New Armed Forces Institute of Regenerative Medicine to lead way in caring for wounded

Washington D.C. 17 April 2008The Department of Defense has created a new, federally-funded institution, the Armed Forces Institute of Regenerative Medicine (AFIRM) during a briefing at the Pentagon. The AFIRM will be made up of two multi-institutional consortia, one led by Wake Forest University, Winston-Salem, North Carlina, and the University of Pittsburgh; and one led by Rutgers University, New Brunswick, New Jersey, and the Cleveland Clinic. Each group has been awarded $42.5 million. The United States Army Institute of Surgical Research in San Antonio, Texas, will work with these academic consortia to provide key guidance on military medical needs and conduct trials of new therapies.

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"Therapies developed by the AFIRM project will greatly benefit wounded warriors, as well as the civilian population with burns or severe trauma due to illness or injury", stated Dr. S. Ward Casscells, assistant secretary of defense for health affairs.

The AFIRM team is committed to developing clinical therapies over the next five years focusing on the following five areas:

  • Burn repair
  • Wound healing without scarring
  • Craniofacial reconstruction
  • Limb reconstruction, regeneration or transplantation
  • Compartment syndrome, a condition related to inflammation after surgery or injury that can lead to increased pressure, impaired blood flow, nerve damage and muscle death

"Following in the great military medical tradition of innovation, collaboration and progressive research, AFIRM will unify and apply all the recent breakthroughs in regenerative medicine while leading the charge to new ones", stated Dr. Casscells.

The United States Army Medical Research Material Command (USAMRMC), in conjunction with the Office of Naval Research, the National Institutes of Health, the Air Force Office of the Surgeon General and the Department of Veterans Affairs will fund the consortia. In addition to $85 million in defense funding, an additional $180 million from academic institutions, industry and state and federal agencies will be contributed - for a total of more than $250 million available for regeneration research.

"The new institute will work to develop techniques that will help to make our soldiers whole again", explained Lt. Gen. Eric Schoomaker, the United States Army surgeon general. "We're embarking on the next generation of research that is going to redefine the face of Army medicine. We're doing it with enthusiastic and skilled partners, and we're doing it for our wounded warriors."

The AFIRM is a strong national effort to address the unprecedented challenges of caring for service members returning from Afghanistan and Iraq with multiple traumatic injuries. Some of the wounded warriors face the daily challenges of recovery from severe limb, head, face and burn injuries that require years of treatment and may result in a significant lifetime impairment.

In addition to developing clinical treatments, the AFIRM will serve as a training facility to develop experts in treating trauma with regenerative medicine and will serve as a resource to help the military develop tissues as needs are identified.

The University of Pittsburgh's McGowan Institute for Regenerative Medicine and the Institute for Regenerative Medicine at Wake Forest University Baptist Medical Center have been selected as co-leaders of the national $85 million programme to use the science of regenerative medicine to develop new treatments for wounded soldiers. The Wake Forest-McGowan team includes collaborators from 15 other institutions.

"Researchers from the University's McGowan Institute for Regenerative Medicine are known throughout the world for their cutting-edge research that is providing real hope for dramatic advances in human health", stated Pitt Chancellor Mark A. Nordenberg. "The Institute has fast become one of the nation's leaders in developing organ and tissue technologies as viable clinical therapies, and through its involvement in AFIRM, the Institute will continue to progress in this vitally important area."

AFIRM will be co-directed by Alan J. Russell, Ph.D., director of the McGowan Institute for Regenerative Medicine, and Anthony Atala, M.D., director of the Wake Forest Institute for Regenerative Medicine. The massive project will be dedicated to repairing battlefield injuries through the use of regenerative medicine, science that takes advantage of the body's natural healing powers to restore or replace damaged tissue and organs. Therapies developed by AFIRM also will benefit people in the civilian population with burns or severe trauma due to illness or injury.

