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.
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 po