Dangerous Vaccines Seized from a California Stem Cell clinic

Courtesy Photo

Courtesy Photo

A dangerous unapproved smallpox vaccine was seized by Federal agents on Monday, amid a major crackdown on America's stem cell clinics.   The drug, which is not commercially available, is only allowed in special circumstances for high-risk groups.

On Monday, US Marshals Service found 5 vials of the small pox vaccine; which could potentially make enough for 500 people. The vials were found in StemImmune Inc, a San Diego, California Clinic.  One of the five vials have already been used.

The center was mixing the vaccine with stem cells from a patient in order to create an experimental cancer treatment, that they would inject into the patient's tumor.  

StemImmune Inc, is one of many clinics that have been opening across the United States, which claims to treat an array of different conditions raging from ALS to a low libido.  Regulators have vowed to shut these clinics down. 

"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," said the FDA on Monday.

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

Some types of stem cell transplants, that use mainly blood and skin stem cells, have been approved by health regulators.  This is after clinical trials found they could treat certain types of cancer and grow skin grafts for burn victims.  However, other potential therapies are still in the early stages of development.  And are often advertise with a false promise of a cure.  These kinds of therapies have little to no evidence proving that they are safe and that they actually work. 

"We are taken steps to tackle the problem of some 'troubling products' being marketed in Florida and California," the FDA said in a statement.

There are other clinics like StemImmune Inc that have received warning letters from the FDA for marketing stem cell research products without regulatory approval, and for major deviations from current good manufacturing practices. 

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