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

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. 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.
Clinical trials phase Phase 1
Start date (estimated) 2020-05-01
End date (estimated) 2021-12-31
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
NCT number NCT03944239
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03944239
Other study identifiers
Name ChineseASZQ-002
Source weblink https://clinicaltrials.gov/ct2/show/NCT03944239
Study sites
Public contact
Email wangliu@ioz.ac.cn
Public email wangliu@ioz.ac.cn
First name Liu
Last name Wang
Country
China
Sponsors Qi Zhou
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 Unknown Status
Estimated number of participants 10
Contact institutions/departments