Potential for Adult Stem Cells to Repair Hearts Damaged by Severe Coronary Artery Disease Investigated by Rush Cardiologists

February 02, 2007

CHICAGO-Rush University Medical Center is one of the first medical centers in the country, and currently the only site in Illinois, participating in a novel clinical trial to determine if a subject's own stem cells can treat a form of severe coronary artery disease.

The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial is the first human, Phase II adult stem cell therapy study in the U.S. designed to investigate the efficacy, tolerability, and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in subjects with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.

"What we're hoping is that these stem cells will be able to stimulate the growth of new blood vessels to bring more blood and oxygen to the heart muscle, so that these patients will have a better quality of life and less chest pain," said Dr. Gary Schaer, director of the Rush Cardiac Catheterization Lab and study investigator.

Myocardial ischemia is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart. The disease affects hundreds of thousands of new people each year. A person who suffers from chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.

The study is a randomized, double-blind, placebo-controlled study that involves adult subjects with severe coronary artery disease who are currently on the maximum medical therapy and who are not suitable candidates for conventional procedures to improve blood flow to the heart such as angioplasty, stents, or coronary artery bypass surgery.

Rush is one of 15 to 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation. Baxter technology is used to select the subject's own CD34+ stem cells that are under investigation in this trial.

The baseline frequency and severity of anginal episodes are established as a first step for all study subjects. Next, all subjects receive a series of subcutaneous injections (needle shots, typically delivered under the skin in the arm, thigh or abdomen) of a commercially produced protein (granulocyte colony stimulating factor). The protein helps to release CD34+ stem cells (also known as endothelial progenitor cells) from a subject's bone marrow into the bloodstream.

Then, investigators use a cell separation system, similar to the automated systems that are used with people who donate specific blood components such as platelets or red blood cells, to collect from the subject's bloodstream, an enriched preparation of cells that contain CD34+ stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System, currently approved for use with cancer patients, to select the subject's CD34+ stem cells for use in this investigational therapy.

Schaer then uses a catheter-based, non-surgical system to map the patient's heart three-dimensionally to identify the damaged areas into which the stem cells would be injected. "This targeted approach increases the treatment's effectiveness by delivering the stem cells exactly where they are needed." Schaer uses the Johnson & Johnson's NOGA XP Cardiac Navigation System to identify ischemic but viable regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter that functions like a "global positioning system" to precisely deliver CD34+ cells, or placebo, into the areas of the heart that have been identified as having poor blood flow.

Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Rush researchers will conduct follow-up examinations for 12 months,

Researchers are encouraged by reports that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy in an earlier study. According to preliminary, anecdotal patient reports, 16 of the 24 total Phase I study subjects reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial.

