent stem cell (iPSC) derived retinal pigment epithelium (RPE) cell suspension in subjects with neovascular age related macular degeneratio
- Conditions
- eovascular age related macular degeneration
- Registration Number
- JPRN-UMIN000026003
- Lead Sponsor
- Kobe City Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Not provided
(1)-4) applicable only in subject eye) 1) Ocular infection 2) Other retinal disease (diabetic retinopathy, hypertensive retinopathy, vascular occlusion, etc.) 3) Optic nerve atrophy 4) Glaucoma with poorly controled intraocular pressure 5) Severe liver dysfunction (AST/ALT 100 IU/L or higher) 6) Severe renal impairment that require dialysis 7) Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency Virus, Adult T-cell Leukemia Virus, cases of Syphilis-positive 8) Allergic to bovine serum or antibiotics (penicillin, streptomycin) 9) Unable to quit anti-coagulants or anti-platelet medication 10) Malignant carcinoma (except for carcinoma in situ) or its history in the past 3 years 11) Allergic to fluorescein or indocyanine green angiography 12) Possible pregnancy or with the partner having a wish for pregnancy 13) Enrolled in another clinical study in the past 1 month 14) Judged unsuitable for study participation by the principal investigator or co-investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety of the investigational treatment: the presence or absence, severity and frequency of each of the following adverse events (AE) due to the iPS cell-derived RPE cell transplantation surgery. [Adverse events associated with the iPSC-derived RPE cells] 1. Graft failure, immune rejection 2. Excessive proliferation or tumorigenesis by the graft cells [Adverse events associated with the transplantation surgery or its procedure] 1. Retinal, choroidal or vitreous hemorrhage 2. Retinal detachment
- Secondary Outcome Measures
Name Time Method (1) Safety The severity and frequency of AEs other than those described above and are associated with iPSC derived RPE cells. The severity and frequency of AEs other than those described above and are associated with the transplantation surgery or its procedure. The severity, frequency, and type of all AEs (based on the CTCAE v4.0-JCOG) other than those described above. (2) Efficacy - Foveal retinal thickness, subretinal fluid, retinal edema by OCT. - Retinal sensitivity accessed by multi-local ERG and microperimetry . - Visual acuity. - The dye leakage of CNV by fluorescence angiography - The interval period until next treatment of anti-VEGF drugs because of the recurrence of CNV and the anti-VEGF drug treatment times during 1 year from the RPE cell transplantation. - Change in QOL.