Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa

Qi Zhou1 site in 1 country10 target enrollmentMay 2020

Overview

Brief Summary

This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. 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 0f RPE transplants to treat RP disease.

Detailed Description

This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. 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 0f RPE transplants to treat RP disease.

Registry

clinicaltrials.gov

Start Date

May 2020

End Date

December 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Qi Zhou

Responsible Party

Sponsor Investigator

Principal Investigator

Qi Zhou

Director of Institute of zoology, chinese academy of sciences, and vice president of medical school， University of chinese academy of sciences

Chinese Academy of Sciences

Eligibility Criteria

Inclusion Criteria

•Age above 18 and under 80 years of age, both gender, in good health.
•Clinical diagnosis of retinitis pigmentosa, the results of eye electrophysiological examination accord with retinitis pigmentosa.
•The BCVA of target eye will not be better than 20/
•The BCVA of contralateral eye is not worse than 20/
•Diopter is smaller than 8.00 D, axial 28 mm or less.
•Voluntary as test subjects, signed informed consent, regular follow-up will be effected according to the specified time.

Exclusion Criteria

•Subject with other additional retinal diseases, like diabetic or hypertensive retinopathy vascular diseases.
•Target eye ever have had a eye surgery;
•Subject with active serious diseases of the digestive system, liver kidney impairment (ALT/AST) \> 1.5 or any known liver disease, creatine \> 1.3 mg/dL) and/serious temic diseases, such as cardiovascular tem, respiratory tem, nervous tem, endocrine tem urogenital tem diseases, etc.), the history of malignancy;
•Have been ready for pregnancy during test, are lactating women;
•Ready to birth of men during the test;
•Subject with any immunodeficiency;
•Subject in the immunosuppressive therapy in the current;
•Subject with the tacrolimus or other large ring lactone class drug allergies;
•Participate in any clinical subjects in nearly six months;
•Has a history of alcohol or illicit drug abuse;

Outcomes

Primary Outcomes

Adverse events and serious adverse events occurred within 1 year after transplantation

Time Frame: one year

The occurrence of adverse events (AE), severe adverse events (SAE), treatment-related adverse events (TEAE), and clinically significant vital signs during the study period.