CARLSBAD, Calif., March. 14, 2011 /PRNewswire/ — Life
Technologies Corporation (Nasdaq:
LIFE) today announced it has received FDA 510(k) clearance for
StemPro® MSC SFM – a first for this next-generation
stem cell culture medium that is now cleared as a medical device
and satisfies a crucial requirement for researchers involved in
clinical trials in the United States.
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The StemPro MSC SFM is a liquid medium intended for human ex
vivo (outside the body) tissue and cell culture – meaning it
is designed to efficiently grow large amounts of human mesenchymal
stem cells (MSCs) while maintaining their undifferentiated state.
As an FDA-cleared device, StemPro MSC SFM can potentially
expedite the regulatory review process associated with
investigational medical studies because it allows the reviewers to
focus on the science rather than the manner in which the cells are
grown.
“Anytime a research-related tool receives prior clearance from
the FDA it has the potential to accelerate the field’s move to the
clinic and that is CIRM’s goal, so this clearance is good news for
our mission and good news for patients,” said Alan Trounson,
President of the California Institute for
Regenerative Medicine, the state stem cell agency created by
Proposition 71.
Research and clinical trials have shown that MSCs have the
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