445. cGMP Compliant Production for Human Embryonic Stem Cell Derived Retinal Pigment Epithelial Cells on a Synthetic Substrate for the Treatment of Non-Neovascular Age-Related Macular Degeneration for Phase I Clinical Study

P.M Lopez,T Aguilar,Rl Wu,A Krishnan,D Kong,J Patel,H Javier,W Dang,D Wong,D Zhu,J Dodd,Y Shad,M Humayun,D.R Hinton,D.O Clegg,L.V Johnson,C.M Lin,D Hsu,L Couture

doi:10.1016/s1525-0016(16)33254-3

445. cGMP Compliant Production for Human Embryonic Stem Cell Derived Retinal Pigment Epithelial Cells on a Synthetic Substrate for the Treatment of Non-Neovascular Age-Related Macular Degeneration for Phase I Clinical Study

P.M Lopez, T Aguilar + Show 17 more

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https://doi.org/10.1016/s1525-0016(16)33254-3

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Journal: Molecular Therapy	Publication Date: May 1, 2016
License type: cc-by-nc-nd

Affiliation: City of Hope, University of Southern California, University of California, Santa Barbara

#Retinal Pigment Epithelium #Transplantation Of Retinal Pigment Epithelium + Show 8 more

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Abstract

Non-neovascular age-related macular degeneration (dry AMD) is a leading cause of irreversible vision loss and is associated with retinal pigment epithelium (RPE) dystrophy. The RPE monolayer is integral for maintenance of healthy photoreceptors. Many studies have shown that AMD can be recovered by cellular therapy through transplantation of RPEs into the sub-retinal space to re-establish RPE functionality and halt neurological degeneration. Here we present a cGMP compliant manufacturing process to producing transplantable RPE cells on a synthetic substrate for clinical phase I study.

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