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FDA Grants LIFE 510(k) Clearance for MSCs Medium

The FDA has granted 510(k) clearance for Life Technologies’ (NASDAQ: LIFE) StemPro® MSC SFM culture medium for the ex vivo tissue and cell culture of human mesenchymal stem cells (MSCs).
  • 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.

LIFEs clearance for clinical applications means there will be one less hurdle for the development of potential cell therapies based on MSCs.

  • Traditional serum-rich media, which has been widely used by researchers to grow MCSs in the laboratory, is supplemented with non-human origin components such as fetal bovine serum (FBS) and other growth factors that are not fully defined;
  • The ill-defined nature of serum-based media is undesirable for downstream research and therapeutic applications and puts a heavier burden on clinical researchers who must provide verifiable data on all the components used in their study.  

The Bottom Line: Research and clinical trials have shown that MSCs have the potential to play a critical role in the study of regenerative medicine.  Harvested from bone marrow, these multipotent cells were at the center of the world’s first tissue-engineered organ transplant in 2008 when surgeons in Spain successfully reconstructed a patient’s windpipe from her own stem cells.  A key component for stem cell research to advance into clinical trials and beyond is the ability to put validated tools into the hands of researchers. Currently there are several MSC experimental treatments in phase 2 and 3 Investigational New Drug (NYSE:IND) clinical trials.  These trials are 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.  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.