retinal pigmentosa
Conditions
Interventions
Case series:human RPE cells transplantation
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18-70 years male and female; 2) The clinical diagnosis was retinitis pigmentosa, and the results of eye electrophysiological examination accorded with retinitis pigmentosa. Priority mertk / RPE65 gene mutant patients; 3) The best corrected visual acuity of the operation eye will not be better than 0.12; 4) The best corrected visual acuity in the contralateral eye was not less than 0.12; 5) Diopter>-8.00D, axial length=28mm; 6) Voluntarily as subjects, sign informed consent, and be able to follow up regularly at the prescribed time.
Exclusion criteria
Exclusion criteria: 1) suffering from other ophthalmic diseases other than RP, such as age-related macular degeneration, diabetic retinopathy, optic neuropathy, significant opacity of the lens, glaucoma, uveitis, retinal detachment, etc.; 2) operation history of surgery eye; 3) active severe digestive diseases, liver and kidney function damage (ALT/AST> 1.5) or any known liver disease, creatine> 1.3 mg/dL) and / or serious systemic diseases such as cardiovascular system, Respiratory system, nervous system, endocrine system, genitourinary system, etc.), a history of malignancy; 4) Pregnant women, women who are preparing for pregnancy during pregnancy, actating women; during the test preparation of male fertility; 5) Any immunodeficiency; 6) Currently immunosuppressive therapy; 7) Those who are allergic to tacrolimus or other macrolides; 8) Participate in any clinical trial in the last 6 months; 9) history of abuse of alcohol or prohibited drugs; 10) poor compliance, difficult to complete the study of patients; 11) Some researchers think there may be any situation that increases the risk of the subject or interferes with the clinical trial (eg, patients are prone to mental stress, depression, mental illness, cognitive dysfunction, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity;ETDRS examination;OCT;ERG;Multifocal ERG;Fundus image;HRA autofluorescence;Fundus fluorescein angiography; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular pressure;Anterior segment image;microperimetry;Center and peripheral field of vision or Humphrey 24-2;A or B-ultrasound;Corneal endothelial count; | — |
Countries
China
Contacts
Public ContactWang Ningli
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed