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Organ, tissue donor awareness (Baltimore Sun)
Expert advice April is organ and tissue donor awareness month. There are nearly 2,300 people in Maryland who are on the waiting list for an organ or tissue transplant, says Karen Kennedy, director of clinical services at the Living Legacy Foundation of Maryland. These patients are waiting for all kinds of organs, including a heart, lung, kidney and pancreas.

Cleveland Clinic and Rutgers to Lead Newly Formed Institute for War Wounded

Armed Forces Institute for Regenerative Medicine to Develop Therapies for Critically Injured Service Members

CLEVELAND, April 17 /PRNewswire/ -- Cleveland Clinic and Rutgers University are leading one of two civilian research consortia to develop innovative medical therapies for the treatment of wounded service members. Cleveland Clinic will receive more than $10 million from a total of $42.5 million awarded over 5 years to create a new institute called the Armed Forces Institute of Regenerative Medicine (AFIRM).

Cleveland Clinic Orthopedic Surgeon, George Muschler, M.D., is AFIRM's Co-Director, in collaboration with AFIRM Director Joachim Kohn, Ph.D., of Rutgers University. Together Drs. Muschler and Kohn will lead a collaborative network of leading clinician scientists drawn from 15 premier institutions and more than 20 commercial partners nationwide.

"The AFIRM team is deeply committed to offering new recovery options for the brave men and women who have served our country," Dr. Muschler said. "Our collaborative mission is to translate opportunities that are now available in regenerative biology as quickly as possible into practical tools that can be used on the front lines or here at home."

The mission of AFIRM is to accelerate the development of new technologies in the field of regenerative medicine and tissue engineering to effectively serve the needs of injured service members. The research and development of new therapies will focus on the regeneration of bone, muscle, tendon, nerve and blood vessels, as well as new methods for transplantation of limb and facial tissue and the treatment of burns.

Cleveland Clinic President and CEO Delos "Toby" Cosgrove has experienced the devastation of war firsthand and commends the AFIRM project.

"Early in my career, I served as an Air Force surgeon in Vietnam where I saw military casualties firsthand and witnessed the impact of combat injuries on the fine men and women of our Armed Forces," Dr. Cosgrove said. "I am honored that Cleveland Clinic is part of the team awarded this opportunity to serve these heroes and potentially help several thousands of others who suffer from similar injuries."

AFIRM is a national effort to address the healthcare challenges of severely injured service members returning from Afghanistan and Iraq, said Dr. Kohn of Rutgers.

"Our foremost goal is to alleviate the human suffering associated with debilitating blast injuries and to enable our injured men and women to return to productive lives," Dr. Kohn said.

The AFIRM will be a collaborative virtual institution working in conjunction with the US Army Institute of Surgical Research (ISR). A second AFIRM consortium will be managed by Wake Forest University Baptist Medical Center and the University of Pittsburgh who will receive another $42.5 million in funding.

Successful inter-institutional and commercial partnerships like AFIRM have become a hallmark of biotechnology in Ohio, thanks to investments made by the Ohio's Third Frontier Project (TFP), which is working to expand biotech research and business in the state. In 2005 the state initiative funded the Clinical Tissue Engineering Center (CTEC), a collaboration among Cleveland Clinic, Case Western Reserve University, University Hospitals Case Medical Center (who are also part of the Rutgers-Cleveland Clinic AFIRM team) and several other Ohio institutions and companies.

CTEC is a key partner in the larger National Center for Regenerative Medicine (NCRM), which integrates several regional programs and an international education effort focused on the development of therapies based on non-embryonic stem cells and regenerative medicine strategies.

Regenerative medicine in Ohio enjoys broad support from Ohio Governor Ted Strickland and federal government officials, including Ohio Senators George Voinovich and Sherrod Brown, Congresswoman Stephanie Tubbs Jones, and Congressman Ralph Regula.

"This extraordinary grant is a testament to the outstanding work being conducted among the partners and the Department of Defense's recognition of this work," Congressman Regula said. "I am pleased to have been an early supporter of this initiative, as I believe it will profoundly improve the lives of our service members and their families."

The core academic partners in the Rutgers-Cleveland Clinic consortium are: Case Western Reserve University, Carnegie Mellon University, Stony Brook University, Dartmouth College, MIT, Massachusetts General Hospital/Harvard Medical School, Mayo Clinic, Northwestern University, University Hospitals Case Medical Center, University of Cincinnati, University of Medicine and Dentistry of New Jersey, University of Pennsylvania, University of Virginia and Vanderbilt University.

