Stem cell therapies have the potential to treat some of the deadliest diseases that afflict mankind. Stem cells offer hope to people suffering from conditions for which there are no treatments or very few treatments. The promise that these “master” cells hold to repair, regenerate, replace, and restore all types of tissues and cells in the body has immense implications for the future of medical science. Yet, there is increasing worldwide concern that desperate patients are vulnerable to dishonest providers offering unproven, potentially harmful, and illegal stem cell treatments.
Regulation of Stem Cell Therapies in the USA
In the United States, the Food and Drug Administration (FDA) regulates stem cell treatments and ensures they are effective and safe. Stem cells are routinely used in bone marrow transplants to treat certain disorders such as blood cancers. Umbilical cord blood is a rich source of stem cells. A sample of cord stem cells can be isolated and frozen for future use. The FDA has issued regulations regarding cord blood banking. To receive FDA approval, companies creating stem cell therapies must demonstrate the manufacturing process to ensure the safety, efficacy, potency, and purity of the stem cell product.
International Regulation of Stem Cells
Around the world, experts are calling for urgent, coordinated, international regulatory efforts to curb potentially dangerous stem cell treatments. Stem cell tourism has become increasingly popular where patients travel to foreign countries to receive stem cell treatments at unregulated clinics – clinics that are essentially selling hope to the desperately ill. However, experts from the United States, Canada, Britain, Australia, Belgium, Germany, Italy, and Japan say that this is a dangerous trend. Stem cell treatments abroad are used on medical tourists before they have been fully evaluated for safety and efficacy. Clinics in unregulated countries use exploitative marketing to sell unproven stem cell therapies which have resulted in a number of deaths.
Stem Cell Watchdog
From his lab at the University of California Davis campus, Paul Knoepfler has written a blog called The Niche for several years, offering information to the general public and researchers about everything related to stem cells. Although his lab is located in the Shriners Hospital for Children building, Knoepfler is not a physician. Rather, he is studying stem cells and their association with cancer. The 4,000 daily visitors to his blog from around the world send him queries about stem cell treatments for a number of diseases ranging from arthritis to blindness. Knoepfler has inadvertently become a stem cell watchdog and authority on the clinical use of stem cell treatments. He offers a steadfast voice of caution on the use of unproven and illegal cell-based therapies.