Second U.S. human embryonic stem cell clinical trial gets green light

The U.S. Food and Drug Administration has approved Advanced Cell Technology for the second human trial of human embryonic stem cells (hESC), in people with macular degeneration, a progressive form of blindness.

Advanced Cell Technology said it would start testing its stem cell-based treatment on 12 patients with Stargardt’s Macular Dystrophy, which usually impacts children between 10 to 20 years of age, resulting in blindness due to degeneration in the retinal pigment epithelium (RPE). 

The company has created a technique to turn human embryonic stem cells into RPE cells.   The company removes a single human embryonic stem cell when the embryo, taken from those left over at fertility clinics, has about eight cells.

Geron Corp was the first to be allowed clinical trials and has enrolled the first patient, whose spinal cord had been crushed.

If it seems confusing that the court would strike down taxpayer funding for human embryonic stem cell (see Judicial Activism Is The Problem In The Embryonic Stem Cell Injunction) research yet the FDA allows clinical trials, it shouldn't be.    These are private companies and both those and state-funded agencies were always allowed human embryonic stem cell research, only the federal restrictions limit hESC research.

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