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

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03944239
• Other study ID #: ChineseASZQ-002
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2020
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: Chinese Academy of Sciences
• Contact: Wang Liu, Doctor
• Phone: +86-01064807858
• Email: wangliu[@]ioz.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Biological:
• Retinal pigment epitheliums transplantation
Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.

Locations

Country	Name	City	State
China	Beijing Tongren Hospitol,Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Qi Zhou	Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and serious adverse events occurred within 1 year after transplantation	The occurrence of adverse events (AE), severe adverse events (SAE), treatment-related adverse events (TEAE), and clinically significant vital signs during the study period.	one year
Secondary	Improvement of visual function	The changes of BCVA and EDTRS were observed one year after surgery.	one year