What's Happening At The
McGowan Institute?

April 2005 | VOL. 4 | www.McGowan.pitt.edu

McGowan Faculty Recognized

Clemson Award-Dr. Badylak
Carnegie Science Center Awards for Excellence-Drs. Badylak and Woo

Clemson Award for Applied Research-Dr. Badylak
Stephen Badylak, DVM, MD, PhD is the 2005 recipient of the prestigious Clemson Award for Applied Research. The selection is based on the work of the candidate that has resulted in significant utilization or application of basic knowledge in science to accomplish a significant goal in the biomaterials area. The achievement will be evidenced by the development of a useful device or material which has achieved widespread usage or acceptance, or expanded knowledge of biomaterials/host tissue relationships which have received widespread acceptance and resulted in improvements in the clinical management of disease.

Dr. Badylak discovered that a strong, pliable tissue harvested from porcine small intestine provides an inductive scaffold for host cells to replace and repair damaged tissue. This biomaterial is called small intestinal submucosa, or SIS, and it is a naturally-occurring, complex matrix that is easy to handle, yet strong enough to hold sutures and provide support for weakened tissue.

As a naturally-derived, extracellular matrix (ECM) material, SIS is not chemically cross-linked. Since SIS is taken from a biological source and is processed to remove all cells, it is biocompatible and safe for human use. It is sterilized to eliminate pathogens and provide a long shelf life.

The initial SIS science developed by Dr. Badylak and his colleagues was subsequently licensed to DePuy, Inc. and Cook Biotech, Inc. These companies today market a variety of products whose origin is the Badylak SIS technology.

Success is measured in the significance and the frequency of outcomes. In the case of SIS-based clinical procedures, success has clearly arrived. SIS-clinical tissue engineering procedures have now assisted over 300,000 patients.

In terms of his continuing commitment, more exciting results are emerging from the Badylak laboratories. Using extracellular matrix technologies he will soon be ready to launch a clinical trial for the repair of damaged esophagus. Typically corrective action is required due to cancer or traumatic injury. Currently, the only means to address esophageal repair is to remove the damaged section of the esophagus and then pull the stomach up so that the shortened esophagus can be reconnected. The illustration shows the procedure to use a section of SIS extracellular matrix (ECM) material that replaces the damaged section of the esophagus; in preclinical trials, the ECM translates to esophageal-like tissue within several months. Soon, Dr, Badylak will be able to help patients who need esophageal repair, where the current “solution” means a significantly reduced quality of life.

Dr. Badylak’s received his award on April 27, 2005 for his pioneering research and his commitment to clinical translation that has had a profound impact on over 300,000 million patients, and in recognition of his continued pursuit of other challenging clinical needs.

Carnegie Science Center Awards for Excellence-Drs. Badylak and Woo
The Carnegie Science Center established the Awards for Excellence program in 1997 to recognize and promote outstanding science and technology achievements in western Pennsylvania. Nomination categories include advanced manufacturing, catalyst, corporate innovation, elementary educator, entrepreneur, environmental, high school educator, information technology, life sciences, media, middle-level educator, start-up entrepreneur and university/post-secondary educator.

Dr. Stephen Badylak is the 2005 Carnegie Science Center Life Sciences Award recipient for his pioneering research and his commitment to clinical translation that has had a profound impact on over 300,000 patients, and for his continued pursuit of other challenging clinical needs suggests, as detailed in the Clemson Award (above).

Dr. Savio L-Y. Woo received Honorable Mention in the 2005 Carnegie Science Center Life Sciences Award. Professor Woo is a champion to the scientific community, to the orthopaedic medical community and to the person on the street (who suffers from ligament damage). While there are a few who have risen to this high level of esteem in one of the categories, seldom is this the case in all three areas.

Dr. Woo is internationally recognized for his far-reaching contributions to the fields of biomechanics and sports medicine through his in-depth investigation of the complex function of knee ligaments and his wide spectrum of research in biomechanics. Through his knowledge and understanding of complex ligaments and tendons, his concept of “Controlled Motion is Good” has benefited surgical management and developed techniques to allow athletes to return to sports activities more quickly with an improved outcome. While the visibility of this technology is primarily focused on athletes, his results are also being applied to “the person on the street” with the same outstanding results.

In the area of ligament reconstruction Dr. Woo has developed and demonstrated the use of a novel robotics/UFS testing system to assess the function of ligaments in normal and reconstructed joints. This system, pioneered by Dr. Woo and his team, allows the measurement of joint motion in multiple degrees-of-freedom, as well as the determination of the corresponding forces in the ligaments. Through the use of this system, scientists and clinicians are now able to better understand the function of knee ligaments, as well as to suggest improved surgical procedures.

His research has led the way in revolutionizing the field of orthopaedic biomechanics. Now, laboratories, not only in the United States but around the world, are beginning to install similar systems.

One of the best metrics of scientific achievement is recognition by peers; Dr. Woo was the 7th individual in the U.S. to be inducted into the Institute of Medicine (1991) and National Academy of Engineering (1994). In 1998, Dr. Woo was awarded an Olympic Gold Medal at the Nagano games – the IOC Olympic Prize for Sports Sciences -- for his research contributions to the field of sports medicine.

