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Entries in Geron Corporation (2)

Thursday
Nov172011

Geron Announcement Throws Stem Cell Research into Question

iStockphoto/Thinkstock(MENLO PARK, Calif.) -- In the wake of a California-based research company's decision to drop the world's first clinical trial using human embryonic stem cells, many investigators who once held to the promise of stem cell research now wonder whether the field of embryonic stem cell research has been abandoned in the U.S. completely.

The company, Geron, which pioneered the field of embryonic stem cell research, announced its decision on Monday to drop its study on stem cells for spinal cord injury.

Geron cited costs as the primary reason, saying the payoff of stem cell research wouldn't come close to other more lucrative projects.  The company would be better off allocating financial resources to research for cancer therapies that are near completion in development, company representatives said.

While Geron says it hasn't given up on the promise of stem cell research, many experts say the announcement signals a symbolic end to the era of embryonic stem cell research that many researchers worked so hard to launch.

Many experts say they're not convinced that financial limits are only to blame.

"This company would not walk away from this trial in the absence of an unexpected complication or safety concern, if there was any evidence that it was working," said Dr. Daniel Salomon, associate professor in the department of molecular and experimental medicine at the Scripps Research Institute in San Diego. "The assumption has to be that they designed a study with a purposeful plan to complete it to a certain benchmark of efficacy and that they had the funds for that effort in hand."

In 2009, the Obama administration lifted former president George W. Bush's restrictions on funding for stem cell research, which expanded the financial limits of the field.

Geron's trial on therapies for spinal cord injury became the first embryonic stem cell-based research approved in the U.S.

"Without seeing the data, one cannot be certain that there was not a clinical reason for stopping the trial," said Dr. Robertson Parkman, professor of pediatrics at the University of Southern California.

Copyright 2011 ABC News Radio

Monday
Oct112010

Genetics Company Begins First Embryonic Stem-Cell Treatment 

Photo Courtesy - Getty Images(NEW YORK) -- For years, scientists have held out the promise that embryonic stem cells could repair damaged spinal cords and cure other serious ailments.

Scientists Monday got one step closer to making that promise a reality as they began an embryonic stem-cell treatment on a patient with spinal cord injuries.  It is the first time a medical therapy has been used on a human in a government-approved study.

"This is the dawn of a new era in medical therapeutics.  We are leaving behind the days of using pills to treat symptoms, and entering a new era where we're using living human cells to permanently restore organ function damaged by a disease or an injury," said Tom O'Karma, president and CEO of Geron Corporation, the company conducting the trial.

It's a cautious start.  Scientists from Geron injected the first human subject Friday at the Sheperd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta -- one of seven potential sites in the country that can enroll patients in the new clinical trial for the therapy.  The company says it will add eight to 10 additional patients to the other national sites in the next year.

The company won Food and Drug Administration approval after showing promising results in lab rats.  Rodents with little use of their back legs and tails were able to walk again within weeks; the embryonic stem cells helped repair their damaged nervous system.

For now, the company is playing down expectations in the human trial.

"We can only admit one patient a month for the first few patients, so it will take about six months to a year before we have enough rigorous data to be able to say something about safety and any possible efficacy that we detect," O'Karma said.

If the stem cell therapy, which in this case is for the treatment of spinal cord injuries, is deemed safe, it will be seen as a milestone.  Improvement of the patients in this trial would be viewed as an astounding success.

However, if the treatment fails -- or worse, if patients die -- doctors said it will be a devastating setback for the use of embryonic stem cells.

"This is a huge milestone for the field, marking the first time a product of a human [embryonic stem cell] has been transplanted into a patient," said Dr. George Daley, director of Stem Cell Transplantation at Children's Hospital Boston and the Dana-Farber Cancer Institute in Boston.  "It has taken years and reams of regulatory documentation to get to this milestone.  I hope the trial proceeds safely and that this represents just the first of many trials to follow."

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