About Cleveland Clinic

Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Approximately 1,800 full-time salaried physicians and researchers at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2007, there were 3.5 million outpatient visits to Cleveland Clinic and 50,455 hospital admissions. Patients came for treatment from every state and from more than 80 countries. Cleveland Clinic's Web site address is www.clevelandclinic.org .

First Call Analyst:
FCMN Contact:

Source: Cleveland Clinic

CONTACT: Scott Heasley, +1-216-444-0141, heasles@ccf.org, or Erinne
Dyer, +1-216-444-8168, dyere@ccf.org, both of Cleveland Clinic

Web site:

http://www.clevelandclinic.org/

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Profile: Transplant News

Organogenesis, Inc. to Develop Regenerative Medicine Therapies for U.S. Military Battlefield Injuries

Consortium Wins Grant to Form New Armed Forces Institute of Regenerative Medicine (AFIRM)

CANTON, Mass. and WASHINGTON, April 17 /PRNewswire/ -- Organogenesis, Inc., the world's most successful regenerative medicine company, announced today that it is part of a consortium -- spearheaded by the Institute for Regenerative Medicine at Wake Forest University Baptist Medical Center -- which has been awarded $42.5 million over five years by the U.S. Army Institute of Surgical Research (ISR) to co-lead one of two academic groups that will form the Armed Forces Institute of Regenerative Medicine (AFIRM).

The collaboration will be headed by the Wake Forest Institute for Regenerative Medicine, and the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. A second consortium will be managed by Rutgers and the Cleveland Clinic.

The two consortiums, working with the ISR, will use the science of regenerative medicine to develop new treatments for wounded soldiers.

"We are proud that Organogenesis will play a key role in the development of better treatments of battlefield injuries through the use of regenerative medicine," said Geoff Mackay, CEO of Organogenesis. "We believe that our experience as pioneers in the translation of regenerative medicine technology from visionary science and laboratory research, to therapies used to benefit patients in everyday medical care, will be important to AFIRM."

AFIRM 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. In addition to developing clinical treatments, 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. Therapies developed by AFIRM will also benefit people in the civilian population with burns or severe trauma.

In addition to its clinical research activities, the AFIRM will create cooperative partnerships with industry to ensure that the technical innovations emerging from the research will transition rapidly into militarily relevant therapies and result in producible technologies, and ultimately will be translated into civilian population applications as well. The AFIRM will incorporate a close integration between basic science research and translational and clinical research in order to bring to practice effective regenerative medicine therapies.

The Wake Forest-University of Pittsburgh team has committed to develop clinical therapies over the next five years that will focus 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

Collaborators for the Wake Forest-McGowan team include Organogenesis, Inc., Tufts University, Allegheny Singer Research Institute, the California Institute of Technology, Carnegie Mellon University, Georgia Institute of Technology, Intercytex, North Carolina State University, Oregon Medical Laser Center at Providence St. Vincent Medical Center, Pittsburgh Tissue Engineering Initiative, Rice University, the Stanford University School of Medicine, the University of California, Santa Barbara, the University of North Carolina, the University of Texas Health Science Center at Houston, the University of Wisconsin, and Vanderbilt University.

More than 50 technologies from the AFIRM team already have had a wide impact on treatments for illness and injury. Researchers 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.

For instance, Organogenesis is the first company to successfully mass produce living regenerative medicine products -- reaching hundreds of thousands of patients in the U.S. and other markets across the world. Its signature product, Apligraf(R), is the first bio-engineered living cell therapy to have received FDA approvals to close diabetic foot ulcers and venous leg ulcers.

Government sponsors of AFIRM are the U.S. Army Medical Research and Materiel Command, the Office of Naval Research, the U.S. Air Force Office of the Surgeon General, the Department of Veterans Affairs and the National Institutes of Health. In addition to this funding, Wake Forest and its partners will provide more than $150 million from academic institutions, industry and state and federal agencies for the projects -- for a total of almost $200 million available for soldier regeneration research.

About Regenerative Medicine

A new frontier in healthcare, regenerative medicine utilizes living human cells, including stem cells, to repair or replace body tissue damaged by injury, disease or even the natural aging process.

Regenerative medicine is a multidisciplinary field which brings together biology, medicine, and engineering to empower scientists to grow living cells, tissues and organs in the laboratory, and to safely implant them into the human body for the purposes of healing.

