U.S. FDA strengthens oversight of stem cell therapies

Source: Xinhua| 2017-08-29 04:34:16|Editor: yan
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WASHINGTON, Aug. 28 (Xinhua) -- The U.S. Food and Drug Administration (FDA) said on Monday that it's strengthening oversight of an emerging field of medicine called stem cell therapies in an effort to eliminate "bad actors."

"These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity's most troubling and intractable maladies," FDA Commissioner Scott Gottlieb said in a statement.

However, a small number of "unscrupulous actors" seized on that promise and made "deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products," putting the entire field at risk, Gottlieb said.

In the last few days alone, the FDA has taken steps in Florida and California to address several "especially troubling" stem cell products being marketed, he said.

On Friday, federal officials seized five vials of smallpox vaccine from a San Diego clinic that combined it with stem cells to create an unapproved product to treat cancer patients, without any proof that it worked, the FDA said.

The U.S. agency also issued a warning letter to Florida-based U.S. Stem Cell Clinic for marketing unapproved stem cell products and for "significant deviations" from current good manufacturing practice requirements.

A recent FDA inspection of the clinic found that it was using stem cells derived from body fat to treat a variety of serious diseases or conditions, including Parkinson's disease and heart disease, without any regulatory review or approval, it said.

The FDA will release a new policy framework this fall that will "more clearly describe the rules of the road for this new field," Gottlieb said.

For example, some stem cell therapies in which cells or tissues are taken from and given back to the same individual without significant manufacturing to perform the same basic functions may not require FDA premarket review, he said.

However, when significant manufacturing is performed on the cells or tissues, or when the cells or tissues are not intended to perform the same basic functions, premarket review is required.

"We must put in place the framework to separate the promising treatments from those products that pose significant risks or offer patients little to no chance of benefit," said Gottlieb.

"We can't let a small number of unscrupulous actors poison the well for the good science that holds the promise of changing the contours of human illness and altering the trajectory of medicine and science."

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