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Advances in Adult Stem Cell Therapy in Tissue Repair for Cardiovascular Diseases


for Members

Advances in Adult Stem Cell Therapy in Tissue Repair for Cardiovascular Diseases

Wednesday, November 30, 2011

The New York Academy of Sciences

Presented By


Over the years, a plethora of different therapeutic approaches have been discovered and developed in an effort to treat patients with the most severe forms of cardiovascular diseases, including critical limb ischemia (CLI) and chronic heart failure. These approaches have ranged from small molecules, biologics, devices, gene therapy (using growth factors such as HIF, VEGF, FGF), and, more recently, cell therapy. While some of these therapeutic approaches are effective at first, these chronic diseases progress with time until there are no more viable therapeutic options. Very limited surgical options are frequently the last resort, either heart transplantation or a left ventricular assist device placement in the case of chronic heart failure or limb amputation in the case of CLI. The objective of today's current standard of care is to halt or delay disease progression. In contrast, regenerative medicine therapies strive to rebuild and restore the structure and function of the damaged or diseased tissues. An increasingly studied regenerative medicine approach is to use adult stem cells to repopulate and promote the healing process in damaged or diseased tissues. Cell therapy can now be derived from a variety of sources, from embryos and placentas to different types of adult tissues. The most widely studied and most advanced type of cell therapy now in clinical trials utilizes cells derived from bone marrow. Bone marrow derived stem cells, either used immediately or cultured to significantly expand the essential cell populations, have been studied in a variety of chronic cardiovascular diseases with promising results in clinical trials. Various autologous or allogeneic adult stem cell therapies are about to be evaluated in pivotal, randomized Phase III trials, underscoring the potential clinical benefit of this approach. The objective of this symposium is to provide a review of recent advances in the field, and to show how this work is translating into new approaches to treat difficult-to-treat, chronic cardiovascular diseases, ranging from compelling preclinical data to mid-stage clinical trial results.

Networking reception to follow.

Registration Pricing

Student / Postdoc / Fellow Member:$0
Student / Postdoc / Fellow Nonmember:$15



* Presentation times are subject to change.

Wednesday, November 30, 2011

12:00 PM


12:30 PM

Opening Remarks
Jennifer Henry, PhD, The New York Academy of Sciences
Tim Mayleben, Aastrom Biosciences, Inc.

12:45 PM

MSCs are the New Medicine!
Arnold Caplan, PhD, Case Western Reserve University

1:25 PM

Type 2 Diabetes Restricts Mesenchymal Stem Cell Multipotency and Impairs their Capacity to Augment Post-Ischemic Neovascularization in db/db Mice
Louis Messina, MD, UMass Memorial Medical Center

2:05 PM

The Myopathy of Peripheral Arterial Disease
Iraklis Pipinos, MD, PhD, University of Nebraska

2:45 PM

Coffee Break

3:10 PM

Patient-Specific Cellular Therapy (Ixmyelocel-T) is Safe and Improves Time to Treatment Failure in Patients with Critical Limb Ischemia and No Revascularization Options
Sharon Watling, PharmD, and Ronnda Bartel, PhD, Aastrom Biosciences Inc.

3:50 PM

Panel Discussion: Adult Stem Cell Therapy: Is It the Next Big Advance in the Treatment of CLI and DCM?
All speakers, moderated by George B. Zavoico, PhD, MLV

4:30 PM

Networking Reception

5:30 PM

Program Ends



Tim Mayleben

Aastrom Biosciences, Inc.

