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 Other
Start date (estimated) 2015-09-20
End date (estimated) 2017-12-20
Clinical feature
Label retinitis pigmentosa
Link http://purl.obolibrary.org/obo/DOID_10584
Description A retinal degeneration characterized by the gradual deterioration of the photoreceptors or the retinal pigment epithelium of the retina leading to progressive sight loss.; Xref MGI. OMIM mapping confirmed by DO. [LS].

Administrative Information

Other study identifiers
Name ChiCTR-OCB-15007055
Description Chinese Clinical Trial Registry (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

Cells

Which differentiated cell type is used
Label retinal pigment epithelial cell
Link http://purl.obolibrary.org/obo/CL_0002586
Description An epithelial cell of the retinal pigmented epithelium.

Recruitment

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