"Our goal is to use our position as the international leader in developing restorative therapies for battlefield trauma to improve the outcomes for our wounded", stated Dr. Russell, who is a founding president of the Tissue Engineering and Regenerative Medicine International Society (TERMIS). "Our ability to provide these treatments is in part due to our team's long experience in this field and our broad pipeline of technologies."

AFIRM will have multiple research teams working in each area. For example, in the area of burns, researchers will pursue treatments including engineered skin products, bio-printing of skin in the field and repairs using stem cells derived from amniotic fluid. Drs. Russell and Atala note that the team's ability to deliver 11 new treatments is based on a four-year history of the McGowan and Wake Forest institutes working in partnership with the United States Department of Defense on regenerative medicine projects.

"For the first time in the history of regenerative medicine, we have the opportunity to bring transformational technologies to wounded soldiers, and to do so in partnership with the armed services", stated Dr. Atala. "This field of science has the potential to significantly impact our ability to successfully treat major trauma."

Twenty-nine McGowan research teams in Pittsburgh will be joined by 16 at Wake Forest and 33 more research teams at 15 other institutions and companies focusing on regenerative medicine. Several treatments are now being evaluated in patients. More than 50 technologies from these researchers already have had an impact on treatments for illness and injury. Researchers associated with McGowan have launched more than 10 clinical trials - three with the Army - using tissue-engineered products that have now been implanted in more than 1 million patients.

Collaborators and subcontractors for the McGowan-Wake Forest team include Allegheny Singer Research Institute; the California Institute of Technology; Carnegie Mellon University; the Georgia Institute of Technology; the United States Army Institute for Collaborative Biotechnology; Intercytex Group Plc; Organogenesis Inc.; Oregon Biomedical Engineering Institute; the Pittsburgh Tissue Engineering Initiative Inc.; Providence Health System; Rice University; Stanford University; Tufts University; the University of California, Santa Barbara; and Vanderbilt University.

To realize the vast potential of tissue engineering and other techniques aimed at repairing damaged or diseased tissues and organs, the University of Pittsburgh School of Medicine and the University of Pittsburgh Medical Center have established the McGowan Institute for Regenerative Medicine to serve as a single base of operations for the university's leading scientists and clinical faculty working to develop tissue engineering, cellular therapies and artificial organ devices. The University of Pittsburgh Medical Center is the largest integrated health care enterprise in Pennsylvania and one of the leading non-profit health systems in the country.

Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university's School of Medicine. The system comprises 1154 acute care, psychiatric, rehabilitation and long-term care beds.

The Rutgers-led collaboration will be headed by Joachim Kohn, Board of Governors Professor of Chemistry and Chemical Biology in Rutgers' School of Arts and Sciences, and George Muschler, an orthopaedic surgeon at the Cleveland Clinic, Rutgers' principal partner in this undertaking.

The use of improvised explosive devices (IEDs) in Iraq and Afghanistan has caused a marked increase in severe blast trauma, now responsible for approximately 75 percent of all injuries, according to the Journal of Orthopaedic Trauma. Better body armor, quicker evacuation from the battlefield and advanced medical care have made it possible for injured soldiers to survive in greater numbers than in the past.

The new institute is a strong national effort to address the unprecedented challenges of caring for men and women returning from Afghanistan and Iraq with multiple traumatic injuries. "Our foremost goal is to alleviate the human suffering associated with debilitating blast injuries and to enable our injured people to return to productive lives", Joachim Kohn stated.

AFIRM will develop new products and therapies for the repair of battlefield injuries through the use of regenerative medicine. This innovative approach employs biological therapy, including stem cells and growth factors; tissue and biomaterials engineering; and transplants to enable the body to repair, replace, restore and regenerate damaged tissues and organs. The institute also will dramatically accelerate the rate at which promising biomaterials as well as cell-based and combined regenerative medicine technologies will be converted into new therapies to restore lost tissue and lost function. These products and therapies also will serve civilian trauma and burn patients.

