Over the past decade, there has been an explosion of international and domestic medical clinics that advertise unproven stem cell therapies for a wide range of diseases usually at a high cost to patients. This is often referred to as “Stem cell tourism.”
Unfortunately, these sites usually do not provide information on what type of stem cells are being offered and are not regulated by governmental agencies, instead relying on anecdotal evidence and patient testimonials to promote their product.
In the US, the Food and Drug Administration (FDA) regulates stem cells to ensure they are safe and effective for their intended use. They advise the following:
If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.
If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used solely in countries other than the United States and typically has little information about foreign establishments or their stem cell products.
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