Differentiated human neural progenitor cellsIMAGE BY CAROL N. IBE AND EUGENE O. MAJOR, COURTESY OF NIHA woman in California recently made headlines when she grew superfluous bones in her eye socket after receiving a botched cosmetic procedure that involved injecting fat stem cells from her abdomen into her face. Hers is just one of the horror stories that have resulted from the use of unregulated, unapproved stem cell therapies in the U.S.
In July 2012, after several companies were found to be treating patients with unapproved stem cell therapies, the U.S. District Court in Washington affirmed the right of the FDA to regulate therapies made from a patient’s own stem cells. This was a good decision that will protect patients, strengthen efforts to develop new regenerative medicines and help to ensure the safety and therapeutic value of approved products.
A rising call to introduce appropriate oversight and regulation of stem cell therapy comes as no real surprise—the number of authorized cell therapy clinical trials has increased steadily in the U.S. over the past 10 years, from 12 trials initiated in 2001 to more than 50 trials initiated in 2011. While certain aspects of the US regulatory process ...
