FDA seizes dangerous unapproved vaccine

Federal agents have seized a dangerous unapproved smallpox vaccine from one of America’s many stem cell clinics, amid a major crackdown on the ‘unscrupulous’ centers.

The drug, only allowed in special circumstances for high-risk groups, is not commercially available.

However, on Monday, the US Marshals Service found five vials of the product – enough for 500 vaccines – in StemImmune Inc, a clinic in San Diego, California. Four of the vials were unopened but one had been used. 

They found the center was mixing the vaccine with stem cells from a patient to create an experimental cancer treatment, which they injected into the patient’s tumor.  

The clinic is one of hundreds popping up across the United States, which claim to treat anything from ALS to a low libido – which regulators have vowed to shut down. 

The US Marshals Service found five vials of the product – enough for 500 vaccines – in StemImmune Inc, a clinic in San Diego, California, on Monday (file image)

There has been a huge increase in the number of clinics practicing experimental stem cell treatments in the past few years. The emerging field of medicine that holds significant promise for curing some of the most troubling diseases by using the body’s own cells.

A small number of ‘unscrupulous actors’ have seized on the promise of regenerative medicine and stem cell therapies to mislead patients based on unproven, and in some cases, dangerously dubious products, the FDA said on Monday. 

Regenerative medicine makes use of human cells or tissues that are engineered or taken from donors. 

Health regulators have approved some types of stem cell transplants – that mainly use blood and skin stem cells – after clinical trials found they could treat certain types of cancer and grow skin grafts for burn victims.

But many potential therapies are still in the earliest stages of development. These therapies are sometimes advertised with the promise of a cure, but they often have scant evidence backing their efficacy or safety.

The FDA said it had taken steps to tackle the problem of some ‘troubling products’ being marketed in Florida and California.

Aside from the raid on StemImmune Inc, the FDA also sent a warning letter to a Sunrise, Florida-based clinic for marketing stem cell products without regulatory approval and for major deviations from current good manufacturing practices.

The health regulator will present a new policy framework this fall that will more clearly detail the ‘rules of the road’ for regenerative medicine, FDA Commissioner Scott Gottlieb, a cancer survivor, said in a statement.

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