FDA Grants 510(k) Clearance to Life Technologies Stem Cell Growth Medium
http://www.prnewswire.com/news-releases/fda-grants-510k-clearance-to-life-technologies-stem-cell-growth-medium-117920569.html
- A first for this type of product to enable clinical research
- Facilitates regulatory review process for regenerative medicine studies
- Developed for cell type currently in clinical trials investigating potential treatments for Crohn's disease, multiple sclerosis and cardiovascular disease
CARLSBAD, Calif., March. 14, 2011 /PRNewswire/ -- 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."
About Life Technologies (www.lifetechnologies.com)
Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific and medical advancements that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance the fields of discovery and translational research, molecular medicine, stem cell-based therapies, food safety and animal health, and 21st century forensics. The company manufactures both molecular diagnostic and research use only products. Life Technologies' industry-leading brands are found in nearly every life sciences lab in the world and include innovative instrument systems under the Applied Biosystems and Ion Torrent names, as well as, the broadest range of reagents with its Invitrogen, GIBCO, Ambion, Molecular Probes and Taqman products. Life Technologies had sales of $3.6 billion in 2010, has a workforce of approximately 11,000 people, has a presence in approximately 160 countries, and possesses one of the largest intellectual property estates in the life sciences industry, with approximately 3,900 patents and exclusive licenses. For more information on how we are making a difference, please visit our website: http://www.lifetechnologies.com.
Life Technologies' Safe Harbor Statement
This press release includes forward-looking statements about our anticipated results that involve risks and uncertainties. Some of the information contained in this press release, including, but not limited to, statements as to industry trends and Life Technologies' plans, objectives, expectations and strategy for its business, contains forward-looking statements that are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Any statements that are not statements of historical fact are forward-looking statements. When used, the words "believe," "plan," "intend," "anticipate," "target," "estimate," "expect" and the like, and/or future tense or conditional constructions ("will," "may," "could," "should," etc.), or similar expressions, identify certain of these forward-looking statements. Important factors which could cause actual results to differ materially from those in the forward-looking statements are detailed in filings made by Life Technologies with the Securities and Exchange Commission. Life Technologies undertakes no obligation to update or revise any such forward-looking statements to reflect subsequent events or circumstances.
Life Technologies Contact
Mauricio Minotta
760-929-2456 (main)
760-805-5266 (mobile)
Mauricio.minotta@lifetech.com
http://www.prnewswire.com/news-releases/fda-grants-510k-clearance-to-life-technologies-stem-cell-growth-medium-117920569.html
- A first for this type of product to enable clinical research
- Facilitates regulatory review process for regenerative medicine studies
- Developed for cell type currently in clinical trials investigating potential treatments for Crohn's disease, multiple sclerosis and cardiovascular disease
CARLSBAD, Calif., March. 14, 2011 /PRNewswire/ -- 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."
About Life Technologies (www.lifetechnologies.com)
Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific and medical advancements that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance the fields of discovery and translational research, molecular medicine, stem cell-based therapies, food safety and animal health, and 21st century forensics. The company manufactures both molecular diagnostic and research use only products. Life Technologies' industry-leading brands are found in nearly every life sciences lab in the world and include innovative instrument systems under the Applied Biosystems and Ion Torrent names, as well as, the broadest range of reagents with its Invitrogen, GIBCO, Ambion, Molecular Probes and Taqman products. Life Technologies had sales of $3.6 billion in 2010, has a workforce of approximately 11,000 people, has a presence in approximately 160 countries, and possesses one of the largest intellectual property estates in the life sciences industry, with approximately 3,900 patents and exclusive licenses. For more information on how we are making a difference, please visit our website: http://www.lifetechnologies.com.
Life Technologies' Safe Harbor Statement
This press release includes forward-looking statements about our anticipated results that involve risks and uncertainties. Some of the information contained in this press release, including, but not limited to, statements as to industry trends and Life Technologies' plans, objectives, expectations and strategy for its business, contains forward-looking statements that are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Any statements that are not statements of historical fact are forward-looking statements. When used, the words "believe," "plan," "intend," "anticipate," "target," "estimate," "expect" and the like, and/or future tense or conditional constructions ("will," "may," "could," "should," etc.), or similar expressions, identify certain of these forward-looking statements. Important factors which could cause actual results to differ materially from those in the forward-looking statements are detailed in filings made by Life Technologies with the Securities and Exchange Commission. Life Technologies undertakes no obligation to update or revise any such forward-looking statements to reflect subsequent events or circumstances.
Life Technologies Contact
Mauricio Minotta
760-929-2456 (main)
760-805-5266 (mobile)
Mauricio.minotta@lifetech.com