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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03944239
• Date of registration: 27/12/2018
• Prospective Registration: Yes
• Primary sponsor: Qi Zhou
• Public title: Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa
• Scientific title: Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa
• Date of first enrolment: May 2020
• Target sample size: 10
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03944239
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Wang Liu, Doctor

• Name: Wei wen bin, Doctor

• Name: Zhou Qi, Doctor
• Affiliation: Institute of zoology, Chinese Academy of Sciences

Key inclusion & exclusion 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 20/400.

- 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:

- 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;

- 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.).



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Retinitis Pigmentosa

Intervention(s)

Biological: Retinal pigment epitheliums transplantation

Primary Outcome(s)

Adverse events and serious adverse events occurred within 1 year after transplantation [Time Frame: one year]

Secondary Outcome(s)

Improvement of visual function [Time Frame: one year]

Secondary ID(s)

ChineseASZQ-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beijing Tongren Hospital