Mr. Mayleben joined Aastrom as a member of the Company's Board of Directors in June 2005, and has served as Chief Executive Officer, President, and Director since December 2009. Mr. Mayleben was formerly an advisor to life science and healthcare companies through his advisory and investment firm, ElMa Advisors. Prior to this he served as the President and Chief Operating Officer and a Director of NightHawk Radiology Holdings, Inc. Mr. Mayleben was also formerly the Chief Operating Officer of Esperion Therapeutics, which later became a division of Pfizer Global Research & Development. He joined Esperion in late 1998 as Chief Financial Officer. While at Esperion, Mr. Mayleben led the raising of more than $200 million in venture capital and institutional equity funding and later negotiated the acquisition of Esperion by Pfizer in December 2003. Prior to joining Esperion, Mr. Mayleben held various senior and executive management positions at Transom Technologies, Inc., now part of Electronic Data Systems, Inc., and Applied Intelligent Systems, Inc., which was acquired by Electro-Scientific Industries, Inc. in 1997. Mr. Mayleben holds a Masters of Business Administration, with distinction, from the J.L. Kellogg Graduate School of Management at Northwestern University, and a Bachelor of Business Administration degree from the University of Michigan Ross School of Business. He is on the Advisory Board for the Wolverine Venture Fund and serves as a director for several private life science companies.

George B. Zavoico, PhD


George B. Zavoico, PhD, is Managing Director, Research, and a Senior Equity Research Analyst at MLV, a boutique investment bank and institutional broker-dealer based in New York. He has over 6 years of experience as a life sciences analyst writing research on publicly traded equities. Prior to MLV, he was an equity analyst with Westport Capital Markets and Cantor Fitzgerald. Prior to working as an analyst, Dr. Zavoico established his own consulting company serving the biotech and pharmaceutical industries by providing competitive intelligence and marketing research, due diligence services, and guidance in regulatory affairs. He also wrote extensively on healthcare and the biotech and pharmaceutical industries for periodicals targeting the general public and industry executives. Dr. Zavoico began his career as a Senior Research Scientist at Bristol-Myers Squibb Co., moving on to management positions at Alexion Pharmaceuticals, Inc. and T Cell Sciences, Inc. (now Celldex Therapeutics, Inc.). He has a BS in Biology from St. Lawrence University and PhD in Physiology from the University of Virginia and has held post-doctoral positions at the University of Connecticut Health Sciences Center and Brigham and Women's Hospital and Harvard Medical School.

Jennifer S. Henry, PhD

The New York Academy of Sciences


Ronnda Bartel, PhD

Aastrom Biosciences, Inc.

Ronnda joined Aastrom in 2006 and is responsible for research, development and manufacturing and engineering operations. She has more than 20 years of research and product development experience and most recently was executive director, biological research at MicroIslet and vice president, scientific development at StemCells Inc. Earlier in her career, she was senior principal scientist, cell biology at Advanced Tissue Sciences and was involved in the development and approval of some of the first cell-based products approved by the FDA. She has also worked as senior director, science and technology at SRS Capital, LLC evaluating life science investments and has held positions in clinical development, drug delivery, business development and manufacturing. Ronnda holds a PhD in biochemistry from the University of Kansas, has completed postdoctoral work at the University of Michigan and received a BA in chemistry and biology from Tabor College.

Arnold I. Caplan, PhD

Case Western Reserve University

Arnold I. Caplan, Professor of Biology and Director of the Skeletal Research Center at Case Western Reserve University. He received his PhD from The Johns Hopkins University School of Medicine. Dr. Caplan is a national and international scholar focusing on experimentation in the area of musculoskeletal and skin development. He has published over 375 papers and manuscripts and has long been supported by the NIH and other non-profit and for-profit agencies for his efforts in trying to understand the development, maturation and aging of cartilage, bone, skin and other mesenchymal tissues and for his pioneering research on Mesenchymal Stem Cells.

Louis Messina, MD

UMass Memorial Medical Center

Louis M. Messina, MD, Chief, Division of Vascular & Endovascular Surgery at UMass Memorial Health Care and Vice Chair for Research, Department of Surgery, is Professor of Surgery at the University of Massachusetts Medical School. He maintains clinical interests in carotid and lower extremity arterial occlusive disease, complex aortic and renal/mesenteric disease, thoracic outlet syndrome, and pediatric vascular reconstruction.