About Organogenesis, Inc.

Massachusetts based Organogenesis, Inc. is the world's most successful regenerative medicine company and is focused in areas of bio-active wound healing, bio-surgery and bio-aesthetics. Organogenesis delivers living tissue "on demand," and its mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care.

Organogenesis is in the midst of a large expansion, both in the U.S., as well as overseas. As the world's leading Regenerative Medicine company, Organogenesis has broadened its international scope and ties over the past few years. The company has recently established European headquarters located in Switzerland. In addition, last December the company announced an agreement with China's National Tissue Engineering Center (NTEC), a leading stem cell and regenerative medicine consortium, headquartered in Shanghai, for the commercialization of Organogenesis, Inc. technology within the Chinese market, and potentially throughout Asia. For more information, visit http://www.organogenesis.com/.

First Call Analyst:
FCMN Contact:

Source: Organogenesis, Inc.

CONTACT: Angelyn Lowe of Chase Communications, +1-858-273-1805,
alowe@chasepr.com, for Organogenesis, Inc.

Web site:

http://www.organogenesis.com/

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Plastic Surgeons Play Pivotal Role in War Injury Research

$85 Million in Federal Funds Awarded to Reconstruct Devastating Injuries; Not all about Facelifts and Liposuction

ARLINGTON HEIGHTS, Ill., April 17 /PRNewswire-USNewswire/ -- Members of the American Society of Plastic Surgeons (ASPS) will play a pivotal role over the next five years developing groundbreaking therapies to better treat U.S. soldiers critically injured in Iraq and Afghanistan. The U.S. Department of Defense (DoD) has awarded $85 million in grant funding to the Armed Forces Institute of Regenerative Medicine (AFIRM), a multi-institutional network of plastic surgeons and other physicians who specialize in tissue engineering and regenerative medicine. An announcement made today at the Pentagon stated the grant will be used for pioneering medical research and innovations to repair battlefield injuries.

"Reconstructive plastic surgery is critical in treating wounded soldiers and the types of injuries sustained on the battlefield," said Richard D'Amico, MD, ASPS president. "Blast injuries from roadside bombs and high velocity guns are common and affect almost every part of the body. Plastic surgeons are uniquely qualified to perform reconstructive surgery on all areas of the body."

The federally funded research will involve investigating surgical innovations to improve wound healing and tissue repair through adult stem cell and other technologies that will allow new bone, skin, nerves, tendons, muscles, and blood vessels to form. Much of this research is related to the specialty of plastic surgery. The five major areas of research include limb salvage, reconstruction, regeneration, and transplantation; craniofacial reconstruction; burn repair; scar reduction; and treatment for compartment syndrome.

"This funding will serve as a vital step toward improving treatments for devastating injuries to the lower and upper extremities as well as the face," said ASPS Member Surgeon and AFIRM physician Joseph Rosen, MD. "We are proud to serve the troops and hope this research will help them to better heal both physically and emotionally, provide a faster return to productive life, and improve their quality of life after injury. The therapies developed will also serve trauma and burn patients in the general public."

The AFIRM is managed and funding is provided by the U.S. Army Medical Research and Material Command, with additional funding from the U.S. Navy, U.S. Air Force, the National Institutes of Health, and the Veterans Administration. 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 ASPS Member Surgeons. Other specialties participating in the AFIRM include, but are not limited to, general surgery, orthopedics, otolaryngology, and dermatology.

"War has inspired great advances in plastic surgery to correct the awful injuries that are inflicted on its participants," said Dr. D'Amico. "In fact, it was the 'War to End All Wars,' World War I, that challenged plastic surgeons to achieve groundbreaking advances in wound repair and reconstruction. With this latest conflict in Iraq and Afghanistan, plastic surgery, once again, is integral to saving and restoring soldiers' lives."

According to the DoD, nearly 29,800 soldiers had been wounded in action in the Iraq war as of April 15, 2008 and 1,927 wounded in Afghanistan operations as of April 12, 2008.

Visit http://www.plasticsurgery.org/ for referrals to ASPS Member Surgeons and to learn more about cosmetic and reconstructive plastic surgery.

The American Society of Plastic Surgeons is the largest organization of board-certified plastic surgeons in the world. Representing more than 6,700 physician members, the Society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises more than 90 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the Society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada.

