Clinical study of subretinal transplantation of clinical human embryo stem cell derived retinal pigment epitheliums in treatment of retinitis pigmento diseases

General Information

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.
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.
Clinical trials phase Phase 1
Start date (estimated) 2015-09-20
End date (estimated) 2017-12-20
Clinical feature
Label Retinitis Pigmentosa
Link http://purl.obolibrary.org/obo/NCIT_C85045
Description A rare inherited retinal dystrophy disorder characterized by spots of black bone-spicule pigmentation of the retinal pigment epithelium. It is manifested with decreased vision in low light or in the night, followed by decreased peripheral vision, and, eventual decreased central vision. It may lead to blindness.

Administrative Information

Other study identifiers
Name ChiCTR-OCB-15007055
Description ChiCTR
Source weblink http://www.chictr.org.cn/hvshowproject.aspx?id=3681
Regulatory body approval
Name National Health Commission of the PRC;National medical products administration
Country
China
Approval number CMR-20181112-1001
Study sites
Public contact
Email wangliu@ioz.ac.cn
Public email wangliu@ioz.ac.cn
First name Liu
Last name Wang
Country
China
Sponsors Chinese Academy of Sciences
Collaborators

Cell Line

Recruitment

Recruitment Status Recruiting
Estimated number of participants 10
Contact institutions/departments