FDA Examining Requests to Use Embryonic Stem Cells in Human Trials

Bioethics   |   Steven Ertelt   |   Apr 10, 2008   |   9:00AM   |   WASHINGTON, DC

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by Steven Ertelt
LifeNews.com Editor
April 10
, 2008

Washington, DC (LifeNews.com) — The Food and Drug Administration is considering a request from two biotech companies to begin human trials involving human embryonic stem cells. The two companies involved have been claiming for years they were ready to start human trials but pro-life advocates are concerned problems still remain.

Embryonic stem cell research has not yet been successful in animals because of two significant reasons.

Unlike adult stem cells, when embryonic stem cells are injected as a treatment they form tumors and the immune system rejects the foreign cells.

Yet, Geron Corp. and Advanced Cell Technology Inc. both say they plan to start human trials this year and are requesting FDA approval to do so. Both claim to now have tumor-free experiments involving animals.

Dave Prentice of the Family Research Council and a former biology professor at Indiana State University, tells CNN he opposes human trials because of the significant risks involved that will put patients at risk. He also emphasized the moral issues involved.

"You shouldn’t be destroying human embryos at the earliest stage of human life to harvest cells," the biochemist with a Ph.D. from the University of Kansas said.

According to a Bloomberg News report, FDA officials want staff at the biotech companies to closely monitor whether the tumor or immune system problems crop up when they inject the cells into patients who are totally or partially paralyzed.

Carol Pratt, a FDA and regulatory attorney with a Portland, Oregon law firm told Bloomberg, "The FDA officials are deer in the headlights, caught between the tensions of the public" and the desire of scientists to proceed.

She also said patients have the seemingly contradictory concerns of wanting treatments soon and needing thorough safety requirements.

"Don’t stand in the way of new medical therapies, and for God’s sake, don’t let any American get hurt," Pratt said of the competing interests. "They don’t know where to draw the line on stem cells right now, and there’s no way they would.”

Bioethics expert Wesley J. Smith also commented on the recent developments.

"Whether actual human trials with embryonic stem cells will happen remains to be seen–Geron has been claiming trials will come next year for at least the last four," he said.

With the FDA facing heightened criticism over several drugs causing major medical issues, federal officials may move slowly in approving the request for human trials.

FDA officials are meeting with representatives of both biotech companies today and tomorrow to discuss the possibilities.