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Although there is currently no stem cellbased treatment for diseases of the 1) ___ system, the field has moved much closer to making this goal a reality. Progress has been driven by major jumps in our understanding of how neuronal subtypes and glia develop in vivo and in vitro. Further research will inform our ability to coax endogenous 2) ___ ___ in the adult nervous system to respond to injury and to transplant the correct type of cell to ameliorate different types of diseases. Just as important, the ability to differentiate subtypes of neurons and glia from embryonic stem cells (ESCs) will allow drug screens to identify neuroprotective drugs, which are currently unavailable. The types of nervous system 3) ___ that represent the best targets for stem cellbased therapies are those that would be improved by the transplant or induced replacement of a limited number of cell types. Parkinsons disease, sensory disorders, and glial diseases fall into this category and could potentially be cured by a cell-replacement therapy. Motor system disorders and spinal cord injuries are more complex, but given their severity and lack of current treatment options, it can be argued that any improvement in function would be of great benefit. There are nervous system disorders that do not currently make good targets for cell 4) ___ therapies because the associated neurodegeneration is too widespread and diffuse. Alzheimers disease is one example, and it is unlikely to be ameliorated by adding more cells to the system. However, Alzheimers research could benefit enormously from disease-specific 5) ___ lines that could be used to study the degeneration of neurons in vitro. The prospect of using stem cells to intervene in 6) ___ disease is promising, but given the complexities of the nervous system, progress will likely continue in measured steps. To move the research toward useful therapies, it is critical that the efficacy of any experiment involving human subjects, and even experiments involving animal procedures, be performed using a double-blind placebo-controlled method. Certainly this increases the cost and the labor of an experiment, but the cost of doing research that is merely tantalizing and not conclusive, or worse, research that raises false hopes, is much higher. When there is a lack of rigorous controls, it is easy to falsely attribute an observed improvement to an incorrect cause. Finally, it is important to have scientific meetings to communicate both positive and negative results, as well as successes and cautionary tales. Despite the 7) ___ differences between neurodegenerative diseases, their eventual stem cell therapies will likely share many features; Information gleaned in one field can drive forward progress in the others..

ANSWERS: 1) nervous; 2) stem cells; 3) diseases; 4) replacement; 5) ESC; 6) neurodegenerative; 7) molecular

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Embryonic stem cells seen pictured through a microscope viewfinder in a laboratory.

LONDON, England (CNN), December 23, 2008 — As well as their potential for creating effective therapies for debilitating diseases, embryonic stem cells could open the door to improved pharmaceutical drug testing, according to a leading British stem cell researcher.

Speaking at a recent meeting of the British Pharmacological Society in Brighton, UK, Christine Mummery described how using embryonic stem cells to create human heart cells could be a viable and scientifically exciting alternative to animal testing.

Mummery, a Professor of Developmental Biology at Leiden University Medical Center in The Netherlands told CNN: “It could save a lot of time and effort of taking the wrong drugs through, or it may allow drugs through which are lost at an early stage, because they affect the animal cells but don’t have an effect on human cells.

“It may also allow more and better drugs to come through the first tests or flag up safety issues at an earlier stage.”

Drug development is an incredibly expensive and protracted process. Typically, it costs around $1 billion to bring a new drug to market and the whole process usually takes about ten years.

Before new drugs can go forward for clinical trials, it’s necessary for the chemical compounds which make up a drug to undergo thousands of tests for toxicity before beginning trials on animals — initially on rodents and then often on dogs.

It’s here, at this ethically sensitive stage, that Professor Mummery believes stem cell research could transform drug development.

“Many drugs are designed to affect the heart deliberately, controlling beats and rates of contraction,” said Mummery, who specializes in converting embryonic stem cells into cardiac and vascular cells.

But, as she points out, plenty of drugs designed to treat other complaints can also have negative side effects on the heart — the painkiller Vioxx being a notable example.

“It’s really important for the pharmaceutical industry to have proper test systems to pick those sorts of things up,” she said.

Merck & Co withdrew Vioxx in 2004 because of concerns over increased risk of stroke and heart attacks. Lawsuits filed against the company have cost them billions of dollars and many litigants still await their day in court.

Stem cell based drug testing is already being promoted in the UK with the public/private initiative “Stem Cells for Safer Medicine” which was set up in 2007.

