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FDA Grants 510(k) Clearance to Life Technologies Stem Cell Growth Medium
Date:3/14/2011

tential 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, as reported by the BBC.  Several of Life Technologies' cell culture media were used in the process to grow and culture that patient's stem cells.  The stem cells were then washed prior to implantation to remove trace amounts of media.

Currently there are several MSC experimental treatments in phase 2 and 3 Investigational New Drug (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.

StemPro MSC SFM is the first and only product of its kind to receive clearance by the FDA.  It was introduced on the market in May 2009 as a serum-free medium (SFM) for research-use-only and marked the next step in this technology over serum-enriched media.

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
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SOURCE Life Technologies Corporation
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