Adult stem cells that have been derived from human adipose (fat) tissue mark the first of their kind in a new breakthrough that could offer an ideal stem cell therapy for heart patients.

According to Dr. Rodney Dilley, principal scientist at Melbourne’s Bernard O’Brien Institute, “The fact that you can do this potentially opens a whole area of heart regeneration methods. Our approach is to create a piece of heart muscle that we can use to put onto the heart to stop it from remodelling and to return its contractile function to normal.” Since heart muscle does not usually regenerate itself after injury, but instead forms scar tissue as part of the “remodelling” process, this announcement by the Australian scientists has far-reaching implications for the field of cardiology. Additionally, since most people have accumulated the storage of some body fat, adipose tissue constitutes one of the most easily accessible sources of autologous adult stem cells.

The discovery could potentially offer a treatment for a wide variety of cardiac problems, ranging from congenital heart defects to age-related heart disease.

As a medical therapy, stem cells offer, for the first time in history, the possibility of treatment and perhaps even the cure of human diseases which previously have been untreatable. Precisely for that reason, the business of stem cells is projected to be a lucrative one.

The stem cell field is estimated to become a $500 billion industry over the next 20 years, and there is hardly a nation on earth that is not targeting stem cell research and development as part of its economy. To be able to “get in at the ground floor”, in any business with this potential for growth, is a rare opportunity. Recognizing such an obvious fact, the largest pharmaceutical company in the world has now decided to seize this opportunity.

According to Dr. John McNeish, executive director of R&D at Pfizer, the pharmaceutical industry leader is scheduled to open its second regenerative medicine center in Cambridge, England, next month. The focus of its U.K. location will be iPS (induced pluripotent stem) cells and their applications in ophthalmologic and central nervous system diseases. Pfizer’s first regenerative medicine center, located in Cambridge, Massachusetts, already focuses on stem cell therapies for the treatment of heart disease and diabetes.

As Dr. McNeish announced to reporters last month at the World Stem Cell Summit that was held in Madison, Wisconsin, “Stem cells can help us make good decisions about which compounds will be more likely to be safe. These cells will be tremendous in drug discovery. They will help us understand personalized medicine, genetic variation, ethnic populations, and which biomarkers to follow.”

As the largest pharmaceutical company in the world, Pfizer employs approximately 100,000 people worldwide in the manufacture and commercialization of prescription medication, with sales of Lipitor, its cholesterol-lowering drug, exceeding $10 billion last year alone. As an indication of its commitment to the stem cell field, Pfizer’s new regenerative medicine center in Cambridge, England, is estimated to occupy a space of approximately 52,000 square feet in area.

Pfizer is not the first pharmaceutical company to enter the stem cell industry. Last year, GlaxoSmithKline (GSK), AstraZeneca and Roche Holding together launched a new drug screening initiative entitled “Stem Cells for Safer Medicines”. GSK has also announced a $25 million collaboration with the Harvard Stem Cell Institute, geared toward developing the drug screening potential of stem cell technology.

The merging of “big pharma” with stem cell R&D is perhaps the latest and most significant indication of the rapid growth of the stem cell field, though this will certainly not be the last indication of its type.

In January of 2008, Osiris Therapeutics and Genzyme began collaborating together on a multi-million-dollar Department of Defense (DoD) contract that was awarded to Osiris, the objective of which is the development of a civilian and military medical response to nuclear or radiological events.

The DoD contract specifies the development and stockpiling of Prochymal, which is a proprietary adult stem cell therapy developed by Osiris, specifically for the repair of cellular injury that might result from the “acute radiation syndrome” (ARS) that accompanies severe and sudden radiation exposure. Terms of the contract provide for the purchase of up to 20,000 doses of Prochymal by the DoD at $10,000 per dose.

According to C. Randal Mills, Ph.D., President and CEO of Osiris, “We are honored that the Department of Defense has selected Prochymal in this critical effort to better safeguard our armed forces against the potentially horrendous effects of battlefield exposure to a radiological weapon. The contract also brings into focus a substantial new market opportunity for Prochymal. We are working diligently towards licensure of Prochymal for ARS and stand ready to assist other sectors of the United States government and allied nations in their emergency preparedness efforts.”

Major General John Parker, M.D., a former Commanding General who is currently responsible for countermeasure development and acquisition and who is also a member of the Medical Countermeasure Advisory Board of Osiris, adds, “Prochymal’s unique mechanism of action and strong clinical profile make it very well suited to address the complicated injuries associated with ARS. Currently, every scenario contemplating a radiological emergency, both civilian and military, involves people suffering from the life-threatening effects of ARS without effective treatments. Today’s decision by DoD sets in motion a sound plan to change that, by expeditiously completing development of the first effective therapy for ARS.”

