FDA grants 510K clearance to Life Technologies
Life Technologies said it has received FDA 510K clearance for StemProR 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 U.S.
The StemPro MSC SFM is a liquid medium intended for human ex vivo tissue and cell culture. 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.
Currently there are several MSC experimental treatments in phase II and III IND clinical trials evaluating potential therapies, including: repairing heart tissue following a heart attack; a means to protect pancreatic islet cells in patients with Type I diabetes; and repairing lung tissue in patients with chronic obstructive pulmonary disease. MSCs' immunosuppressant capabilities are also being investigated as a potential treatment for Crohn's disease, an autoimmune condition, and neurological disorders resulting from stroke.
StemPro MSC SFM is the first product of its kind to receive clearance by the FDA.