Biomaterials will play a crucial role in developing new therapies for regenerating tissue and healing large wounds. The Rutgers team, with its strength in biomaterials science, has embarked on creating new methods to identify unique biomaterials compositions tailored to support the growth of new nerves, blood vessels, skin, bone or muscle. The team has pioneered the approach of creating libraries of hundreds of new biomaterials allowing the researchers to discover the best choices for specific medical indications. Once identified, the new biomaterials will be distributed to other AFIRM team members for the development of new clinical applications.

The Rutgers approach is based on using experimental screening assays in combination with computational modelling. The Rutgers group will work closely with its Massachusetts Institute of Technology partners who are developing complementary methods of screening large biomaterials libraries for specific properties.

Rutgers research and management activities associated with the institute will receive approximately $1,7 million per year, supplemented over the first two years by $400.000 from the New Jersey Commission on Science and Technology to be matched with another $400.000 by the university.

"The Rutgers community welcomes the opportunity to take a leadership role in this important pursuit", stated Rutgers President Richard L. McCormick. "What we do here will produce a durable and adaptable resource for the development and advancement of regenerative therapies for injured military personnel as well as civilian victims of trauma."

"The Cleveland Clinic with Rutgers, and our entire AFIRM team, is deeply committed to offering new recovery options for the brave men and women who have served our country", George Muschler stated. "Our mission, through combined effort, is to translate opportunities that are now available in regenerative biology, as rapidly as possible, into practical tools that can be used on the front lines or here at home."

The Rutgers-led component of the institute will be based on a highly integrated, open network of dedicated partners comprising 15 premier academic institutions and more than 20 leading companies. "New Jersey is the ideal centre for the AFIRM research and development effort. We are the home of the global pharmaceutical industry, have a strong concentration of medical device companies and are one of the first states to promote and fund a broad spectrum of stem cell research initiatives", New Jersey Gov. Jon S. Corzine wrote in a letter. "The conception of AFIRM as a partnership between military and civilian academic institutions is a groundbreaking idea for which I commend the USAMRMC."

Most of the partners in the Rutgers-led consortium have been professional colleagues for years with longstanding collaborations. The open network approach ensures that the most qualified experts and performance sites, irrespective of their institutional affiliation or geographic location, will be within reach. An executive committee headed by Joachim Kohn and George Muschler will direct the research programmes of the geographically dispersed network of leading academic research scientists and clinicians, industrial scientists and business managers, and military medical experts.

The core academic partners are: the New Jersey Center for Biomaterials at Rutgers University, the National Center for Regenerative Medicine at the Cleveland Clinic, Case Western Reserve University, University Hospitals Case Medical Center, Carnegie Mellon University, Stony Brook University, Dartmouth College, Massachusetts Institute of Technology, Massachusetts General Hospital/Harvard Medical School, the Mayo Clinic, Northwestern University, University of Cincinnati, University of Medicine and Dentistry of New Jersey, University of Pennsylvania, University of Virginia and Vanderbilt University. These core partners are supported by a large number of industrial collaborators and participating health care companies that have expressed an interest in the commercialization of new products and therapies emerging from institute's research programme.

Established in 1766, Rutgers, The State University of New Jersey, is America's eighth oldest institution of higher learning and one of the nation's premier public research universities. Serving more than 50.000 students on campuses in Camden, Newark and New Brunswick, Rutgers offers more than 280 bachelor's, master's, doctoral and professional degree programmes. The university is home to 27 degree-granting schools and colleges, and more than 150 specialized centres and institutes.

Rice University and the University of Texas (UT) Health Science Center at Houston will spearhead the search for innovative ways to quickly grow large volumes of bone tissue for craniofacial reconstruction for soldiers wounded in Iraq and Afghanistan.

"This is by far the largest federal investment ever made in regenerative medicine, and it's no coincidence that the Texas Medical Center is playing an important role", stated Rice University President David Leebron. "Rice and UT-Houston's collaborative research in this area is at the forefront of this rapidly growing field."