Editor's Note: ASPS Member Surgeons participating in the AFIRM research
are available for media interviews.
First Call Analyst:
FCMN Contact:

Source: American Society of Plastic Surgeons

CONTACT: ASPS Public Relations, +1-847-228-9900,
media@plasticsurgery.org

Web Site:

http://www.plasticsurgery.org/

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Profile: Transplant News

Beaumont Sees Results in Nation's 1st Urinary Nerve Rewiring Surgeries for Spina Bifida Patients

ROYAL OAK, Mich., April 17 /PRNewswire-USNewswire/ -- Seven children from across the United States are gaining bladder control through a revolutionary, first-in-the-nation nerve rerouting surgery for patients with spina bifida. The surgeries were conducted in 2007 at Beaumont Hospital in Royal Oak, Mich.

The children previously required the insertion of a catheter to empty their bladder or endured significant incontinence. But as a result of the surgery, they are beginning to void on their own and are also seeing improvement in bowel function. Initially they signaled the bladder to urinate by scratching or pinching their leg or buttocks. But, remarkably, in most patients, the brain was able to take over and control urination normally.

This will allow them to attend school without being catheterized and to play with other children without the embarrassment of soiling themselves. It also means fewer urinary tract infections resulting from catheterization, and reduces their need for antibiotics for infection control.

"These are still considered early results but we are excited to see them," says Kenneth Peters, M.D., chairman of the Urology department at Beaumont, Royal Oak. "It's still too early to see results on the two adult patients with spinal cord injuries who also had the surgery."

Results of Dr. Peters' research on nerve rerouting surgery are to be presented in May at the American Urological Association annual meeting.

Local philanthropists J. Peter and Florine Ministrelli of West Bloomfield, Mich. underwrote the cost of the surgeries. They have also funded the Ministrelli Program for Urology Research and Education at Beaumont, which enables Beaumont to continue its leadership through the purchase of equipment, the expansion of education and research efforts and bringing innovative treatments to patients.

In spinal cord injury and spina bifida, the nerves that control the bladder and sphincter are damaged. People cannot urinate without the use of a catheter or are constantly wet. Most experience recurrent urinary tract infections. Also, backup of urine into the kidneys can damage these delicate organs. As a result, kidney dialysis or transplant may be required.

The research at Beaumont uses a spinal surgery pioneered in China to redirect nerves from the leg to the bladder to gain better control of urination. Beaumont is the only U.S. hospital performing this surgery, and patients have traveled from as far as Utah and Pennsylvania to have it. The Chinese doctor who developed the surgery, Chuan-Guo Xiao, M.D., reports an almost 90-percent success rate and an average time for results of 12-24 months after surgery.

"In a stunning reversal of the exchange of information and technology, which typically originates in the United States and is exported to countries like China, we are able to offer these patients urinary function and dramatically improved their quality of life," says Dr. Peters. "We are grateful to Dr. Xiao and to the patients in this study who are truly medical pioneers."

Possible side effects of the surgery include mild postoperative spinal fluid leakage, lower extremity weakness and headache. Recent changes in the surgical technique have dramatically decreased the incidence of these complications. Standard risks associated with any surgery may include bleeding and infection.

The surgical team that worked with Dr. Peters at Beaumont includes Dr. Xiao; Ananias Diokno, M.D., Beaumont Hospitals' chief medical officer; and urologist Jose Gonzalez, M.D.

"Nerve rerouting is an example of Beaumont's leadership in translational research that applies research results to clinical care that is life changing for our patients," says Dr. Diokno.

Call study coordinator Cindy Turzewski, R.N., at 248-551-3355 or e-mail her at Cynthia.turzewski@beaumont.edu, for more information on the nerve rerouting research.

Beaumont's 1,061-bed hospital in Royal Oak is a major academic, research and referral center with Level I trauma designation. It ranks first in the United States for inpatient admissions and second for surgical volume. Beaumont, Royal Oak is named in nine medical specialties on the U.S. News & World Report's "America's Best Hospitals" list, ranking 31st as a top hospital for urology. Visit Beaumont's Web site at www.beaumonthospitals.com.

First Call Analyst:
FCMN Contact:

Source: William Beaumont Hospital

CONTACT: Cindy Turzewski, R.N. of William Beaumont Hospital,
+1-248-551-3355, Cynthia.turzewski@beaumont.edu

Web Site:

http://www.beaumonthospitals.com/

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Profile: Transplant News

FEATURED. Children’s Performs First Intestinal Transplant in Pacific Northwest; Seattle Times: 8-Year-Old Boy Gets Rare Intestine Transplant; Gifts of Life: [continued]

AlphaVax Announces Initial Analysis of Data From CMV Phase 1 Clinical Trial

RESEARCH TRIANGLE PARK, N.C., April 17 /PRNewswire/ -- AlphaVax, Inc. announced today an initial analysis of data from a Phase I clinical trial of a cytomegalovirus (CMV) vaccine that is based on its platform alphavirus replicon vector technology.

