Dubious Stem Cell Creations

We’ve no doubt that this is how Captain Trips came about…

Food and Drug Administration just put dubious stem cell clinics on notice.

The agency announced plans on Monday for new policies and enforcement efforts to stamp out what it called “unscrupulous actors” peddling unproven, potentially dangerous, and often expensive stem cell therapies—including a bizarre and troubling instance involving smallpox vaccine.

As an initial demonstration of its harder stance, the agency today posted information on two enforcement efforts. One was a warning letter to a Florida stem cell clinic that had posed as legitimate clinical research andended up blinding three patients after injecting stem cells directly into their eyeballs. The other was a concerning announcement that the agency had seized five vials of smallpox vaccine from stem cell clinics in California.

The clinics, run by StemImmune Inc., were said to be mixing the dangerous vaccine with stem cells for an unproven, unapproved, and potentially harmful cancer treatment that was injected intravenously into patients or directly into their tumors. Though the injection of stem cells alone lacks safety and efficacy data, the vaccine is known to be dangerous. The vaccine contains a live poxvirus, similar but less harmful than smallpox. When it’s injected into patients with weakened immune systems—such as many cancer patients—the vaccine can cause life-threatening side effects, such as swelling of the heart.

Dubious Stem Cell Creations

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