As Henri Termeer, Chairman and CEO of Genzyme, explains, “We are pleased to partner with Osiris in developing this innovative cell therapy to treat the potentially lethal complications of ARS for the U.S. military. With our combined first-in-class technology and development expertise, Osiris and Genzyme have the necessary resources to complete this assignment for the Department of Defense and to work with other government organizations committed to safeguarding our nation and its allies.” According to Thomas MacVittie, Ph.D., Professor of Radiation Oncology and Pathology at the University of Maryland and a member of the NIAID (National Institute of Allergy and Infectious Diseases) Medical Countermeasures and CDC Strategic National Stockpile Radiation Working Groups, who is also a member of the Medical Countermeasure Advisory Board of Osiris, “Prochymal represents a breakthrough in countermeasure development for ARS. Prochymal has demonstrated therapeutic utility in humans repairing many of the major organ systems affected by radiation injury. Where most approaches only target a single component of ARS, Prochymal has the potential to address the entire syndrome including both acute and delayed effects in multiple organ systems.”

ARS is known to damage most severely the DNA of the rapidly dividing cells in the gastrointestinal tract, the skin and bone marrow. If severe and untreated, death can result within a matter of days or months following the initial exposure. Prochymal is a highly purified formulation of mesenchymal stem cells that are cultured and expanded. Prochymal is currently in Phase II clinical trials for the treatment of Type I diabetes, and Phase III clinical trials for both the treatment of Graft vs. Host Disease and Crohn’s disease. Additionally, Prochymal has demonstrated preliminary efficacy in the treatment of heart attacks and it has demonstrated a strong safety profile in seven previous Phase I and Phase II clinical trials. Prochymal has also shown a potential ability to reverse cellular damage and improve survival in diseases that are similar to ARS.

While warfare has always been understood to have biological and health consequences for those who are involved, the anti-inflammatory and regenerative properties of adult stem cells now offer a new type of countermeasure against nuclear and radiological threats. The strong interest of the Deparment of Defense in adult stem cell therapies marks yet another historic milestone in the versatility and applicability of these potent therapies.

The ThermoGenesis Corporation, which manufactures automated blood processing systems and disposable products that are used in the manufacture, preservation and delivery of cell and tissue therapy products, including the processing and storage of adult stem cells, announced today that it has received FDA authorization to begin marketing its MarrowXpress (MXP) device. The MXP is used for the preparation of the adult stem cell concentrate that is derived from bone marrow, and as such the device is applicable both in intraoperative and clinical laboratory settings.

In June, ThermoGenesis submitted a pre-market notification application to the FDA, which subsequently determined that the MXP is exempt from pre-market notification requirements and instead will be subject to regulation that governs laboratory equipment which is designated for specific medical utilization. According to Dr. William Osgood, CEO of ThermoGenesis, “This notification that we can immediately begin marketing our MXP device is a major regulatory milestone for the company and particularly exciting since we received this notification just several weeks after filing our submission, and since it follows by less than a month from having received the CE-Mark enabling us to market the device in the European Community. In anticipation of this authorization, we have initiated discussions with an orthopedic surgery group, vascular surgeons, and leading academic medical centers not only in the U.S. but also in Europe and Asia, and we look forward to begin placing this device in the clinical setting in the near future. We believe this positions ThermoGenesis to significantly participate in what will ultimatel represent a multi-billion dollar market opportunity in regenerative medicine.”

Bone marrow is the leading source for adult stem cells that are currently in clinical trials for the treatment of a variety of diseases which include, most predominantly, ischemic heart disease, peripheral artery disease, diabetes and blood disorders. According to the U.S. Centers for Disease Control and Prevention, approximately 24 million people in the U.S. alone are known to have heart disease, while approximately 16.2 million people have peripheral artery disease and another 15.8 million people suffer with diabetes. Such statistics for the U.S. comprise nearly half of all documented cases of these diseases worldwide. While the MXP is specifically designed for the processing of stem cells from bone marrow, similar technologies are also being developed with applications to adult stem cells that are derivable from blood and fat.

According to Dr. John Chapman, Vice President of Research and Development and Scientific Affiars at ThermoGenesis, “We are confident that the users of this technology will value the unique capability of this device to achieve significantly improved recovery of the stem cells from bone marrow, meaning that less marrow will need to be collected from their patients to obtain the same number of stem cells. While the initial marketing application for the MXP will be for bone marrow processing, both at point-of-care and in a laboratory, we will continue our exploration of the use of this technology platform for other sources of adult stem cells including mobilized peripheral blood and adipose tissue stem cell processing.”

This latest FDA authorization of a newly patented medical device represents merely one more example of the explosive growth that is occurring in the regenerative medicine industry, not only in regard to the biological materials themselves, such as the stem cells, that are used, but also in regard to the electronic machinery and engineering that are helping to drive the medical advancements, and for which there is also an increasing global market.