It’s something Mummery hopes will be replicated in other countries and particularly in the U.S. under President-elect Obama who is a proponent of stem cell research.

A 2007 sabbatical at the Harvard Stem Cell Institute in Cambridge, Massachusetts gave Mummery first-hand experience of the ethical debates that have engulfed stem cell research debates in the U.S..

“I was shocked at the light years we are away from the way people think about embryonic stem cells in the States,” she said. “It’s very mixed up with the abortion issue. It’s put into the same category.”

Public funding, or the lack of it, under President George W. Bush has also stymied research.

“What’s happened in the U.S. is that people have become very frustrated and a lot of private initiatives — like the Harvard Stem Cell Institute — were started up to circumvent the lack of National Institutes of Health (NIH) funding. NIH researchers are either left behind or have a huge administrative burden,” Mummery said.

“You go into a lab in the States and they say; ‘this is our NIH lab, and this is our other lab’. They have to buy one microscope to look at NIH lines and another to look at other lines. They have to administer all the stem cells separately. There are even dotted lines in a lab which you can and cannot cross. It’s completely ridiculous,” she said.

Drug company interest in stem cell drug testing was demonstrated in July 2008, when GlaxoSmithKline entered into a $25 million-plus agreement with the Harvard Stem Cell Institute.

Commenting on the deal, Professor Patrick Vallance, Head of Drug Discovery at GSK said: “GSK believes stem cell science has great potential to aid the discovery of new medicines by improving the screening, identification and development of new compounds.”

Drug testing is an emotive subject not least because of animal testing. So how have anti-vivisectionists greeted the news?

Chief Executive at the British Union for the Abolition of Vivisection (BUAV), Michelle Thew told CNN: “We have some concerns about the technology in general because it will still use animal cells and animals, but we are positive about things which may reduce the numbers of live animals in testing.”

Clearly, the BUAV would like to do away with all animal testing altogether. Their obvious ethical objections, are backed up by questions about its efficacy.

“One of issues with drug development,” Thew said, “is that animal testing is not very successful at getting drugs through the process because a lot of the tests aren’t very predictive. They are also very expensive and time-consuming.”

Even if stem cell drug testing does mark the beginning of the end for animal testing, the ethical vacuum is already being filled by another storm of controversy surrounding the use of embryonic stem cells.

But, as Mummery points out, these objections will disappear should researchers from Japan and the U.S. continue to improve on early successes in creating stem cells from skin cells.

Whatever the debate, the fact is at the moment, says Mummery, there are very few new drugs coming on to the market in the European Union. “The drug companies are very nervous about the costs involved and the risks,” she said.

“If there was a reliable system to flag up issues they would be much more confident of taking drugs through to market.”


via videosift.com

MAJ Christopher Todd

Blast injuries form the basis for most of our casualties in the wars in Iraq and Afghanistan. While advances in body armor have exponentially improved levels of torso and head protection, extremities and exposed areas of the body remain largely vulnerable to the effects of improvised explosive devices and other battlefield explosives. As a result, injuries such as burns, soft tissue damage, compartment syndrome, and amputations are seen. Regenerative medicine shows exceptional promise in developing therapies to address these types of injuries.

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U.S. Army Surgeon General LTG Eric Schoomaker explains how researchers are growing a new ear for a badly burned Marine using stem cells from his own body. This is one area of advanced treatment being explored by AFIRM. (DOD photo by R.D. Ward.)

Regenerative medicine focuses on the treatment of tissue and organ injuries by using the body’s regenerative capability and cell integration with other biological materials to synthesize or “grow” tissues and organs to replace the damaged ones. Because of recent advances in regenerative medicine, AFIRM was formed in a collaborative effort among the U.S. Army Medical Research and Materiel Command (USAMRMC), the Office of Naval Research (ONR), the U.S. Air Force (USAF) Office of the Surgeon General, the National Institutes of Health (NIH), and the Department of Veterans Affairs (DVA).

AFIRM is a partnership that involves government, academia, and industry in achieving rapid advances in regenerative medicine to address combat injuries. AFIRM is not a “brick and mortar” institution, but rather a virtual organization of nongovernment research partners and the U.S. Army Institute for Surgical Research in San Antonio, TX, working in concert to achieve objectives in regenerative medicine. Eventually, the therapies developed and enhanced by AFIRM will also be translatable into viable treatments for the civilian population.

