Advanced Cell Technology Receives FDA Clearance For Clinical Trials Using Embryonic Stem Cells to Treat Age-Related Macular Degeneration

Business Wire

Advanced Cell Technology, a biotechnology company based in Marlborough, Massachusetts which specializes in the development and commercialization of cell therapies for the treatment of a variety of diseases has been awarded FDA clearance to begin a clinical trial implementing human embryonic stem cells (hESCs) to treat Age-Related Macular Degeneration (AMD).

AMD has two forms, wet and dry, dry AMD being the most prominent, accounting for almost 90% of AMD cases. Dry AMD is the leading cause of blindness in people over the age of 55. Blindness results from the loss of retinal pigment epithelial cells, a single layer of six hexagonal cells just outside the neurosensory retina, responsible for nourishing the macula, the part of the eye responsible for high acuity vision.

The Phase I/II clinical trial will be performed at the Jules Stein Eye Institute at UCLA and the Opthalmology Department at the Stanford School of Medicine. The trial will determine the safety and efficiency of the RPE cells following sub-retinal transplantation. The proposed therapy uses RPE cells derived from hESCs to replace the diminished levels of RPE cells in the diseased patient. The company hopes to show that the RPE cells can be injected into to the retinal space in order to slow or halt the progression of AMD.

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