Korea's firstIntegrated Stem Cell Bank
Bio Insurance
Korea's firstIntegrated Stem Cell Bank
Bio Insurance
Korea's firstIntegrated Stem Cell Bank
Bio Insurance
Korea's firstIntegrated Stem Cell Bank
Bio Insurance
Korea's firstIntegrated Stem Cell Bank
Bio Insurance
Global CHA Network
| Classification | Retinal Pigment Epithelial Cells (hES-RPE) | ||
| Indication | Stargardt’s Macular Dystrophy (SMD) | Age-related Macular Degeneration (AMD) | Myopic Macular Degeneration (MMD) |
| Significance | - World's first commercialization of embryonic stem cell therapy - Fundamental treatment for Macular Degeneration |
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| Characteristics | - Leads to gene mutation cause vision loss | - Affects older adults and results in loss of vision due to retinal damage - Increases patients as population aging |
- Occurs retinal abnormalities in serious short-sightedness |
| Progress | - 2009 : Partnered with ACT (U.S) to introduce pipeline - 2010 : Received an orphan drug designation from U.S. FDA (Benefits include 7-year marketing exclusivity, tax credits, grants for clinical development, accelerated FDA approval, drug approval) |
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| - Clinical trial approval from U.S.FDA (2010.11) - Clinical trial approval from Korea MFDS (2011.05) |
- Clinical trial approval from U.S. FDA (2011.01) - Clinical trial approval from Korea MFDS (2012.05) |
- Clinical trial approval from U.S. FDA (2013.02) - Clinical trial approval from Korea MFDS (2013.10) |
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| Procedure | - Step 1 : Vitrectomy surgery - Step 2 : Subretinal transplantation of human embryonic stem cell-derived retinal pigment epithelial cells |
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| Outcome | - No safety issues related to the transplanted cells - Improved ETDRS visual acuity among subjects - Korea Study: 9-19 letters improvement in 3 patients from 4 patients analysis - U.S. and Europe Study: >15 letters improvement in 6 patients from 18 patients analysis |
- Clinical trial in progress | |
