Monday, February 11, 2008

Embryonic Stem Cell Trials in Humans Could Begin in Months

If all goes as planned, a California biotech firm will begin human testing using human-based embryonic stem cells by Spring of 2008.

Dr. Thomas Okarma, CEO of Geron, said the firm plans to conduct embryonic stem-cell studies in subjects with spinal cord injuries, involving up to 40 patients. The planning, of course, is pending the greenlight to proceed from the FDA, which is said to be setting a "high bar" on regulations governing what is certain to be one of the most significant pioneering research procedures of the century. Economic analysts predict the regulatory process alone will be daunting, and time-consuming because these are uncharted waters. It will be the first time that the FDA reviews a human embryonic stem-cell application.

Controversy has raged on both sides over the debate of stem cells and the ethical use in human therapeutic applications. In 2001 President Bush placed limits on federal funding of experiments involving then-existing human-derived stem cell lines, and in 2007 vetoed an attempt by Congress to lift those restrictions. No doubt the impending research will only raise more ire, questions and a major regulatory conundrum of the likes never witnessed before.

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