In addition to his many professorships and collaborations, Dr. Woo is also the chairman of the International Olympic Committee (IOC) Academy, working closely with the IOC Medical Commission.

Congratulations to Dr. Woo for his recognition by the Carnegie Science Center.

 

NIH Funds Two SBIR Grants

…to Help Move Circulatory Support Devices toward Clinical Use

In partnership with other scientists and two medical device manufacturers, Dr. Harvey Borovetz has received funding from NIH on two Small Business Innovation Research (SBIR) grants that will expedite the movement of promising mechanical circulatory support devices from the lab to the clinic:

For a SBIR entitled "Development of a Magnetically Driven Heart Pump", this Phase II award to Levitronix seeks to address an unmet need for mechanical circulatory support in children with heart failure. Pediatric heart patients possess several unique features, such as small body size, reduced blood volume, and altered hemodynamic properties, which distinguish them from adults with heart failure. The project seeks to account for these features by developing a miniature, low-cost, centrifugal ventricular assist device for use as an extracorporeal mechanical support system.

The approach features a magnetically levitated, and thus friction-less, rotor/stator configuration, which efficiently generates flow, with minimum hemolysis. The major advantages of the current design are its small and relatively simple extracorporeal design, its ability to efficiently regulate pump output over a large range of flow conditions, and its ease of production.

In Phase I, Levitronix, in collaboration with the University of Pittsburgh, demonstrated the soundness of this technology for the pediatric application. In Phase II the focus will be on completion of the design and validation of the product, and to launch device readiness testing in anticipation of clinical trials.

Dr. Borovetz notes that this technology, which provides effective left ventricular assistance with a small, disposable device, will provide needed benefits to the health of children with severe cardiac disease, while not adding significantly to the cost of caring for these patients.

The second award is for a Phase I SBIR entitled "Circulatory Support Device for Toddlers/Small Children" where Dr. Borovetz is collaborating with LaunchPoint, LLC, Carnegie Mellon University (CMU), Children’s Hospital of Pittsburgh (CHP), and MedQuest. ™

The overall goal of this grant is to develop a safe, reliable, and biocompatible ventricular assist device (VAD) for toddlers/small children, between 15 and 35kg (two to twelve years of age). Treatment options for this population, typically suffering from ventricular failure due to congenital and acquired heart disease, remain very limited in spite of the success of ventricular assistance in adults. The "Toddler VAD" (TVAD) will utilize a centrifugal pump design with blood-lubricated bearings, optimized to minimize blood trauma and thrombosis. The device will be fully implantable, and capable of providing extended support (3 months).

The research consortium has special expertise in cardiovascular bioengineering, computational fluid dynamics (CFD), blood damage modeling, control theory, electromagnetics, motor development, biocompatibility, and biorheology.

Both of these pioneering efforts when they reach clinical use will offer opportunities to help young children through challenging days until other therapies can correct their cardiac problems.

 

School of Health and Rehabilitation Sciences Turns 35

Pitt’s youngest Health Sciences school is a baby no more, as this academic year marks the 35th anniversary of the founding of the School of Health and Rehabilitation Sciences (SHRS).

Established on Jan. 1, 1969, the School of Health Related Professions (SHRP) as it was originally known, was launched with the mission “to educate entry-level practitioners in a variety of health related professions and to prepare established clinicians.”

By 1971, SHRP graduates numbered 31 baccalaureate, 10 master’s and 18 post-baccalaureate certificate students taught by 23 full-time faculty. Those numbers today are nearly 800 students and 76 faculty.

Under the leadership of Dean Clifford Brubaker (right), who arrived to head the school in 1991, a number of rapid and significant changes have taken place:

  • Re-naming the SHRP the School of Health and Rehabilitation Sciences in part to reflect new awareness and increased emphasis nationally on education, research and assistive technology following enactment of the 1990 Americans With Disabilities Act.
  • New programs and departments were established, including the Department of Rehabilitation Science and Technology, and launched a now-thriving doctoral program.
  • The School runs jointly with the University of Pittsburgh Medical Center programs and clinical centers such as the Center for Assistive Technology and the Human Engineering Research Laboratories.
  • Several SHRS programs are ranked nationally in the most recent U.S. News and World Report’s graduate school guide, including: physical therapy, 3rd; speech/language pathology, 10th; audiology, 13th, and occupational therapy, 14th.
  • A new program in emergency medicine was created (1997).
  • The Department of Communication Science and Disorders from Arts and Sciences was completed (1998).
  • A certificate program in disabilities studies was added (2000).
  • Sports medicine and athletic training became a part of SHRS in 2001, moving from the School of Education, and were then combined with clinical dietetics and nutrition in 2003 to become the Department of Sports Medicine and Nutrition.
  • Doctoral programs in physical therapy and audiology were approved in 2002.

SHRS celebrated its 35th anniversary with a special alumni day April 9.

