1. Alliance for Regenerative Medicine - Disease Spotlight
Disease 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-based
including hypertension, prevalent among the general Several Alliance members are company, has completed a Phase I
stroke, 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 therapy
coronary 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 and
Patients: 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 bone
Americans 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 in
increase 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 cell
Current 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 — in
costs 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 surgical
productivity 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-embryonic
From the American Heart standard of treatment is limited to sources for targeted treatments of
especially those who have survived
Association: 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 CRC's is predicted to company recently completed a Phase
of death in the United CVD is generally progressive and help the body activate its own I trial for heart attack, which showed
States and is responsible often necessitates more significant healing mechanisms. that MultiStem® is safe and
medical interventions over time, appeared to improve heart function
for 17% of national health highlighting the need for innovative Advanced Cell Technology, with
through several mechanisms. The
expenditures. 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 to
population 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 product
increase 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 heart
medicine by representing and prompted the patient's 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 more
patient 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 of
organizations 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 represent
agencies 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.