Wisconsin Stem Cell Now: FDA approves first human embryonic stem cell trial

Contact: Sachin Chheda, 414-412-6099

Ed Fallone, 414-412-5772

MILWAUKEE – The U.S. Food and Drug Administration has approved the first human trial of an embryonic stem cell treatment in the country – a milestone in the development of this promising form of medical research.

The FDA authorized Geron Corp., a California-based biopharmaceutical firm, to implement embryonic stem cell treatments for up to ten patients with spinal cord injuries. The study will provide treatment to patients who have been paralyzed within fourteen days for at least a year, during which time their progress will be monitored.

“Today’s news is a significant milestone in the translation of new discoveries in cell biology into life saving cures,” said Ed Fallone, President of Wisconsin Stem Cell Now. “It underscores the amazing potential of embryonic stem cell research to transform the lives of thousands of Wisconsinites and their families who struggle with chronic disease and disability.”

The FDA reviewed the proposal from Geron for over a year before deciding to authorize it. The study will focus on the safety of embryonic stem cell treatments as well as their effectiveness.

Embryonic stem cell research, which has been severely limited by the federal government since an executive order from former President Bush in 2001 restricted federal funding, has the potential to cure not only physical ailments like spinal cord injuries, but diseases like Parkinson’s, Alzheimer’s, and diabetes.

“While some may argue that today’s announcement is proof that the private sector can support embryonic stem cell research without the use of federal dollars, these arguments are misguided,” Fallone said. “Profit motive is a poor engine for medical research, and many genetic diseases do not afflict a large enough population to create a profitable ‘market’ that would justify the investment of millions of dollars in research by a private company.

“In fact, the lack of federal funding for basic embryonic stem cell research has deterred many researchers from entering the field. How many more therapies would be undergoing FDA trials now, if only federal funding of embryonic stem cell research had been available? Hopefully, with the new administration in Washington, our federal government will put its efforts behind accelerating the pace of the search for cures, rather than on placing ideological roadblocks in front of scientists.”