AFIRM’s Formation
A typical partnership between the government and outside entities normally forms around a contract. However, 10 United States Code 2358 authorizes DOD to conduct research and to enter relationships with external parties through grants and cooperative agreements, known collectively as assistance agreements. Unlike contracts, assistance agreements usually do not require the production of deliverables as a condition for receiving government funding.

Assistance agreements usually support defined research goals and objectives, but without guaranteed results. Moreover, DOD’s assistance agreements must be militarily relevant while supporting a public purpose. Each grant and cooperative agreement has different government involvement. Grants do not see much government involvement, while, as the name implies, cooperative agreements significantly involve the government in the research portion. Additionally, like contracts, assistance agreements are often awarded on a competitive basis. In lieu of a Request for Proposal, DOD will synopsize its research needs through Broad Agency Announcements or more specific Program Announcements (PAs).

AFIRM is a partnership that involves government, academia, and industry in achieving rapid advances in regenerative medicine to address combat injuries.

AFIRM was created on the award of cooperative agreements. COL Robert Vandre, USAMRMC’s Director of Combat Casualty Care Research, initially brought forward the AFIRM idea and sought funding partners with ONR, NIH, the USAF, and DVA. From this, USAMRMC approached its contracting arm, the U.S. Army Medical Research Acquisition Activity (USAMRAA), to solicit extra government interest in AFIRM. Like contracts, the authority to award assistance agreements is limited to those possessing a warrant. Gilbert Hovermale, a veteran of the acquisition workforce and one of USAMRAA’s warranted Grants Officers, issued a Request for Information (RFI) in January 2007 to determine the AFIRM interest level in academia and industry.

The RFI generated 28 responses from parties potentially interested in the AFIRM concept. These respondents, along with the sponsors, formed a community of interest in furthering the AFIRM concept by permitting idea sharing about regenerative research. As research began, USAMRAA issued a PA to further refine and target these research ideas. The PA elicited 14 proposals from parties potentially interested in the AFIRM. Eventually, the AFIRM’s direction was defined enough to issue the formal PA in August 2007.

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The Wake Forest Institute for Regenerative Medicine’s AFIRM research program has developed a way to grow living cartilage tissue on a synthetic ear-shaped implant (shown in the bottom image) in the laboratory. The microscopic view (shown in the top image) shows the interface between the implant (white) and the cartilage tissue (pink). (Photo courtesy of the Wake Forest Institute for Regenerative Medicine.)

The PA resulted in seven full proposal submissions for USAMRAA evaluation. To facilitate evaluation, two panels were established. The Peer Review Board, staffed by scientific experts in research, was responsible for proposal technical evaluation and for screening them for scientific merit to determine which proposal had the highest likelihood for rapid success. The Program Review Board, made up of sponsor representatives, was charged with making a funding recommendation to the Grants Officer.

The proposal evaluation process was accomplished in three phases, which were designed to select the proposal with the highest probability of generating advances in regenerative medicine that would quickly translate into viable treatments for wounded warfighters. The first phase was an initial screening of the proposal by the Grants Officer and the Peer Review Board Chair to determine the responsiveness to the PA’s terms and criteria. Five proposals were found to be generally responsive and went to the second evaluation phase.

The second phase was a full evaluation of written proposals by the Peer Review Board. As a result, two institutions were invited to the final phase of oral presentations in front of the Peer Review Board. After this final phase, the results and recommendations from the technical review were forwarded to the Program Review Board to make a final recommendation to the Grants Officer. During this programmatic review, the White House became aware of AFIRM and matched the original sponsor funding, bringing the federal funding available from $42.6 million to $85.2 million over a 5-year period.

Because of this increase in funding and the complementary nature of the two final proposals, the Program Review Board made an unconditional recommendation for two separate awards for the finalists. On Feb. 15, 2008, with the assistance of AFIRM Project Contract Specialist Susan Dellinger, the Grants Officer awarded Wake Forest University and Rutgers, the State University of New Jersey, for AFIRM research. These two universities will employ a multi-institutional base of academic and industry partners to accomplish the work under AFIRM. The recipients, along with respective nonfederal partner organizations, are also contributing funding to the AFIRM. The combined AFIRM budget is expected to exceed $250 million from all federal and nonfederal contributors.