Dr. Messina is a Summa Cum Laude graduate of the State University of New York, Downstate Medical Center in Brooklyn. He completed both his Surgical Residency and Vascular Surgery Fellowship at the University of California, San Francisco, CA, and completed a two-year research fellowship at the Cardiovascular Research Institute in San Francisco.

Dr. Messina has longstanding NIH grant funding to investigate the role of eNOS in collateral artery enlargement as well as the role of bone marrow-derived stem cells on the revascularization of the ischemic limb. He has over 130 peer-reviewed publications, and has been supervisor to more than 20 post-doctoral researchers. He has co-authored over 80 book chapters and five books. He is the Associate Editor of the Journal of Vascular Surgery and the Associate Editor of Rutherford's Vascular Surgery, each the leading publication in its field.

Iraklis Pipinos, MD, PhD

University of Nebraska Medical Center

Dr. Iraklis Pipinos is a Professor of Surgery at the University of Nebraska Medical Center. Dr. Pipinos concentrates his clinical practice in vascular surgery at the VA Nebraska and Western Iowa where he is the Chief of the Vascular Surgery section. Dr. Pipinos' clinical efforts focus on open and endovascular surgery, with a particular interest on carotid and peripheral arterial operations. The major focus of the laboratory of Dr. Pipinos and his collaborator Dr. Casale is the development of regenerative medicine strategies for skeletal muscle tissue in the legs of patients suffering from peripheral arterial disease (PAD). PAD afflicts 5% of the US population older than 55 years of age and develops along with hardening (atherosclerosis) of the arteries of the legs. The laboratory of Drs. Pipinos and Casale is funded by the NIH (NIA and NHLBI) and evaluates the mechanisms that produce the clinical manifestations of PAD. The objective of the work performed in the laboratory is to improve patient prognosis and produce significant new diagnostic and treatment strategies for the care of patients with PAD.

Sharon Watling, PharmD

Aastrom Biosciences, Inc.

Sharon Watling joined Aastrom in February 2010 and is responsible for clinical development, clinical operations and regulatory affairs. Dr. Watling has over 12 years of experience in clinical development, with an emphasis on translational and early stage development, as well as development of clinical strategies. Her industry career started in late stage development within Warner-Lambert/Parke Davis and evolved while at Pfizer to include an early clinical leadership role in cardiovascular-metabolic diseases. Following Pfizer, she was Site Leader and Senior Director, Clinical Development at Metabasis, Inc. Most recently, she served as the Research and Development Strategy Leader at Cognigen Corporation, working with multiple companies to incorporate modeling and simulation practices into their development strategies. Prior to industry, she was an intensive care unit clinical specialist at various academic institutions. Dr. Watling received a Doctor of Pharmacy Degree from the University of Michigan College of Pharmacy.


  • Aastrom


MSCs Are the New Medicine!
Arnold I. Caplan, PhD, Case Western Reserve University

Marrow derived adult Mesenchymal Stem Cells (MSCs) can be isolated and culture expanded. Although these cells are capable of differentiating into lineages that result in the fabrication of bone, cartilage, muscle, marrow stroma, tendon/ligament, fat and other connective tissues, MSCs have recently been shown to be intrinsically therapeutic. Such culture expanded adult/MSCs are immuno-modulatory especially in muting T-cells and, thus, allogeneic MSCs have been used to mute or cure graft-versus-host-disease and Crohn's disease and are now being tested in certain autoimmune diseases. Furthermore, these allo-MSCs set-up a regenerative micro-environment which is anti-apoptotic, anti-scarring, mitotic for tissue intrinsic progenitors and angiogenic. These immuno and trophic activities result from the secretion of powerful bioactive molecules that, in combination, support localized regenerative event. The MSCs reside in every tissue of the body and function as perivascular cells (pericytes) until a focal injury occurs. At sites of injury the pericyte is released and functions as a MSC that provides molecular assistance in activities leading to tissue regeneration. Such assistance involves many tasks involving the immuno-protection and trophic activities provided by the MSCs.