Rice bioengineer Antonios Mikos and UT-Houston surgeon Mark Wong are overseeing the Wake Forest consortium's research on craniofacial reconstruction. Antonios Mikos is Rice's J.W. Cox Professor in Bioengineering, professor of chemical and biomolecular engineering and the director of Rice's Center for Excellence in Tissue Engineering. Mark Wong is associate professor and chairman of the Department of Oral and Maxillofacial Surgery at the University of Texas Dental Branch at Houston. Rice and UT-Houston will receive $2 million over the next five years to spearhead the development of new tissue engineering technologies, novel reconstructive surgical techniques and innovative drug therapies that can help wounded soldiers.

"Dr. Mikos and Dr. Wong have been pioneers in the development of new tissue-engineering technologies that can be used for facial reconstruction for victims of catastrophic injury", stated Dr. Peter Davies, executive vice president for research at UT-Houston. Tissue engineering is a fast-growing biomedical discipline that aims to quickly grow human tissues like bone, cartilage and skin that can be surgically transplanted without risk of rejection. Tissue engineers often use a patient's own cells as the basis for new tissue, placing them on biodegradable templates and stimulating them with chemical and physical cues.

"All of our efforts, both here in Houston and around the nation, are aimed at moving forward immediately to deliver therapies to the thousands of soldiers who have been wounded in this time of war", Dr. Mikos stated. Mikos, a founding editor of the journal Tissue Engineering and president-elect of the North American Tissue Engineering and Regenerative Medicine International Society, is one of the world's foremost experts on tissue engineering and regenerative medicine.

Technology investigated by the consortium partners in craniofacial reconstruction will include the use of biopolymers as matrices for tissue regeneration and the delivery of different drugs to prevent infection and promote wound healing. Additional tissue-engineering projects that employ adult stem cells to reconstruct lost appendages such as ears and noses will also be investigated.

"We are honoured to be part of this consortium, which will allow us to bring to fruition many years of collaborative research with Rice University and apply novel techniques to aid the reconstruction of devastating facial defects sustained by our military personnel", Dr. Wong stated. Traditionally, it can take years for laboratory breakthroughs to be translated into clinical practice. Dr. Mikos said it is vital for engineers and doctors to work together closely - at every stage of research - if cutting-edge technology is to be quickly transitioned to patients.

Dr. Wong, the director of the UT Dental Branch at Houston's Oral and Maxillofacial Surgery residency training programme, holds surgical appointments at Memorial Hermann Hospital-Texas Medical Center, Lyndon B. Johnson General Hospital, Ben Taub General Hospital and The Methodist Hospital. He said AFIRM's bench-to-bedside research efforts in Houston will help ensure that the technology developed for the military will also benefit civilian victims of trauma.

Dr. Davies stated: "This is the sort of groundbreaking translational research that is being conducted in UT-Houston's new research facility, the Center for Clinical and Translational Sciences, a state-of-the-art clinical research facility funded by one of the first Clinical and Translational Science Awards made by the National Institutes of Health."

The long-standing partnership between Dr. Mikos and Dr. Wong is the foundation for the research. This partnership has been rewarded with several grants from the National Institutes of Health, the Oral and Maxillofacial Surgery Foundation and industry. It has also provided the basis for a joint educational programme combining oral and maxillofacial surgery residency training at UT-Houston with a doctorate in bioengineering at Rice.

Thanks to an existing relationship between the military and the UT Dental Branch's oral and maxillofacial surgery residency programme, the military's own trauma surgeons will get firsthand experience with all the new facial reconstruction techniques developed and tested by AFIRM. Under the residency programme, surgeons from both the Army and Air Force spend time in Houston gaining experience in trauma management.

