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

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

Sponsors

Lead Sponsor: Qi Zhou

Collaborator: Beijing Tongren Hospital

Source Chinese Academy of Sciences
Brief 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.

Detailed 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.

Overall Status Recruiting
Start Date May 2020
Completion Date December 2021
Primary Completion Date October 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Adverse events and serious adverse events occurred within 1 year after transplantation one year
Secondary Outcome
Measure Time Frame
Improvement of visual function one year
Enrollment 10
Condition
Intervention

Intervention Type: Biological

Intervention Name: Retinal pigment epitheliums transplantation

Description: Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.

Arm Group Label: retinal pigment epitheliums transplantation

Eligibility

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.).

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Zhou Qi, Doctor Principal Investigator Institute of zoology, Chinese Academy of Sciences
Overall Contact

Last Name: Wang Liu, Doctor

Phone: +86-01064807858

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Beijing Tongren Hospitol,Capital Medical University Wei wen bin, Doctor +86-01058265736 [email protected]
Location Countries

China

Verification Date

March 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Chinese Academy of Sciences

Investigator Full Name: Qi Zhou

Investigator Title: Director of Institute of zoology, chinese academy of sciences, and vice president of medical school, University of chinese academy of sciences

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: retinal pigment epitheliums transplantation

Type: Experimental

Description: Transplant clinical-grade hESC derived retinal pigment epitheliums into subretinal of patients with retinitis pigmentosa.The dosage is 150000.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov