Company Claims First Patient Treated With Embryonic Stem Cells, Not The Case

Bioethics   |   Steven Ertelt   |   Oct 11, 2010   |   9:00AM   |   WASHINGTON, DC

Company Claims First Patient Treated With Embryonic Stem Cells, Not The Case

by Steven Ertelt Editor
October 11
, 2010

Washington, DC ( — Geron Corporation, a California-based firm that conducts embryonic stem cell research and has a history of making dubious announcements to see a boost in its stock price and reputation, is apparently at it again. The firm has announced it has treated the first patient with embryonic stem cells.

However, the patient did not receive an injection of actual embryonic stem cells — because scientists have still not been able to overcome significant problems in their use with animals.

Specifically, the cells, once injected, cause tumors and are rejected by the immune system.

But that didn’t stop Geron from announcing today that it injected the cells into the first patient ever under the first clinical trial authorized by the Food and Drug Administration and the Washington Post, in a story posted today, repeated the false claim.

"The first patient has been treated with human embryonic stem cells in the first study authorized by the Food and Drug Administration to test the controversial therapy," the Post claimed. "A patient who was partially paralyzed by a spinal cord injury had millions of embryonic stem cells injected into the site of the damage."

However, former Indiana State University biology professor and Family Research Council fellow Dr. David Prentice says that’s not the case.

He told the situation is "a bit confusing" but the cells are not truly human embryonic stem cells but ones that "are directly derived from embryonic stem cells, and rely on embryonic stem cells."

Prentice accused Geron of falsely promoting its work as embryonic stem cell trials when derivatives are used instead.

"Geron is irresponsibly trying to do science by press release, publicizing that they have begun their human experiment by injecting a patient with potentially dangerous cells made from embryonic stem cells," he said.

"Their press hype will help their stock price, but not science and not patients. We hope the patients don’t suffer any ill effects, but it will be years before there is hard evidence about safety or effectiveness," Prentice continued.

The patient involved in the trial was treated at the Shepherd Center in Atlanta, which is one of seven locales nationwide where Geron is trial the injections.

Prentice said if Geron truly wanted to help patients, it would stick to research and trials involving adult stem cells — which are already helping patients now who are battling dozens of diseases and medical conditions.

He said "adult stem cells have published real scientific evidence for effectively treating spinal cord injury."

The Food and Drug Administration had initially placed the trial on hold but Geron indicated in July that the agency approved it.

The FDA placed a hold on the trial in August 2009, when evidence showed Geron’s GRNOPC1 encountered safety issues when used in animal studies. Geron’s own data showed higher frequency of small cysts within the injury site in the spinal cord of animals injected with the embryonic cells.

Prentice previously elaborated on the derivative nature of the cells.

"They inject cells derived from embryonic stem cells; in this case a cell type called an oligodendrocyte, which is a cell that forms a sheath, like insulation, around nerve fibers," he said. "So they don’t inject growing embryonic stem cells, but the cells are indeed directly derived from embryonic stem cells, and actually are not completely differentiated, but only part-way ("precursors")."

"The theory is that once inside the body, the cells will finish specializing to the final cell type, and form an insulative covering over exposed nerves in the spinal cord," he told

Prior to the FDA approval, scientists expressed concerns about Geron’s trial.

Before FDA approval, Dr. John A. Kessler, chairman of neurology and director of the stem cell institute at Northwestern University, said the first application from Geron for the embryonic stem cell trial was flawed.

“We really want the best trial to be done for this first trial, and this might not be it,’’ he said at the time.

In August 2008, Evan Snyder, a neuroscientist who heads up the stem cell research center at the Burnham Institute for Medical Research in San Diego, warned the research may not be ready for humans.

"There’s a lot of debate among spinal cord researchers that the pre-clinical data itself doesn’t justify the clinical trial," Snyder, who is working on using neural stem cells himself, said then.

Snyder said then the mice Geron used to conduct pre-human trial research had more excessive injuries that scientists would normally prefer to see prior to trying the procedure on human patients.

He suggested that Geron should have done experiments involving larger animals before seeking FDA permission to use the controversial embryonic stem cells in humans.

Those concerns existed as early as 2005 and may not have been addressed.

Snyder said then that Geron should do more animal testing first to make sure the tests would be on the same injuries humans have.

"I’m not convinced they have done that yet," Snyder said.

Jerry Silver, a neuroscience professor and stem-cell researcher at Case Western Reserve University in Cleveland, told Knight Ridder back in November 2005 that Geron was moving too fast and needed to do more tests on animals before seeking human patients.

"Frankly, I cannot conceive of a human trial with the use of human embryonic stem cells following immediately from experiments in rodents only," he said then. "Many treatments that work in rodents to alleviate disease fail miserably in humans."

The news of the trial comes as the Obama administration is doing battle with scientists over forcing taxpayers to finance embryonic stem cell research.


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