The trial is a placebo-controlled, randomized, double-blind, single center study involving 40 healthy, 18-40 year old, CMV-negative volunteers. The trial is being conducted by David I. Bernstein, M.D., Director of Infectious Diseases at the Cincinnati Children's Hospital Medical Center in Ohio. AlphaVax's CMV vaccine was administered three times over six months at one of two dosage levels, and safety and immunogenicity data were obtained from all volunteers following each dose of the vaccine. Confirming AlphaVax's earlier reported experience in humans with its prototype HIV and influenza vaccine candidates, the CMV vaccine has proven to be safe and very well tolerated. While the study remains blinded, it is clear that a majority of the subjects developed substantial antibody or T cell responses to all three CMV antigens in the vaccine. Preliminary results suggest that both the CD4 and CD8 cells appear to be multifunctional T cells, similar to the type that has recently been associated with protective responses.

"We are very pleased with these results as they clearly demonstrate the vaccine's ability to stimulate readily detectable immune responses to all three vaccine-expressed antigens and at both dosage levels. It is these types of responses, both cellular and humoral, that will be required for an effective vaccine against CMV infection and disease," said Dr. Robert Olmsted, Vice President of Research.

The vaccine used in this trial is bivalent as it contains two replicon vectors which are derived from an attenuated alphavirus. One replicon vector expresses the pp65 and IE1 genes of CMV and the second the CMV gB glycoprotein gene. Virus-like particles containing the replicon vectors were produced in cell culture, harvested and administered to the volunteers at two dosage levels. A key design and safety feature of this single-cycle vaccine technology is that there is no further replication of the virus-like particles after the expression of the CMV proteins in the vaccine recipients.

About CMV

CMV is a herpesvirus that is a major cause of morbidity and mortality in congenitally infected infants and hematopoietic stem cell (HSCT) and solid organ transplant (SOT) recipients. Congenitally acquired CMV, the most common congenital infection in the United States, causes occasional mortality and significant morbidity in infants and young children (e.g., hearing loss and mental retardation). For healthy people who acquire CMV after the prenatal period, infection is life-long but typically asymptomatic. However, CMV reactivation or primary infection in HSCT and SOT recipients with suppressed or impaired immune systems can be life-threatening. In these patients, CMV infection is a major cause of disease, organ rejection, and death, with mortality rates among infected HSCT patients of 50% despite current anti-CMV drugs. Manifestations of CMV include pneumonia, hepatitis and gastrointestinal disease, usually occurring within the first 100 days after transplant.

About AlphaVax

AlphaVax, Inc. is a North Carolina-based, clinical-stage company that uses a novel alphavirus vector platform technology that has proven to be highly flexible and immunogenic, and allows the same manufacturing, formulation, and delivery strategies to be applied to many different products. The company employs staff with expertise spanning vaccine design, process development, GMP manufacturing, quality assurance, and regulatory and clinical affairs. In addition to cytomegalovirus, important disease targets include influenza, cancer, HSV, RSV, and a number of biodefense vaccine products. The AlphaVax headquarters and R&D facilities are located in Research Triangle Park, and its GMP manufacturing facility is located in Lenoir, NC.

First Call Analyst:
FCMN Contact:

Source: AlphaVax, Inc.

CONTACT: Dr. Robert Olmsted of AlphaVax, Inc., +1-919-595-0323

Web site:

http://www.alphavax.com/

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Profile: Transplant News

NTSB to discuss fatal transplant plane crash (WBAY Green Bay)
Associated Press - April 16, 2008 5:15 PM ET MILWAUKEE (AP) - It could be months before it's known what caused a medical transplant team's plane to crash last year in Lake Michigan.

Immune Function in Adult Heart Transplant Patients Reflects Risk for Organ Rejection and Infection (PR Newswire via Yahoo! Finance)
Results of an analysis of three years of data on the monitoring of cell-mediated immunity in adult patients undergoing heart transplantation at the University of California at Los Angeles Health System have demonstrated that ImmuKnow® values appear to closely reflect the immune function of the transplant recipient and patient risk for organ rejection and/or infection.