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.
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, 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-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.
"An FDA-cleared, serum-free medium certainly provides a positive step toward moving away from mostly animal-based products for growing mesenchymal stem cells," said Stanton L. Gerson, MD, Director, University Hospitals Seidman Cancer Center and the National Center for Regenerative Medicine, at Case Western Reserve University, a pioneer in the use of adult stem cells to treat cancer and heart disease who is also part of a team conducting early phase clinical trials with MSCs to treat graft-versus-host disease and multiple sclerosis. "Growth media that is better defined can facilitate regulatory requirements. Ultimately, clinical trials will determine whether it benefits patients."
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.
"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 who are working to make cell therapy a reality," says Joydeep Goswami, Head of Primary & Stem Cells at Life Technologies. "The 510(k) clearance by the FDA of our StemPro MSC SFM is a pivotal step in that direction, and reinforces Life Technologies' commitment to providing higher-quality and innovative solutions to our customers."
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