The AFIRM process shows how DOD can partner with academia and industry quickly and successfully to achieve substantial improvements in military readiness.

AFIRM’s Future Capabilities
Because of AFIRM’s collaborative nature and the expected free flow of research information among participants, process managers will continually face various confidentiality and intellectual property rights during the agreements. Nonetheless, this symbiotic relationship will greatly enhance the speed in achieving research objectives. Accordingly, AFIRM is expected to make substantial gains in regenerative medicine within 1 to 2 years of its inception.

The AFIRM process shows how DOD can partner with academia and industry quickly and successfully to achieve substantial improvements in military readiness. Through participation from industry and academia, the sponsors’ exceptional foresight, and hard work from our acquisition professionals, AFIRM will soon be providing a foundation to greatly improve the medical care provided to our wounded service members.

MAJ CHRISTOPHER TODD is an Army Medical Department Military Acquisition Intern. He holds a B.S. in political science from Texas A&M University, an M.A. in management from Webster University, and an M.S. in logistics management from the Florida Institute of Technology.

By Gerry J. Gilmore
American Forces Press Service

WASHINGTON, April 17, 2008 – The Defense Department today launched a five-year, Army-led cooperative effort to leverage cutting-edge medical technology to develop new ways to assist servicemembers who’ve suffered severe, disfiguring wounds during their wartime service.

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U.S. Army Surgeon General Lt. Gen. Eric Schoomaker explains, during an April 17, 2008 Pentagon press conference, how researchers are growing a new ear for a badly burned Marine using stem cells from his own body. This is one area of advanced treatment being explored by the new Armed Forces Institute of Regenerative Medicine. Defense Dept. photo by R. D. Ward
(Click photo for screen-resolution image);high-resolution image available.

The newly established Armed Forces Institute of Regenerative Medicine, known by the acronym AFIRM, will serve as the military’s operational agency for the effort, Dr. S. Ward Casscells, the assistant secretary of defense for health affairs, told reporters at a Pentagon news conference.

A key component of the initiative is to harness stem cell research and technology in finding innovative ways to use a patient’s natural cellular structure to reconstruct new skin, muscles and tendons, and even ears, noses and fingers, Casscells said.

Just more than 900 U.S. servicemembers have undergone amputations of some kind due to injuries suffered in wartime service in Afghanistan or Iraq, Casscells said. Other troops have been badly burned or suffered spinal cord injuries or significant vision loss.

“Getting these people up to where they are functioning and reintegrated, employed, (and) able to help their families and be fully participating members of society” is the task at hand in which AFIRM will play a major role, Casscells said.

AFIRM will fall under the auspices of the U.S. Army Medical Research and Material Command, based at Fort Detrick, Md., and it also will work in conjunction with U.S. Army Institute of Surgical Research, in San Antonio.

The Medical Research and Material Command is the Army’s lead medical research, development and related-material acquisition agency. It comes under U.S. Army Medical Command, which is led by Lt. Gen. Eric B. Schoomaker, the Army’s surgeon general. Schoomaker accompanied Casscells at the news conference.

“The cells that we’re talking about actually exist in our bodies today,” Schoomaker pointed out. “We, even as adults, possess in our bodies small quantities of cells which have the potential, under the right kind of stimulation, to become any one of a number of different kinds of cells.

For example, Schoomaker said, the human body routinely regenerates bone marrow or liver cells.

AFIRM will have an overall budget of about $250 million for the initial five-year period, of which about $80 million will be provided by the Defense Department, Schoomaker said. Other program funding will be provided by the National Institutes of Health, in Bethesda, Md., the Department of Veterans Affairs, and local public and private matching funding.

Rutgers University, in N.J.; Wake Forest University, in N.C.; and the University of Pittsburgh also will participate in the initiative.

Dr. Anthony Atala, a surgeon and director of the Institute for Regenerative Medicine at Wake Forest, also attended the news conference. Atala’s current research keys on growing new human cells and tissue.

“All the parts of your body, tissues and organs, have a natural repository of cells that are ready to replicate when an injury occurs,” Atala told reporters.

Medical technicians now can select cells from human donors and, through a series of scientific processes, can “regrow” new tissue, Atala said.

“Then, you can plant that (regenerated tissue) back into the same patient, thus avoiding rejection,” Atala said.

