Safety and Efficacy of Subretinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Age-related Macular Degeneration Diseases
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dry Age-related Macular Degeneration
- Sponsor
- Chinese Academy of Sciences
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- safety and tolerance of transplantation
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Qi Zhou
The vice President and deputy director of Institute of zoology, chinese academy of sciences
Chinese Academy of Sciences
Eligibility Criteria
Inclusion Criteria
- •Aged 55-80 years;
- •Clinical diagnosis is consistent with the definition of late dry AMD in the age-related eye disease study (AREDS) (with one or more \>250 micron geographic atrophy in the fovea;
- •The BCVA of target eye will not be better than 20/200;
- •-8.00D\<diopter\<+8.00D，21mm\<axis oculi≤28mm;
- •voluntary as test subjects, signed informed consent, regular follow-up on time.
Exclusion Criteria
- •The macular atrophy caused by other diseases in addition to AMD;
- •Suffer from retinitis pigmentosa, choroidal retinitis, central serous chorositis, diabetic retinopathy or other retinal vascular and degenerative diseases besides AMD;
- •Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy and other ocular history;
- •Other intraocular surgery history besides cataract surgery;
- •In the last 6 months, there were severe heart failure (New York Heart Association grade III and IV) or the left ventricular ejection fraction \<35% in any examinations
- •One of the following circumstances: (1) dialysis or eGFR\<20ml/min/1.73m2; (2) urinary protein / urinary creatinine is ≥1g/g; (3) creatinine or albumin / urinary creatinine is ≥600mg/g;
- •Chronic liver disease, ALT increased \>3 times normal value of the upper limit;
- •Combined with other serious systemic diseases, such as cor pulmonale, severe COPD (FEV1%\<50%) and so on;
- •Combined with severe infectious diseases (such as HIV, syphilis antibody positive, etc;
- •The quantitative detection of HCV-RNA was positive, the quantitative detection of HBV-DNA was greater than 103 IU/ml, and tuberculosis was in the contagious period, etc;
Outcomes
Primary Outcomes
safety and tolerance of transplantation
Time Frame: one year
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.
Secondary Outcomes
- Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs)(one year)
- Efficacy：Best corrected visual acuity（BCVA）(one year)
- Efficacy：Optical coherent tomography (OCT)(one year)
- Efficacy：fundus autofluorescence(one year)