Type 2 Diabetes Restricts Mesenchymal Stem Cell Multipotency and Impairs their Capacity to Augment Post-Ischemic Neovascularization in db/db Mice
Louis Messina, MD, UMass Memorial Medical Center

db/db mice, a model of type 2 diabetes, demonstrate a significant adipocyte infiltration of ischemic muscles and impaired blood flow recovery after hind limb ischemia. To determine the origin of this adipocyte infiltration and evaluate the role of mesenchymal stem cells (MSCs) in this aberrant db/db response, we transplanted GFP-labeled MSCs from db/db or C57BL/6 (WT) mice into WT recipients after induction of hind limb ischemia. Recipients receiving db/db MSCs demonstrated adipocyte infiltration of ischemic muscle and reduced foot blood flow recovery; recipients of WT MSCs had enhanced foot blood flow recovery and no adipocytic infiltration. In vitro, db/db MSCs exhibited greater oxidant stress, greater adipocytic differentiation, and less endothelial differentiation than WT MSCs and these differences were reversed by N-acetylcysteine or Nox4 siRNA. Insulin increased Nox4 expression, oxidant stress, and adipocytic differentiation in WT MSCs, and these insulin-induced effects were reversed by Nox4 siRNA. Diet-induced diabetic mice (DIDM) had responses that were qualitatively similar to db/db mice. These findings indicate that type 2 diabetes induced-oxidant stress restricts MSC multipotency and impairs their capacity to increase blood flow recovery after the induction of hind limb ischemia. Reversal of MSC oxidant stress might permit greater leverage of the therapeutic potential of MSC transplantation in the setting of type 2 diabetes.

The Myopathy of Peripheral Arterial Disease
Iraklis Pipinos, MD, PhD, University of Nebraska Medical Center

In recent years, an increasing number of studies have demonstrated that a myopathy is present, contributes, and, to a certain extent, determines the pathogenesis of peripheral arterial occlusive disease. These works provide evidence that a state of repetitive cycles of exercise induced ischemia followed by reperfusion at rest operates in patients with peripheral arterial occlusive disease and mediates a large number of structural and metabolic changes in the muscle, resulting in reduced strength and function. The key players in this process appear to be defective mitochondria that, through multilevel failure in their roles as energy, oxygen radical species, and apoptosis regulators, produce and sustain a progressive decline in muscle performance. In this talk, the currently available evidence that characterize the nature and mechanisms responsible for this myopathy is highlighted. Furthermore, accumulating evidence that oxidative stress (related to ischemia reperfusion) and inflammation are probably critical operating mechanisms in the pathophysiology of the myopathy will be presented. Learning more about these mechanisms will enhance our understanding of the degree to which they are preventable and treatable.

Patient-Specific Cellular Therapy (Ixmyelocel-T) is Safe and Improves Time to Treatment Failure in Patients with Critical Limb Ischemia and No Revascularization Options
Sharon Watling, PharmD, and Ronnda Bartel, PhD, Aastrom Biosciences, Inc.

Critical limb ischemia (CLI) represents the most severe degree of peripheral arterial disease and is associated with significant morbidity and mortality. Cellular therapy offers the potential to promote tissue remodeling, immuno-modulation, and angiogenesis. This Phase 2 study assessed the safety and efficacy of patient-specific, expanded bone marrow cells (ixmyelocel-T) in a no-option CLI population followed for 12 months. This randomized (2:1), double-blind, placebo-controlled, multicenter study compared one-time treatment of ixmyelocel-T with placebo, administered via 20 IM lower extremity injections. Bone marrow aspirates from patients in the ixmyelocel-T group were processed over 12 days to generate ixmyelocel-T mixed cell product. The primary objective was safety. A composite treatment failure efficacy endpoint (major amputation on treated limb, death, doubling of wound size from baseline, or de novo gangrene) and amputation-free survival (major amputation or death) were also evaluated. Full results from the presentation at American Heart Association presented on Monday November 14, 2011 will be presented. Ixmyelocel-T was safe and increased time to treatment failure.

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