"We are fortunate to have a close relationship with UT-Houston where we can get experience with wider variety real-world trauma situations, similar to those we would see in Iraq and Afghanistan", stated Capt. Curt Hayes, chief resident of oral and maxillofacial surgery at Lackland Air Force Base's Willford Hall Medical Center in San Antonio. "This new grant presents the opportunity for improving battlefield management and outcome for hard-tissue injuries that are sustained by our military members."

Rice and UT-Houston are two of the 46 member institutions in the Texas Medical Center (TMC), one of the world's largest medical complexes. TMC institutions conduct more than $1 billion worth of research and see more than 5 million patients each year.

"Rice and UT-Houston's AFIRM research programme calls for doctors and bioengineers to work side-by-side to rapidly translate new discoveries from the laboratory to the operating room", stated Rice Provost Eugene Levy. "This is an outstanding example of the kind of joint, tightly interwoven research that will be greatly facilitated and that Rice plans to conduct with UT-Houston and its other TMC partners in the new Collaborative Research Center slated to open in mid-2009." UT-Houston President Dr. James Willerson stated: "This is a most significant endeavour and is a tribute to the strength we can achieve through collaboration in the Texas Medical Center."

A procedure currently performed all over the world for cosmetic purposes might also improve wound healing and limb function for soldiers who are severely hurt and scarred during combat. Dr. Adam Katz, plastic surgeon and researcher at the University of Virginia (UVA) Health System, will conduct research in this area under the Armed Forces Institute of Regenerative Medicine (AFIRM). UVA Health System is part of the Rutgers University and the Cleveland Clinic Consortium.

Dr. Katz, who is the only Virginia doctor to be a part of AFIRM, will study the use of fat grafting for wounds and severe burns to improve their healing and/or to minimize their associated scarring. In one envisioned study, burn patients who have received skin grafts will receive an autologous fat transplant, in which their own fat tissue will be harvested, cleaned, and finally re-injected beneath the skin-grafted area. Dr. Katz believes the skin grafts may heal better with the placement of fat grafts, reducing and/or remodelling scar formation and mitigating scar contractures (tightness) which can limit the motion of limbs.

"Traditionally fat grafting has been used to fill wrinkles or augment lips and other similar structures. More recently, a growing a number of physicians have noticed that fat grafting seems to have beneficial effects on surrounding tissue. Even more, recent published literature suggests that injecting fat around a wound helps it to heal better", stated Dr. Katz. "My goal now is to systematically and rigorously examine the potential effects of fat grafting on wound healing and scarring using controlled, blinded prospective studies to see if an old procedure can be used in a new way."

Dr. Katz's research also has a second component. He will extract and concentrate stem cells from fat tissue and explore their use - with or without biocompatible scaffolds - to engineer new skin or soft tissue to replace damaged dermis and subcutaneous layers of the skin. Dr. Katz believes that when soldiers receive materials made from their own cells, they won't reject the implanted skin or tissue.

"I have read statistics about amputations and have seen the disfiguring scars that our soldiers carry. It's clear that they are surviving more than they did in previous conflicts because of technology and state-of-the-art emergency medical care, but they are experiencing significant morbidities and functional deficits in terms of damaged and/or lost limbs and disfiguring facial trauma that results from explosive devices", Dr. Katz stated. "I feel extremely privileged to be a part of this extensive and concerted effort to improve the lives and futures of our soldiers when they come off the battlefield."

The $85 million in grant money will be awarded over a period of five years beginning in spring/summer of 2008. Approximately 25 percent of the AFIRM's physician researchers are board-certified plastic surgeons - many of whom are American Society of Plastic Surgeons (ASPS) Member Surgeons. Other specialities participating in the AFIRM include, but are not limited to, general surgery, orthopaedics, otolaryngology, and dermatology. According to the Department of Defense, nearly 29.800 soldiers had been wounded in action in the Iraq war as of April 15, 2008 and 1927 wounded in Afghanistan operations as of April 12, 2008.


Leslie Versweyveld

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