Human stem cell trial discontinued

"First test of human embryonic stem cell therapy in people discontinued," The Washington Post. November 14, 2011--The company conducting the first government-approved tests in people of a therapy developed using human embryonic stem cells abruptly announced Monday that it was halting the study, stunning advocates of the highly contentious field. Geron Corp. of Menlo Park, Calif., said the move, which stops one of the most controversial and closely watched medical experiments in the history of biomedical research, was the result of a business decision to focus exclusively on developing cancer therapies. Another company continues to test a second embryonic stem cell therapy in people. But Geron’s announcement marked a major setback and disappointment, researchers and advocates said. “While stem cells are proving invaluable for research, translating the promising science into new therapies is a slow, painstaking process with many setbacks,” said George Q. Daley, a leading stem cell researcher at Harvard Medical School. “A safe first trial would have paved the way for many others to follow.” Human embryonic stem cell research has been the focus of intense excitement and acrimonious public debate, but it has so far shown promise only in animal and laboratory studies. The Geron study was the first government-sanctioned attempt to test a therapy using the cells in people.

The field is fraught with political, moral and ethical controversies. Days-old embryos have been destroyed to obtain the cells, which critics consider immoral. After many delays, the Food and Drug Administration last year approved two experiments testing therapies created from embryonic stem cells in humans, including a study testing Geron’s experimental treatment on 10 patients partially paralyzed by spinal cord injuries. Both studies were designed primarily to determine whether the approach is safe. The studies have been seen by supporters and opponents of embryonic stem cell research as potentially pivotal to the future of the research. Some worried that not enough basic studies and tests had been done in animals before injecting cells into recently paralyzed patients. Others wondered whether patients who are struggling to come to terms with a devastating injury can make the risky decision to volunteer for the study within two weeks of such a trauma, one of the terms of participation.

Opponents of the research pointed to the announcement Monday as evidence of doubts about the research. The decision “may also indicate that it is not as promising as previously described, both in terms of commercial development as well as safety and efficacy,” said David Prentice of the Family Research Council. Proponents dismissed such arguments.

Senior Fellow for Life Sciences, Center for Human Life and Bioethics David Prentice, PhD: "It's highly unusual for a trial to be abruptly canceled in the absence either of serious adverse events or of overwhelming positive results. The economic excuse rings hollow, especially after a promised $25 million from California, the $750,000 from the federal government through Obamacare and repeated hype to investors.

"It is very likely that Geron's ethically-questionable embryonic stem cell trial is just not nearly as promising as the pro-ESC lobby has portrayed, not only in terms of commercial viability but perhaps also in terms of safety. What little we’ve been told is that there were 'no serious adverse events' and that patients showed no improvement. While it may be too early (only one year since the first patient was injected) to see tumor formation, the early indications may have been enough for Geron to decide to get out of the embryonic stem cell field now.

"Indeed, they are dropping not only the current trial, but all of their embryonic stem cell work. In the meantime while the media continue to push the dubious 'potential' of embryonic stem cells, most people (including most physicians) have still not heard about the peer-reviewed results documenting not only safety but also effectiveness of adult stem cells. The published efficacy shows benefit to patients for conditions such as spinal cord injury, acute and chronic heart conditions, multiple sclerosis and dozens of others. This was the message delivered repeatedly by doctors discussing their own trials at a recent international conference on adult stem cells. The real promise for patients is with ethical and successful adult stem cells."

Resources
CMDA Ethics Statement: Human Stem Cell Research and Use
Stem Cell Fact Sheet