Special techniques are being developed to employ regrown tissue in the fabrication of new muscles and tendons, Atala observed, or for the repair/replacement of damaged or missing extremities such as noses, ears and fingers.

Continued advancement in regenerative medicine would greatly benefit those servicemembers and veterans who’ve been severely scarred by war, Schoomaker said.

The three-star general cited animals like salamanders that can regrow lost tails or limbs. “Why can’t a mammal do the same thing?” he asked.

1077E886-0A31-4C22-BBE3-741A66D6578D.jpgAssistant Secretary of Defense for Health Affairs Dr. S. Ward Cassells opens a Pentagon press conference, April 17, 2008, held to announce the founding of the Armed Forces Institute of Regenerative Medicine (AFRM). This multi-institutional, interdisciplinary network will utilize the latest technologies in stem cell research to develop advanced treatment options for our severely wounded military personnel. DoD photo by R. D. Ward

genesis, Inc. to Develop Regenerative Medicine Therapies for U.S. Mi

ORLANDO, Florida (CNN) — Regrowing a fingertip cut off in an accident sounds like something from a futuristic movie. But with innovative technology developed by the U.S. Army, such regrowth is possible today.

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This remotely controlled robot, called BEAR, could help remove injured soldiers from battlefields.

This research project and a hundred others were on display this month at the 26th Army Science Convention. Some the greatest minds in science from around the world gathered at the four-day conference to exchange ideas and showcase collaborative projects between the Army’s research laboratories, universities and partner industries.

The main goal is to develop technology to make soldiers safer and more effective, said Thomas H. Killion, the Army’s chief scientist.

The Army’s regenerative medicine study combined properties from the intestinal lining and the urinary bladder to create a regenerative substance called Extracellular Matrix.

The cream-colored crystallized powder, called “magic dust,” boosts the body’s natural tendency to repair itself, said U.S. Army Biological Scientist Sgt. Gen Rossman. When the matrix is applied to a missing digit or limb, “the body thinks it’s back in the womb,” Rossman said.

One civilian participated in the regenerative-medicine study after cutting off the tip of his finger in a model plane’s propeller. Researchers continually applied the matrix to the wound, and after four weeks, the body grew skin and tissue to replenish the damaged area.

The U.S. military branches have begun a consortium with private institutions to develop treatments for severely injured troops. With the help of grants, the Armed Forces Institute of Regenerative Medicine is studying nerve and vein transplantation, treating burns without scarring and regeneration of tissue, skin and even bone.

Through both animal studies and civilian clinical trials, the institute is developing therapies for the large number of soldiers injured by improvised explosive devices and other explosives in Afghanistan and Iraq.

“We are working on trying to regenerate limbs, to repair limbs and to keep them from being amputated,” institute Project Director Col. Bob Vandre said.

Army scientists also have developed an engineered skin substitute made in a laboratory from patients’ own cells. A postage stamp-sized patch of skin could grow several times larger than the original sample. The engineered skin could then be placed over a wound or burn, protecting it from infection, and eventually cover large portions of the body that have been damaged.

“Our goal is to restore the function to our wounded warriors who have given so much in battle,” Vandre said.

Armed Forces Institute scientists also say they also have developed a process to rebuild missing or damaged bone. A web-like tube of calcium-phosphate ceramic, called hydroxyapatite, acts as a biodegradable scaffold that is set in place of the missing bone, giving the body a platform on which to rebuild.

Scientists say the scaffold allows the body to regrow its own natural tissue, bone and veins so it can support itself. Because of the complexity of the process, researchers so far have regrown only 3 centimeters of bone in clinical trials on rats, but they hope to reach 5 centimeters in two years. With the regrown bone, scientists could avoid placing titanium or other medical devices in the body.

Of course, to apply this technology, the Army needs a way to safely remove injured soldiers from combat zones. Enter the Battlefield Extraction Assist Robot, or BEAR, a human-shaped machine with eyes, ears and arms for lifting heavy objects.

Built by Vecna Technologies in association with the Army, BEAR is still a prototype. But its potential is promising. BEAR is outfitted with lights, two cameras and infrared abilities, and it can travel up to 10 mph. The device also can lift 250 pounds while balancing on its toes.

Vecna robotic engineer Andrew Allen says BEAR can be remotely operated, reducing the chance of injuries to soldiers’ human rescuers.

