In a setback for thousands of spinal injury patients who had placed their hope in embryonic stem cell research, a clinical trial involving Atlanta’s Shepherd Center has been discontinued.
Geron Corp. of Menlo Park, Calif., which invested 15 years and $150 million developing the treatment, said Tuesday that it can no longer sustain the costs of research. The trial on four patients, including two at the Shepherd Center, was the first government-approved attempt to test a therapy using human embryonic stem cells.
Keith Tansey, the study’s principal investigator and director of spinal cord injury at Shepherd, said the year old trial succeeded in demonstrating that Geron’s process for implanting embryonic stem cells is safe. It was “a home run,” he said, because the patients experienced no adverse effects.
Tansey said he expects another company to capitalize on the advances made thus far. “I’m sure someone will pick up the ball and run the next 10 yards.”
But Geron’s decision demonstrates the difficulty of bringing this cutting-edge technology to the market, other researchers said. It may be hard to find another company with deeper pockets ready to step into the effort.
“The pioneers can sometimes pay the price,” said Lee Rubin, director of Translational Medicine at the Harvard Stem Cell Institute.
The announcement won’t necessarily put a damper on the entire field, but it may sound a note of caution for companies interested in stem cell therapy, he said.
Spinal cord injuries are a particularly expensive and complex challenge –- especially for a relatively small company such as Geron, Rubin said. Other companies may choose a less risky path by focusing on conditions with which there is a better chance of medical success, he said.
"It was wonderful that Geron took on the challenge of developing breakthrough technology to treat people with no other options, but that doesn’t make it any easier to do," Rubin said.
Only one other trial involving embryonic stem cells has won government approval. It involves a treatment for macular degeneration, an eye disease far more common than spinal injuries.
The Shepherd Center is responsible for the rehabilitation of first person to be injected with human embryonic stem cells, Patient A, who underwent the surgery in October 2010. He is T.J. Atchison, a 21-year-old former high school football player who is studying nursing at the University of South Alabama.
Atchison decided to reveal his identity after he learned from the news that the therapy he was receiving at Shepherd was pathbreaking -- and that it was controversial.
The boyish native of Chatom, Ala., was paralyzed from the chest down after he broke his neck in a car crash last year. He suffered a complete break at the T7 disc in his upper back. As he recuperated at Shepherd following the accident, he heard his treatment being discussed on the national news, and being criticized by those who believe using embryonic cells is immoral.
"How can you be upset with anyone being able to walk?" he told AJC reporter Bill Torpy. "People are rooting for me."
Atichson could not be reached for comment Tuesday.
Dan Becker, president of Georgia Right to Life, described the embryonic cell therapy Tuesday as "destroying human life without any advances to our scientific knowledge." He said investors are slow to back such treatments because they represent a "blind alley." Becker touted research into "adult stem cell" treatments, which he said have been used for 50 years to treat leukemia.
But Tansey, at Shepherd, said there are no "adult progenitor" stem cell treatments for acute spinal cord injuries, and that embryonic cells, while more complex, hold great promise.
He noted that the fertilized ova that provide embryonic stem cells come from fertility clinics and typically are discarded if not used for research. "It's ironic that its OK to throw away fertilized embryos in fertility clinics but not to use them to better the quality of life for people suffering from injury and disease," he said.
Instead of stem cell research, Geron plans to focus its limited resources on two cancer therapies that could hit significant clinical trial milestones in less than two years, CEO John Scarlett said in a statement. “This would not be possible if we continue to fund the stem cell programs at the current levels,” Scarlett said.
Eliminating the stem cell program will eliminate 66 jobs, or 38 percent of the company’s workforce.
Geron is searching for partners with more resources to continue developing the research and has been in talks with companies over the past several months, said spokeswoman Anna Krassowska .
“We don’t see this as the end,” she said.
Any partnership deals would involve licensing the patents Geron holds, she said. The company will also keep a small core team of employees who worked on the stem cell project through the end of the second quarter of 2012 to help with the transition, according to the company’s statement.
While it will close enrollment in the clinical trial, the company will continue to follow the four patients already in the study for another 15 years, she said
“We want to see this … therapy further developed,” Krassowska said.
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