Controversial Human Cloning Company Applies Again for Embryonic Stem Cell Trial

Bioethics   |   Steven Ertelt   |   Nov 20, 2009   |   9:00AM   |   WASHINGTON, DC

Controversial Human Cloning Company Applies Again for Embryonic Stem Cell Trial

by Steven Ertelt Editor
November 20
, 2009

Washington, DC ( — Advanced Cell Technology is at it again. The human cloning company that thrives on overstated press releases that capture the media’s attention and temporarily drive up its stock prices is announcing yet another attempt at launching a trial with patients receiving injections of embryonic stem cells.

Never mind that embryonic stem cell research has yet to conquer animal testing.

There, the cells face immune system rejection issues that scientists have yet to figure out how to overcome and they also still have problems of causing tumors after injected as a supposed treatment.

Those results are much different from those seen in ethical adult stem cells that can be obtained without destroying days-old unborn children.

Still, ACT presses on and announced that people suffering from a form of incurable blindness could soon become the first patients in the world to benefit from an operation involving embryonic stem cells.

ACT scientists yesterday applied for a licence from the Food and Drug Administration (FDA) to carry out a clinical trial on patients suffering from macular degeneration and they expert the trial to begin early next year.

"We’ve seen absolutely no adverse effects whatsoever in any of the preclinical experiments and our cells are more than 99.9 per cent pure," ACT chief scientific officer Robert Lanza claimed in an interview with the London Independent.

"We certainly expect them [the FDA] to come back with comments and questions but our hope is that we will start sometime early next year. We’re optimistic and certainly confident in our own data. We’ve been in dialogue [with the FDA] and we know what was on their mind and what they wanted us to do," he said. "We’re hoping, assuming no hitches, to begin early next year, perhaps March."

David Prentice, a former Indiana State University science professor who is now a fellow at the Family Research Council, emailed about the request.

"It’s a lot of excitement over paperwork. Because that’s all this is, filing paperwork hoping for FDA approval to some day experiment with human patients. In the meantime, no headlines or stock price jumps have happened when adult stem cells have already helped thousands of patients," he said.

When rival cloning company Geron pursued embryonic stem cell research trials in human patients last year, one doctor told TheStreet that the company was silly for saying so.

"The fact that Geron’s entire study hinges on this one experiment in eight moderately injured rats is tenuous in terms of efficacy," he said.

"We don’t know what will happen when these cells are placed into a human, which is the reason immune suppression is required," said the doctor.

"The risk is that these are not patients you would otherwise want to have on immune suppressants because the severity of their spinal cord injuries, the trauma they’ve suffered, their surgery and wounds make them more susceptible to infection," he added.

"If one patient gets a tumor from the Geron therapy, it will be catastrophic," said the doctor

The FDA ultimately made the decision to stop human trials involving embryonic stem cells when Geron came calling.

The FDA delayed the trials to review studies of the therapy, called GRNOPC1, in its use with animals.

Later reports indicated problems associated with the animals in Geron’s studies prompted the FDA to halt the human trials. Specifically, the animals developed cysts at the injury sites after the injections.

At the time, Wesley J. Smith, a bioethicist, said he thinks the research done on humans using cells from aborted babies showed eventual problems and he believes the FDA needs to significantly slow down Geron’s plans to proceed quickly.

"You know, tumors formed in a child given fetal cell treatments three years after the injection, and so I wonder how long an animal would have to be followed to determine safety," he said.

"And we can’t forget that the company apparently has not tested the product in large animals, and so there is some swimming in the dark here," he added. "Nevertheless, the FDA did the right thing here in terms of pure safety."

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