FDA Delays Company’s Bid for Human Embryonic Stem Cell Research Trials

Bioethics   |   Steven Ertelt   |   May 16, 2008   |   9:00AM   |   WASHINGTON, DC

FDA Delays Company’s Bid for Human Embryonic Stem Cell Research Trials

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by Steven Ertelt
LifeNews.com Editor
May 16
, 2008

Washington, DC (LifeNews.com) — The Food and Drug Administration has delayed a request from a biotech company wanting to engage in human trials with embryonic stem cells. While adult stem cell research has already helped patients with dozens of diseases, embryonic stem cells have never been tried in humans.

That’s because embryonic stem cells have significant problems when used in animals.

They tend to form tumors after the cells are injected as a treatment and immune systems reject the cells as foreign. Neither problem occurs with the use of adult stem cells.

FDA officials met with representatives of Geron Corp. and Advanced Cell Technology Inc. last month to discuss the possibilities. Both companies have been claiming for years they were ready to start human trials but pro-life advocates are concerned problems still remain.

Yet, 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.

On Wednesday, the FDA notified Geron’s chief executive Thomas Okarma that the company cannot proceed and indicated a letter with more explanation about the decision is forthcoming.

The decision is likely only to delay the human trials rather than to stop them from proceeding eventually.

Okarma told the New York Times he is disappointed by the decision.

“We are disappointed with this action given the interactions we had with the F.D.A. over four years leading to the filing” of the request for human trials.

Wesley Smith, an attorney and bioethics watchdog, responded to the news.

"Geron Corporation has released a series of press releases over several years stating that ‘next year’ it would start the first human trials using ES cells. Apparently, that won’t be happening yet," he said.

"Tumors are an important worry, as is efficacy. Meanwhile, those adult stem cell advances keep rolling in," he added.

After learning of the application for the embryonic stem cell research trials, Sen. Sam Brownback, a leading pro-life advocate, urged the FDA to reject the requests.

Brownback says there are moral issues involved and medical risks for patients.

Brownback said the embryonic stem cell trials could easily put patients at risk and pointed to "devastating patient results" with trials several years ago involving fetal tissue from babies victimized by abortion.

"The problem was the cells were too immature and tended to form tumors or grow in uncontrolled ways that could not be reversed in the humans who underwent experimentation," the senator explained.

"Human beings are not guinea pigs," he adding, calling any decision to allow the companies to proceed "irresponsible."

Brownback said human trials involving embryonic stem cell research are unnecessary given the enormous success scientists have had with adult stem cells.

“What makes this even more troubling is that there is a viable ethical alternative with adult stem cells," he said.

"They are currently being used in the treatment of well over 70 different diseases and conditions, including spinal cord injury, type-I diabetes, heart failure, and Parkinson’s disease as validated by peer-reviewed, published results."