“BEAR can easily be replaced; it costs money and not lives,” Allen said.

Robot technology has exploded in the past six years, said Army scientist John Parmentola. Robot prototypes of all kinds were on display at the conference, and about 10,000 military robots are expected to be deployed in the field in 2009.

Robots can be outfitted to accomplish various tasks. One can detect 38 different chemical or biological explosives from a distance of 3 to 5 meters. The robot could be used to scan car doors or truck lids for explosives or chemical residue.

Another, called Packbot, is deployed in Iraq for surveillance, reconnaissance and explosives removal. Packbot has been outfitted to react to voice commands, given remotely through an earpiece. Loud background noises do not distort the commands, because the system monitors the vibrations of the operator’s jawbone.

Finally, some robots come with a retractable apparatus called a Zipper Mast or Situational Awareness Mast, which can be equipped with a camera or antenna and raised to peer over walls or send radio communications.

The smallest Zipper Mast is not much bigger than a coffee pot and can extend to a height of 8 feet. Designed by the U.S. Army’s Tank Automotive Research, Development and Engineering Center, the larger mast is affixed to tanks and can reach heights over 30 feet.

2008
BY Gerry J. Gilmore, special to Soldiers Magazine

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Army surgeon general Lt. Gen. Eric Schoomaker explains how researchers are growing a new ear for a badly burned Marine using stem cells from his own body. Photo by R.D. Ward

The Defense Department has launched a five-year, Army-led cooperative effort to leverage cutting-edge medical technology to develop new ways to assist servicemembers who’ve suffered severe, disfiguring wounds.

The newly established Armed Forces Institute of Regenerative Medicine, known by the acronym AFIRM, will serve as the military’s operational agency for the effort, Dr. S. Ward Casscells, the assistant secretary of defense for health affairs, told reporters at a Pentagon news conference.

A key component of the initiative is to harness stem-cell research and technology to use a patient’s natural cellular structure to reconstruct new skin, muscles and tendons, and even ears, noses and fingers, Casscells said.

Just more than 900 U.S. service-members have undergone amputations due to injuries suffered in Afghanistan or Iraq, Casscells said. Other troops have been badly burned or suffered spinal-cord injuries or significant vision loss.

“Getting these people up to where they are functioning and reintegrated, employed, able to help their families and be fully participating members of society,” is what AFIRM will help do, Casscells said.

AFIRM will operate under the auspices of the U.S. Army Medical Research and Materiel Command, based at Fort Detrick, Md. It will also work in conjunction with the U.S. Army Institute of Surgical Research, in San Antonio, Texas.

The MRMC is the Army’s lead medical research, development and related materiel-acquisition agency. It falls under U.S. Army Medical Command, which is led by Army surgeon general Lt. Gen. Eric B. Schoomaker.

“The cells that we’re talking about actually exist in our bodies today,” Schoomaker said. “Even as adults, we possess small quantities of cells which have the potential, under the right kind of stimulation, to become any one of a number of different kinds of cells.”

For example, Schoomaker said, the human body routinely regenerates bone marrow or liver cells.

AFIRM will have an overall budget of about $250 million for the initial five-year period, of which about $80 million will be provided by the Defense Department, Schoomaker said. Other program funding will be provided by the National Institutes of Health, in Bethesda, Md., the Department of Veterans Affairs, and local public and private matching funding.

Rutgers University, Wake Forest University and the University of Pittsburgh will also participate in the initiative.

The research of Dr. Anthony Atala, a surgeon and director of the Institute for Regenerative Medicine at Wake Forest, focuses on growing new human cells and tissue.

“All the parts of your body, tissues and organs, have a natural repository of cells that are ready to replicate when an injury occurs,” Atala said

Medical technicians now can select cells from human donors and, through a series of scientific processes, can “regrow” new tissue, he said.

“Then the regenerated tissue can be planted back into the same patient, thus avoiding rejection,” Atala added.

Special techniques are being developed to employ regrown tissue in the fabrication of new muscles and tendons, or for the repair or replacement of damaged or missing extremities such as noses, ears and fingers.

Continued advancement in regenerative medicine would greatly benefit servicemembers and veterans who have been severely scarred by war, Schoomaker said.

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

Canton, Mass. / Washington D.C.—April 17, 2008—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®, 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 www.organogenesis.com.

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