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

Korábbi kezelés

• Target eye ever have had a eye surgery;
• Subject in the immunosuppressive therapy in the current;

Más betegség

• Subject with other additional retinal diseases, like diabetic or hypertensive retinopathy vascular diseases.
• Subject with the tacrolimus or other large ring lactone class drug allergies;
• Has a history of alcohol or illicit drug abuse;
• Researchers believe that there may be an increased risk subjects or interfere with the clinical trials of any situation (such as when a patient is prone to mental tension, depression, mental illness, cognitive dysfunction, etc.).

Laborértékek

• 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;

Egyéb

• Have been ready for pregnancy during test, are lactating women;
• Ready to birth of men during the test;
• Subject with any immunodeficiency;
• Participate in any clinical subjects in nearly six months;
• Poor adherence to complete studies;

• 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 20/400.
• The BCVA of contralateral eye is not worse than 20/400.
• 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.