products addressing many more conditions advancing in clinical trials. RM holds the promise of treating a broad range of dis-eases that collectively represent a substantial burden to our healthcare system, including acute and chronic conditions such as diabetes, congestive heart failure, Parkinson’s disease, stroke, renal disease, spinal cord injury, and ALS.

tissue and renew biologic function in the body is what distinguishes RM from other types of treatments and brings new hope for dramatically improving clinical outcomes and curing disease.

What diseases can RM treat?

RM products are currently on the market for the treatment of wounds, cartilage defects, and diabetic foot ulcers, with

What is regenerative medicine?

Regenerative medicine (RM) is a rapidly evolving interdisciplinary field in health care that trans-lates fundamental knowledge in biology, chemistry and physics into materials, devices, systems and therapeutic strategies, including cell-based therapies, which augment, repair, replace or regenerate organs and tissues. The ability to repair

of efficacy of this form of treatment. Aldagen, a North Carolina-based company, has completed a Phase I trial in heart failure patients for which the company’s cell therapy was shown to improve the move-ment of blood in the heart and improve patients’ clinical status. Aldagen is developing its therapies from patient’s own bone marrow using propriety technology to isolate cells that are able to improve blood flow to ischemic tissues. Aldagen is planning to commence Phase II trials for ischemic heart failure — as well as critical limb ischemia and stroke — in 2011.

Athersys has developed MultiStem®, an off-the-shelf stem cell therapy using donated adult cells from bone marrow and other non-embryonic sources for targeted treatments of multiple conditions, including heart attack, inflammatory bowel disease, and ischemic stroke. The Ohio-based company recently completed a Phase I trial for heart attack, which showed that MultiStem® is safe and appeared to improve heart function through several mechanisms. The company is planning to initiate Phase 2 studies in heart attack and stroke in 2011.”

Cytori, located in California, markets the Celution® System for extracting and concentrating adipose (fat)-derived stem and regenerative cells (ADRCs) used in research and which may ultimately be used in various forms of therapy. Cytori is also sponsoring two clinical trials using patient’s own ADRCs to treat acute heart attack and chronic myocardial ischemia, with the aim of reducing post-incident disability and mortality rates through restoration of heart function.

Cardiovascular disease (CVD), which affects a person’s heart and circulatory system, are highly prevalent among the general population and represents the leading causes of death and disability in the U.S., leaving a substantial impact on our national health care infrastructure. The most recent studies completed by the American Heart Association (AHA) estimate that 36% of Americans currently suffer from some form of CVD. This includes the 12% of Americans who experienced heart attack, congestive heart failure, or stroke in 2010. While symptoms of these CVDs vary widely, survivors of the most acute conditions often undergo life-changing treatments ranging from daily medications to surgical interventions such as pace makers, angioplasty, or heart transplants. Patients with heart disease, especially those who have survived acute events, often suffer from long-term disabilities, loss of productivity, and diminished quality of life.

CVD is generally progressive and often necessitates more significant medical interventions over time, highlighting the need for innovative and effective treatments that can repair damaged cardiac muscle and revascularize obstructed veins and arteries. Regenerative medicine technologies could fill this need by using living cells as therapies to help stimulate the growth of functional heart muscle. The most recent scientific evidence for this approach came from the University of Miami, where a small human trial for heart attack showed that patients infused with stem cells extracted from their own bone marrow replaced scar tissue and reduced enlarged hearts by up to 25%. The stem cells fostered the restoration of damaged tissue and prompted the patient's heart to produce its own stem cells, which

created additional functioning heart muscle. Several Alliance members are conducting clinical trials in CVD. Specifically, ARM members are working on new therapies to address heart attack, ischemic heart failure, congestive heart failure, dilated cardiomyopathy and stroke (see the ‘Stroke’ disease spotlight for more information):

Aastrom Biosciences, located in Michigan, is in a Phase II trial for an autologous (self-donated) stem cell therapy using cardiac repair cells (CRCs) to treat cardiomyopathy. This condition causes the heart muscle to deteriorate, leaving patients vulnerable to arrhythmia or sudden death. Between 200,000 and 400,000 Americans are affected by cardiomyopathy. The current standard of treatment is limited to heart transplant or the use of mechanical pumps, whereas Aastrom’s approach of infusing patients with CRC's is predicted to help the body activate its own healing mechanisms.

Advanced Cell Technology, with offices in Massachusetts and California, is approved by the FDA to begin a Phase II study for congestive heart failure (CHF). ACT’s product candidate uses the patient’s own myoblasts (adult muscle stem cells that can form muscle fibers) to repair damaged heart muscle and promote new blood vessels in the damaged area. CHF is an end-stage CVD that leaves patients with few options other than heart transplant. By using a catheter delivery technique, ACT’s approach potentially offers a safer (compared to the risks of transplant) and more cost-effective treatment option for these patients. The Phase I and Ib studies produced encourag-ing, though preliminary, indications

+ Multiple Approaches for Strengthening Weakened Hearts

+ Regenerative Medicine—In Brief

A l l i a n c e f o r R e g e n e r a t i v e M e d i c i n e - D i s e a s e S p o t l i g h t

Disease Facts: Description: + CVD is an umbrella term that encompasses a wide range of medical issues, including hypertension, stroke, heart attack, and coronary heart disease

Patients: + Affects 36% of Americans in some form + Incidence projected to increase to 40% by 2030 Current Costs: + $272 billion in direct costs + $171 billion in lost productivity

From the American Heart Association: “Cardiovascular disease (CVD) is the leading cause of death in the United States and is responsible for 17% of national health expenditures. As the population ages, these costs are expected to increase substantially.” - January 2011

Cardiovascular Disease (CVD)

The Alliance for Regenerative Medicine (ARM) was formed to advance regenerative

medicine by representing and supporting the

community of companies, academic research institutions,

patient advocacy groups, foundations, and other

organizations before the Congress, federal

agencies and the general public.

For more information,

please visit us online at: www.alliancerm.org