Life Technologies has received FDA 510(k) clearance for StemPro MSC SFM - a first for this next-generation stem cell culture medium that is cleared as a medical device and satisfies a crucial requirement for researchers involved in clinical trials in the US.
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.
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 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.