Wednesday, January 20, 2016

Unregulated Stem Cell Clinics in the U.S. Draw Criticism from the FDA

According to The New England Journal of Medicine, stem-cell-based medicine has transformed the medical and cosmetic industries across the United States, as more and more doctors offer stem-cell procedures for everything from arthritis and multiple sclerosis to facelifts and other anti-aging treatments. Additionally, hundreds of stem-cell clinics have launched throughout the U.S. in an effort to capitalize on the still uncertain effects of so-called regenerative medicine. In fact, the Food and Drug Administration (FDA) has only approved a small number of stem-cell-based therapies for blood and immune system diseases. So, what should the public think when it comes to the ever-increasing number of stem-cell treatments now available on the market?

What many of these clinics mean by stem-cell therapy is a product called stromal vascular fraction (SVF), which is essentially a collection of cells taken from a patient’s own fat tissue that is then administered back into specific areas of the patient’s body to stimulate healthy tissue growth and immune system function. The SVF therapies are sold as potential treatments for a wide range of health conditions such as hair loss, wrinkles, and even muscular dystrophy.

While stem cells have been recognized for their ability to trigger the body’s natural cell replacement and tissue repair, the FDA has taken action in recent years to prevent stem-cell clinics from offering treatments that it hasn’t yet approved for public use. However, cutting edge procedures, such as those involving stem cells, continue to evolve and improve, and should not be arbitrarily restricted by the FDA or other agencies. Stem cell procedures, like all invasive medical procedures, should be performed by appropriately licensed, board-certified physicians with specialized training and expertise.

Physicians that provide stem cell and other experimental treatments should act in an ethical manner and put patient welfare above profit. When considering stem cell therapy, ethical physician providers should obtain informed consent after adequately educating and counseling patients, and if the decision is made to proceed, providers should implement reasonable and sufficient measures to maximize patient safety.

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