Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa
NCT ID: NCT03944239
Last Updated: 2020-03-26
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
10 participants
INTERVENTIONAL
2020-05-31
2021-12-31
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 epitheliums transplantation
Transplant clinical-grade hESC derived retinal pigment epitheliums into subretinal of patients with retinitis pigmentosa.The dosage is 150000.
Retinal pigment epitheliums transplantation
Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.
Interventions
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Retinal pigment epitheliums transplantation
Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* Poor adherence to complete studies;
* 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.).
18 Years
80 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Qi Zhou
OTHER_GOV
Responsible Party
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Qi Zhou
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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Beijing Tongren Hospitol,Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ChineseASZQ-002
Identifier Type: -
Identifier Source: org_study_id
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