Treatment of Dry Age Related Macular Degeneration Disease With Retinal Pigment Epithelium Derived From Human Embryonic Stem Cells
NCT ID: NCT03046407
Last Updated: 2018-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2017-09-06
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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retinal pigment epithelium transplantation
transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
retinal pigment epithelium transplantation
Transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
Interventions
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retinal pigment epithelium transplantation
Transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
Eligibility Criteria
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Inclusion Criteria
* 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;
* No CNV;
* 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
* 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;
* Patients who are using anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days（The results of VerifyNow test show that AUC is greater than 470 and PRU is more than 208）;
* Abnormal blood coagulation function or other obvious abnormal laboratory test results;
* Malignant tumor and history of malignant tumor;
* Women who are pregnant，prepare to be pregnant during the trial, be lactating；men who prepare to have baby during the trial;
* Any immune deficiency;
* Glucocorticoids or immunosuppressive drugs have been used in the last 3 months;
* Antipsychotic drugs have been used in the last 3 months, such as antidepressants, antipsychotic drugs, and so on;
* With hypersensitivity to tacrolimus or other macrolides;
* The history of addiction to alcoholism or prohibited drugs;
* Being participating in any intervention clinical trials;
* Poor compliance, difficult to complete the study;
* The person who did not receive the informed consent;
* Some researchers believe that there may be situations that can increase risks of the subjects or interfere clinical trials (for example, patients are prone to mental stress, depression, mental disorders, cognitive dysfunction, etc.).
55 Years
80 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Zhengzhou University
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Qi Zhou
Deputy director of Institute of zoology, chinese academy of sciences, and vice president of medical school， University of chinese academy of sciences
Principal Investigators
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Zhou Qi, Doctor
Role: PRINCIPAL_INVESTIGATOR
Institute of Zoology, Chinese Academy of Sciences
Locations
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The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Wan guang ming, Doctor
Role: primary
Li fu zhen, Doctor
Role: backup
Other Identifiers
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ChineseASZQ-004
Identifier Type: -
Identifier Source: org_study_id