Posts Tagged ‘U-Dub Madison’
Thumbs-up from FDA for stem cell study in humans
More than a decade after a University of Wisconsin-Madison lab first showed the therapeutic viability of human embryonic stem cells, the U.S. Food and Drug Administration (FDA) today (Jan. 23) approved the world’s first study using embryonic stem cells in humans.
Geron, the California-based biotech company who financed the original 1998 UW-Madison studies leading to the breakthrough, will now begin to test stem cells in people with severe spinal cord injuries. The announcement sent Geron’s company shares up over 40 percent during the trading day , which MarketWatch reported was the company’s biggest percentage surge since January 1998.
With the proper chemical nudging embryonic stem cells can become any cell type in the body, offering a potential therapeutic goldmine as a replacement for dying cells caused by disease, injury or old age.
Only a few years after scientists determined a way to isolate and maintain human embryonic stem cells, scientists found themselves pulled into a heated ethical battle. In 2001, former President George W. Bush created an Executive Order banning the use of federal money for any newly generated lines of stem cells due to his opposition to the destruction of viable embryos. This ruling essentially handcuffed stem cell researchers across the country.
Scientists from Geron and the University of California at Irvine coaxed stem cells from the lines created before the ban went into effect to become supporting neural cells called oligodendrocytes. The researchers found that paralyzed rats receiving injections of the newly generated cells seven days post-injury showed improve locomotor activity.
The FDA-approved study, a Phase I clinical trial that will measure the safety of embryonic stem cell treatment in humans, will be a small trial of a maximum of 10 patients with severe spinal injuries. Doctors will treat patients with injections of oligodendrocytes at the site of injury within seven to 14 days post-injury, the narrow window of time where the stem cell therapy showed the highest efficacy in rodents.
Geron originally requested FDA approval to test the therapy in clinical trials back in March 2008. According to The New York Times, the FDA first declined Geron, saying more data was needed. But now, just days after the inauguration of President Barack Obama, Geron received the FDA’s nod to proceed. Today’s announcement fueled speculation among scientists that political oversight by the Bush administration was to blame for the delay, and the swift approval may be a sign that Obama will soon move to relax federal restrictions on stem cell research.
Though many see the federal approval of the Geron trial as a huge step for stem cell research, scientists stress even if all goes well and the treatment proves to be safe, years of hurdles exist ahead before stem cell therapy would be available to all patients with spinal cord injuries.