Adapted from an article by Peter Hart, University Times, March 31, 2005

 

Artificial Hearts Move Into Mainstream

There was a time when heart failure was a death sentence. That was before heart transplantation. Practically overnight, the availability of the surgery gave many patients new hope for survival.

Still, the problem with transplantation, in addition to being a gravely serious surgery with no guarantees of success, was that too few donor hearts are available to help the thousands of people who enter the transplant waiting list each year.

Artificial pumping devices that give the failing heart a bit of help have proved to be a win, keeping many people alive long enough to receive a donor heart.

In some cases physicians find that when a patient receives an artificial pumping device their heart, relieved of the full burden of pumping the body's blood by the help of the assist device, begins to heal eliminating the need for transplantation.

Work being done at the McGowan Institute today promises changes tomorrow in how a multitude of diseases are treated, as researchers discover ways to help the body heal itself, and discover ways to improve the size and effectiveness of life saving technologies.

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Dr. Patel-Best Overall Paper

Dr. Amit Patel, MS, MD, Director, Director of Cardiac Stem Cell Therapies - McGowan Institute is the recipient of the Best Paper Award at the 44th Annual Meeting North Texas Chapter of the American College of Surgeons. Dr. Patel was the lead author for the paper “Minimally Invasive Cellular Therapy for Congestive Heart Failure: A Prospective Randomized Study “. This research was the first comprehensive study where heart failure patients received stem cells in a minimally invasive procedure, and there was demonstrated evidence of improved heart function after the therapy.

While preliminary, the results of the prospective randomized trial indicate that a minimally invasive approach to cell therapy is feasible for the estimated 40 percent of heart failure patients whose disease is unrelated to coronary blockages and who therefore cannot benefit from bypass procedures. Moreover, the experience so far suggests the novel stem-cell approach may be a viable treatment for these and other heart failure patients, reported Dr. Patel, director of clinical cardiac cell therapies at the McGowan Institute.

The study took place at centers in South America. The research team obtained the necessary institutional and government health agency approval and each patient provided informed consent.

Dr. Patel and his colleagues are in discussions with the U.S. Food and Drug Administration and hope to receive the agency’s approval to conduct a trial at the University of Pittsburgh that would involve giving stem cells to patients who are being implanted with heart assist devices. When a donor heart becomes available for transplantation, the native heart would be removed, allowing researchers the rare opportunity to look at the heart in its entirety and to more closely examine the effects of the stem cells.

If approved, the protocol will be performed under the umbrella of the newly established Center for Cardiovascular Cellular Therapy, a collaboration that includes the McGowan Institute, the University of Pittsburgh School of Medicine’s department of surgery, the University of Pittsburgh Schools of the Health Sciences and the University of Pittsburgh Medical Center. The center will encompass clinical and research programs focused on the use of stem cells as an adjuvant treatment for a wide array of heart failure patients and for those with peripheral vascular disease.

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New Computational Cluster Facilitates Genetics Research

The Graduate School of Public Health has installed a new Apple Xserve G5 computing cluster to solve double-helix puzzles in human genetics every day – and faster than a speeding FBI-issue bullet.

The 125-node Xserve cluster serves more than 30 investigators and scientific teams including McGowan Faculty Member David Whitcomb, M.D., Ph.D., professor of medicine, cell biology and physiology and human genetics.

Dr. Whitcomb has done extensive studies on the genetic basis of pancreatic cancer, the fifth leading cause of cancer death in the United States. He is excited about the human genetics cluster’s capacity to increase productivity on these studies, as well as others he is pursuing on pancreatitis – recurrent inflammation of the pancreas – that can lead to pancreatic cancer.

“We are looking at the possible interactions of multiple genes and environmental factors in our group of patients,” he said. “There are thousands of possible genetic and environmental factors that might combine to result in disease. The computer can help to predict which factors are disease-causing and which are innocent bystanders.”

This is done by simulating an entire population of people and “testing” a group of imaginary patients with laboratory results from actual patients tens of thousands of times, explained Dr. Whitcomb. Eventually, the computer is able to sort out the genetic and environmental factors that may cause complex diseases.

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Transplant Recipients International Honors Two Transplant Doctors

The Pittsburgh Chapter of Transplant Recipients International Organization (TRIO) honored transplant surgeon Kenneth R. McCurry, M.D., and transplant pulmonologist James H. Dauber, M.D., at its annual dinner on April 18, 2005. The event’s theme, A New Breath of Life, paid tribute to their work in lung transplantation and kicked off National Organ and Tissue Donor Awareness Week for the Pittsburgh region.

Kenneth R. McCurry, M.D.
James H. Dauber, M.D.

Dr. McCurry is assistant professor of surgery in the division of cardiothoracic surgery and director of Adult Lung and Heart-Lung Transplantation, co-director of Adult Cardiac Transplantation and surgical director of Pediatric Lung and Heart-Lung Transplantation. He also is active in cardiac surgery, with an interest in heart failure surgery. Dr. Dauber is professor of medicine, division of pulmonary, allergy and critical care medicine and past medical director of pulmonary transplantation at UPMC.

TRIO is an organization devoted to improving the quality of lives of those touched by the miracle of transplantation through support, advocacy, education and awareness.

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