December 1, 2020

The Niche

Knoepfler lab stem cell blog

A trifecta of wins against stem cell tourism: 60 Minutes, FDA, and China

In a matter of just a few days we saw three big positive moves against stem cell tourism that will no doubt make a big difference even if there is a long slog ahead against dubious stem cell clinics trying to exploit patients.

First, we had the 60 Minutes broadcast on Sunday containing a segment against stem cell quackery that was very high impact, watched by millions of people and talked about by millions more.

Second, the FDA formally issued an educational warning statement to patients about illegal stem cell treatments. You can read the statement here. Very cool!  Here’s the FDA’s advice to patients in bullet points.

Advice for Consumers

  • 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.“There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body,” says Simek. Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else.
  • 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.

Third and a very pleasant surprise was China taking a bold step against stem cell tourism in that country by halting all non-approved stem cells treatments. I applaud this action by the leaders in China. It was very bold and will protect countless thousands of people. I also view this as a major step for China in its goal of becoming a global leader in stem cell research and regenerative medicine. I will write more on China and stem cells in a future post, but I do see them becoming a leader in stem cells.

Make no mistake, we have a long road ahead against stem cell tourism, but these three developments give more reason for hope.