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. (http://bit.ly/2iB4Xls)
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.
Federal officials on Friday seized from San Diego-based StemImmune
Inc vials containing hundreds of doses of a vaccine reserved only
for people at high risk for smallpox, the FDA said. (http://bit.ly/2wC1DMU)
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The seizure followed recent FDA inspections that confirmed the
vaccine was used to create an unapproved stem cell product, which
was then given to cancer patients, the agency added.
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.
(Reporting by Natalie Grover in Bengaluru; Additional reporting by
Tamara Mathias; Editing by Sai Sachin Ravikumar)
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