Clinical Study of Transplanting Human Retinal Pigment Epithelial Cells for Treatment of Macular Degeneration

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 9
• Participant gender: All

Summary

This study is an open-label investigation of the safety and preliminary efficacy of the subretinal transplantation of human retinal pigment epithelial cells on Macular Degeneration.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai East Hospital
• Collaborator: Eyecure Therapeutics Inc.
• Last Updated: 2017-07-10

Criteria

Inclusion Criteria:

• Age 50~80 years;

• Diagnosed as atrophic macular degeneration (>250 microns of geographic atrophy involving central fovea);

• BCVA of study eye equal to or worse than 20/200, BCVA of control eye equal to or better than 20/200;

• Good health condition: Normal vital signs, electrocardiogram, routine blood and urine tests;

• Understand and be able to sign the informed consent.

Exclusion Criteria:

• Hemoglobin<10g/dL; platelet count<100k/mm^3;neutrophil count<1000/mm^3;

• ALT/AST>1.5; creatinine level>1.3mg/dL;

• Presence of glaucomatous optic neuropathy in the study eye;

• Progressive Cataract causing difficulty of retina examination;

• Any eye surgery other than cataract surgery within previous 3 months;

• History of retina detachment repair in the study eye;

• Uveitis or other intraocular inflammatory disease in the study eye;

• Any other sight-threatening ocular disease;

• Participation in any clinical trial of a drug by ocular or systemic administration within the past 6 months;

• History of malignancy (except excised basal cell or squamous cell of skin);

• History of myocardial infarction;

• History of diabetes mellitus;

• History of Parkinson's disease or Alzheimer's disease;

• Any current immunosuppressive therapy other than intermittent or low dose corticosteroids;

• Any other medical condition that affects patient compliance, patient safety, or the outcome of this clinical study.