Thursday, November 19, 2009

Advanced Cell Technology Files IND With FDA For First Human Clinical Trial Using Embryonic Stem Cells to Treat Eye Disease

Source: Advanced Cell Technology, Inc.
Posted: November 19, 2009 10:00 AM ET

Summary:

In an official company news release, Advanced Cell Technology, Inc. a biotechnology company in the field of stem cell research, announced it has filed an application with the Food & Drug Administration to begin a study using embryonic treat patients with Stargardt’s Macular Dystrophy (SMD), a degenerative eye disease:

WORCESTER, Mass.--Advanced Cell Technology, Inc. announced today that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD). Among the most common causes of untreatable blindness in the world are degenerative diseases of the retina. As many as 10 million people in the United States have photoreceptor degenerative disease. While most of these patients have Age-Related Macular Degeneration (AMD), a smaller number of patients have Stargardt’s, an Orphan disease and one of the most common forms of juvenile macular blindness. The treatment for eye disease uses stem cells to re-create a type of cell in the retina that supports the photoreceptors needed for vision. These cells, called retinal pigment epithelium (RPE), are often the first to die off in SMD and AMD, which in turn leads to loss of vision.