Rush University Medical Center

---

---

	Essentials of Stem Cell Biology, Second Edition by Robert Lanza (Editor), John Gearhart (Editor), Brigid Hogan (Editor), Douglas Melton (Editor), Roger Pederson (Editor), E. Donnall Thomas (Editor), James Thomson (Editor), Sir Ian Wilmut (Editor) First developed as an accessible abridgement of the successful Handbook of Stem Cells, Essentials of Stem Cell Biology serves the needs of the evolving population of scientists, researchers, practitioners and students that are embracing the latest advances in stem cells. Representing the combined effort of seven editors and more than 200 scholars and scientists whose pioneering work has defined our understanding of stem cells, this book combines the prerequisites for a general understanding of adult and embryonic stem cells with a presentation by the world's experts of the latest research information about specific organ systems. From basic biology/mechanisms, early development, ectoderm, mesoderm, endoderm, methods to application of stem cells to specific human diseases, regulation and...
	The Stem Cell Hope: How Stem Cell Medicine Can Change Our Lives by Alice Park (Author) A landmark book by the senior science writer at Time magazine introduces us to a medical breakthrough that can save our lives. Few people know much about stem cell research beyond the ethical questions raised by using embryos. But in the last decade, stem cell research has made huge advances toward eliminating some of our most intractable diseases. Now this sweeping and accessible book introduces us to this cutting-edge science that will revolutionize medicine and change the way we think about and treat disease. Alice Park takes us from stem cell's controversial beginnings to the recent electrifying promise of being able to create the versatile cells without using embryos at all. She shows us how stem cells give researchers an unprecedented ability to study disease while...
	Stem Cells For Dummies by Lawrence S.B. Goldstein (Author), Meg Schneider (Author) The first authoritative yet accessible guide to this controversial topicStem Cell Research For Dummies offers a balanced, plain-English look at this politically charged topic, cutting away the hype and presenting the facts clearly for you, free from debate. It explains what stem cells are and what they do, the legalities of harvesting them and using them in research, the latest research findings from the U.S. and abroad, and the prospects for medical stem cell therapies in the short and long term.Explains the differences between adult stem cells and embryonic/umbilical cord stem cellsProvides both sides of the political debate and the pros and cons of each side's opinionsIncludes medical success stories using stem cell therapy and its promise for the futureComprehensive and unbiased, Stem...
	Human Stem Cell Technology and Biology: A Research Guide and Laboratory Manual by Gary S. Stein (Editor), Maria Borowski (Editor), Mai X. Luong (Editor), Meng-Jiao Shi (Editor), Kelly P. Smith (Editor), Priscilla Vazquez (Editor) Human Stem Cell Technology & Biology: A Research Guide and Laboratory Manual integrates readily accessible text, electronic and video components with the aim of effectively communicating the critical information needed to understand and culture human embryonic stem cells.Key Features:An authoritative, comprehensive, multimedia training manual for stem cell researchersEasy to follow step-by-step laboratory protocols and instructional videos provide a valuable resourceA must-have for developing laboratory course curriculums, training courses, and workshops in stem cell biologyPerspectives written by the world leaders in the fieldIntroductory chapters will provide background informationThe volume will be a valuable reference resource for both experienced investigators pursuing stem cell and...
	Stem Cell Now by Christopher Thomas Scott (Author) While many believe stem cell research holds the key to curing a wide range of ailments, others see this research as opening a Pandora’s box that will devalue human life. In Stem Cell Now, Christopher Scott—executive director of Stanford University’s Stem Cells and Society Program—lays out the scientific and ethical issues surrounding this national dilemma. Scott guides readers through the latest advances in stem cell research in clear, accessible language, telling the stories of the researchers who are exploring the potential of stem cells to cure cancer, grow new organs, and repair the immune system. He also leads readers through a discussion of the question at the heart of the explosive ethical debate: How, as a society, do we balance our responsibilities to the unborn and the...
	Essential Stem Cell Methods (Reliable Lab Solutions) by Robert Lanza (Editor), Irina Klimanskaya (Editor) As part of the Reliable Lab Solutions series, this volume offers an abridged and comprehensive update of selected chapters that first appeared in the three-volume stem cell series published in Methods in Enzymology. Currently, stem cells are of great interest to scientists and clinicians due to their unique ability to differentiate into various tissues of the body, making them a promising source of cells for regenerative medicine and drug discovery as well as an excellent model of vertebrate development. Essential Stem Cell Methods features a detailed set of protocols written by experts in the field and hand-selected by the editors to help researchers drive advances in this fast-moving field. The result is a clear set of step-by-step methods which steer the reader through the...
	Stem Cells: Scientific Facts and Fiction by Christine Mummery (Author), Ian Sir Wilmut (Author), Anja Van De Stolpe (Author), Bernard Roelen (Author) In the past decades our understanding of stem cell biology has increased tremendously. Many types of stem cells have been discovered in tissues of which everyone presumed were unable to regenerate in adults; these include particularly the heart and the brain. There is vast interest in stem cells from biologists and clinicians who see the potential for regenerative medicine and future treatments for chronic diseases like Parkinson, diabetes and spinal cord lesions based on the use of stem cells and entrepreneurs in biotechnology who expect new commercial applications ranging from drug discovery to transplantation therapies. As is often the case in science, many early claims turned out to be different from those expected. Embryonic stem cell therapies have not moved rapidly into clinical...
	The Stem Cell Theory of Renewal: Demystifying the Most Dramatic Scientific Breakthrough of Our Time by Christian Drapeau (Author) Are the functions of Adult Stem Cells really the most dramatic scientific breakthrough of our times? Visionary Stem Cell Scientist and Stem Cell Nutrition expert Christian Drapeau says 'Absolutely Yes' as he explains the science and implications behind the body's natural renewal system. Adult Stem Cells in your bone marrow constitute the natural healing system of your body. Wherever there is an injury or damage to any organ, stem cells are released from the bone marrow. They migrate to that organ and become healthy cells of that organ, literally repairing the damaged tissue. The implications of new developments in Adult Stem Cell science for health and wellness are mind boggling.
	Stem Cells: A Very Short Introduction by Jonathan Slack (Author) Embryonic stem cells have been hot-button topics in recent years, generating intense public interest as well as much confusion and misinformation. In this Very Short Introduction, leading authority Jonathan Slack offers a clear and informative overview of stem cells--what they are, what scientists do with them, what stem cell therapies are available today, and how they might be used in the future. Slack explains the difference between embryonic stem cells, which exist only in laboratory cultures, and tissue-specific stem cells, which exist in our bodies, and he discusses how embryonic stem cells may be used in the future to treat such illnesses as diabetes, Parkinson's disease, heart disease, spinal trauma, and retinal degeneration. But he stresses that, despite important advances, the...
	Stem Cell Wars: Inside Stories from the Frontlines by Eve Herold (Author), George Daley (Foreword) Americans have become the victims of misinformation about stem cell research. Over the last few years, the stem cell debate has been intensely political, religious, and confusing to many people. Now, Eve Herold explains what this science is all about, who is for and against it, and why it must go forward. She pulls together fascinating stories to highlight every aspect of this multifaceted field. She exposes the politics of stem cell research and demonstrates how the outcome of the debate could ultimately affect all of us. Packed with real-life stories of the people caught up in this groundbreaking struggle, Stem Cell Wars cuts through the noise and sets the standard for future debate.