Alliance for Regenerative Medicine - Disease SpotlightDisease Facts: Cardiovascular Disease (CVD)Description: + Multiple Approaches for Strengthening Weakened Hearts+ CVD is an umbrella term Cardiovascular disease (CVD), which created additional functioning heart of efficacy of this form of treatment.that encompasses a wide affects a person’s heart and muscle.range of medical issues, circulatory system, are highly Aldagen, a North Carolina-basedincluding hypertension, prevalent among the general Several Alliance members are company, has completed a Phase Istroke, heart attack, and population and represents the conducting clinical trials in CVD. trial in heart failure patients for leading causes of death and disability Specifically, ARM members are which the company’s cell therapycoronary heart disease in the U.S., leaving a substantial working on new therapies to address was shown to improve the move- impact on our national health care heart attack, ischemic heart failure, ment of blood in the heart andPatients: infrastructure. The most recent congestive heart failure, dilated improve patients’ clinical studies completed by the American cardiomyopathy and stroke (see the status. Aldagen is developing its+ Affects 36% of Heart Association (AHA) estimate ‘Stroke’ disease spotlight for more therapies from patient’s own boneAmericans in some form that 36% of Americans currently information): marrow using propriety technology+ Incidence projected to suffer from some form of CVD. This to isolate cells that are able to includes the 12% of Americans who Aastrom Biosciences, located inincrease to 40% by 2030 improve blood flow to ischemic experienced heart attack, congestive Michigan, is in a Phase II trial for an tissues. Aldagen is planning to heart failure, or stroke in 2010. While autologous (self-donated) stem cellCurrent Costs: commence Phase II trials for symptoms of these CVDs vary widely, therapy using cardiac repair cells ischemic heart failure — as well as+ $272 billion in direct survivors of the most acute (CRCs) to treat cardiomyopathy. This critical limb ischemia and stroke — incosts conditions often undergo life- condition causes the heart muscle to 2011. changing treatments ranging from deteriorate, leaving patients+ $171 billion in lost vulnerable to arrhythmia or sudden Athersys has developed MultiStem®, daily medications to surgicalproductivity interventions such as pace makers, death. Between 200,000 and an off-the-shelf stem cell therapy angioplasty, or heart transplants. 400,000 Americans are affected by using donated adult cells from bone Patients with heart disease, cardiomyopathy. The current marrow and other non-embryonicFrom the American Heart standard of treatment is limited to sources for targeted treatments of especially those who have survivedAssociation: acute events, often suffer from long- heart transplant or the use of multiple conditions, including heart“Cardiovascular disease term disabilities, loss of productivity, mechanical pumps, whereas attack, inflammatory bowel disease, and diminished quality of life. Aastrom’s approach of infusing and ischemic stroke. The Ohio-based(CVD) is the leading cause patients with CRCs is predicted to company recently completed a Phaseof death in the United CVD is generally progressive and help the body activate its own I trial for heart attack, which showedStates and is responsible often necessitates more significant healing mechanisms. that MultiStem® is safe and medical interventions over time, appeared to improve heart functionfor 17% of national health highlighting the need for innovative Advanced Cell Technology, with through several mechanisms. Theexpenditures. As the and effective treatments that can offices in Massachusetts and company is planning to initiate Phase repair damaged cardiac muscle and California, is approved by the FDA topopulation ages, these begin a Phase II study for congestive 2 studies in heart attack and stroke in revascularize obstructed veins and 2011.”costs are expected to arteries. Regenerative medicine heart failure (CHF). ACT’s productincrease substantially.” technologies could fill this need by candidate uses the patient’s own Cytori, located in California, markets - January 2011 using living cells as therapies to help myoblasts (adult muscle stem cells the Celution® System for extracting stimulate the growth of functional that can form muscle fibers) to repair and concentrating adipose (fat)- heart muscle. The most recent damaged heart muscle and promote derived stem and regenerative cells scientific evidence for this approach new blood vessels in the damaged (ADRCs) used in research and which came from the University of Miami, area. CHF is an end-stage CVD that may ultimately be used in various where a small human trial for heart leaves patients with few options forms of therapy. Cytori is also attack showed that patients infused other than heart transplant. By using sponsoring two clinical trials using The Alliance for with stem cells extracted from their a catheter delivery technique, ACT’s patient’s own ADRCs to treat acute Regenerative Medicine own bone marrow replaced scar approach potentially offers a safer heart attack and chronic myocardial tissue and reduced enlarged hearts (compared to the risks of transplant) ischemia, with the aim of reducing (ARM) was formed to by up to 25%. The stem cells fostered and more cost-effective treatment post-incident disability and mortality advance regenerative the restoration of damaged tissue option for these patients. The Phase rates through restoration of heartmedicine by representing and prompted the patients heart to I and Ib studies produced encourag- function. produce its own stem cells, which ing, though preliminary, indications and supporting the community of companies, academic + Regenerative Medicine—In Brief research institutions, What is regenerative medicine? tissue and renew biologic products addressing many morepatient advocacy groups, Regenerative medicine (RM) is a function in the body is what conditions advancing in clinical foundations, and other rapidly evolving interdisciplinary distinguishes RM from other trials. RM holds the promise oforganizations before the field in health care that trans- types of treatments and brings treating a broad range of dis- Congress, federal lates fundamental knowledge in new hope for dramatically eases that collectively representagencies and the general biology, chemistry and physics improving clinical outcomes and a substantial burden to our public. into materials, devices, systems curing disease. healthcare system, including and therapeutic strategies, What diseases can RM treat? acute and chronic conditions For more information, including cell-based therapies, such as diabetes, congestive RM products are currently on please visit us online at: which augment, repair, replace the market for the treatment of heart failure, Parkinson’s www.alliancerm.org or regenerate organs and wounds, cartilage defects, and disease, stroke, renal disease, tissues. The ability to repair diabetic foot ulcers, with spinal cord injury, and ALS.