Life Technologies Stem Cell Growth Medium Receives FDA 510(k) Clearance as Medical Device
Posted Mar 14 2011 2:30pm
If you have not heard of Life Technologies, they are involved in a lot of different areas. Recently they made the news with the desktop Ion Torrent sequencing machine. Will a sequencing machine sit next to a desktop printer in the future? StemPro is a serum-free medium (SFM) for research-use and is the next step in this technology over serum-enriched media. This is also a move away from using animal based products for growing stem cells.
In addition the company was one of the participants involved in helping sequence Ozzy too, and we all waited to hear those results as curiosity as to what types of “tough” genes he has was on everyone’s mind.
The focus on this FDA approval is a bit technical to understand but in short it’s a process for stem cell technology to be used to find new potential treatments for Crohn’s disease, multiple sclerosis and heart disease. If you want to dig in a little further the video has an employee talk about what they are doing with DNA and what his part is in the scheme of their research and development. BD
From the Life Technologies website:
“Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology tools company dedicated to improving the human condition.
Our systems, consumables and services enable researchers to accelerate scientific exploration, driving to discoveries and developments that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance personalized medicine, regenerative science, molecular diagnostics, agricultural and environmental research, and 21st century forensics.
Life Technologies had sales of more than $3.3 billion in 2009, employs approximately 9,000 people, has a presence in 160 countries, and possesses a rapidly growing intellectual property estate of approximately 3,900 patents and exclusive licenses.
Life Technologies was created by the combination of Invitrogen Corporation and Applied Biosystems Inc in November of 2008.”
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.
StemPro MSC SFM complements Life Technologies' full range of Cell Therapy Systems (CTS™) products, which are used by investigators in their stem cell research for ex vivo tissue and cell culture applications and have previously received 510(k) clearance by the FDA. They include: AIM V® Medium , DMEM , KnockOut™ SR Medium and KnockOut™ SR XenoFree Medium. The company's portfolio of solutions addresses the entire stem cell continuum, including the isolation, expansion, differentiation and characterization of cells.