DoD News Briefing with Dr. S. Ward Casscells and Lt. Gen. Eric Schoomaker at the Pentagon, Arlington, Va.

STAFF: Well, good afternoon and welcome. And thank you for joining us for what, I think, is a very exciting initiative that the department has undertaken with respect to regenerative medicine.

Today, we have a number of people to talk to you about this. Dr. Ward Casscells, the assistant secretary of Defense for Health Affairs, and Lieutenant General Schoomaker, Army surgeon general, are here to announce the creation of a new federally-funded institution, the Armed Forces Regenerative Medicine.

This is an effort to address the unprecedented challenges of caring for servicemembers that are returning from Afghanistan and Iraq with multiple traumatic injuries. And it is an effort that is made up of multi-institutional consortiums.

And so we have a number of individuals joining us from outside the department today from Wake Forest University, University of Pittsburgh and Rutgers University and the Cleveland Clinic -- will all be participating in this. And some of these representatives are even here today.

So welcome and thank you for taking the time to come to the Pentagon also.

And with that, let me go ahead and get Dr. Casscells up here to tell you what this is really about.

DR. CASSCELLS: Thank you, Mr. Whitman.

And thank you for coming.

I'd like to welcome General Dr. Mike Kussman, representing the VA, undersecretary, veterans health care system, as you know, Dr. Kussman, thank you for coming. Thanks for being a great partner in the care of our wounded warriors and in the care of our retirees broadly. It's an honor to work with you.

Dr. Tony Atala, from Wake Forest, a pioneer in this area of tissue reconstruction, using a number of techniques, including stem cell technologies.

And Dr. Joachim Kohn from Rutgers University. Dr. Bob Vandre from the U.S. Army Medical Research Command. (Name inaudible) -- Office of Naval Research.

And particularly Lieutenant General Eric Schoomaker, the Army surgeon general, who will be announcing in a few minutes the launching of the Armed Forces Institute of Regenerative Medicine. And let me say just a little bit about the context, and he'll tell you about what the center will be.

We've had just over 900 people, men, some women, with amputations of some kind or other since the start of the conflicts in Afghanistan and Iraq. We've had a large number of burns. We've had a couple hundred people with spinal cord injuries and\or significant vision loss.

And getting these people up to where they are functioning and reintegrated, employed, able to help their families and be fully participating members of society -- this is our task.

And as those of you know, most of you have covered the military for some time. You know the military health system. We focus on what we can do today and what we can do now, and not so much on the research that's going to bear fruit in 10 or 20 years or 50 years from now. That's very important too. That's work done primarily at the National Institutes of Health.

And so what we focus on is things like training, safety, protective equipment, wearing the protective equipment, the goggles, the rapid evacuation -- not just having a great helicopter, but making sure people know how to get to the right person, and making sure they're willing to go in the face of fire, and making sure that they have, to the best we can, the nerves of steel to work under these conditions. These are things that we do pretty well. We always work on doing them better.

And as you know, we've got a lot to show for it. We've got a died-of-wounds rate of 10 percent, versus 23 percent in Vietnam. We've got a disease and non-battle injury rate of 4 percent. That's half what it was in Kosovo. These are major advances.

Having said all that, we have a ways to go. You know, we've worked very hard in this past year to recover from the concerns raised by the media, God bless them, about the care at Walter Reed, the frustrations of the disability system, the delays in getting outpatient treatment, the communications snafus. Under General Schoomaker's leadership, these are being addressed as quickly as government can do it. It's not perfect, but it's getting a lot better. And the surveys show that wounded warriors are increasingly happy with their care. They've recognized, for sure, the efforts that are being putting into it.

Now, having said all that, we still face -- and some members in this room face -- the issue of living with the loss of a limb or some other important part. And while we don't typically, in the military, focus on research for the sake of research -- we try to focus on, you know, practical research, research that will pay off in our lifetime -- when we hit a dead end, where we really need fundamental advances, we can collectively as a military, focus our resources, which are ample, to move that particular rock out of the way.

And one of them is trauma care broadly, and tissue regeneration in particular. And trauma care broadly has not gotten the funding that, say, cancer has and some other areas. So we are trying to make up for that, and in particular in this area of tissue regeneration. And as I think Dr. Schoomaker will tell you, recent advances in stem cell research are so exciting that this seemed like a timely opportunity to bring these resources together. And General Schoomaker, who has the deep academic credentials, who is a physician, a scientist, and who's been in the fight and who is a leader, has done so, and you'll hear the report today, because this is an exciting step forward.

So I'm delighted to say that Health Affairs is one of several funders of this effort, by no means the only one. We expect there to be considerable funding from other government agencies, like the NIH, in particular, will put in defense-wide, not just Health Affairs, but defense-wide about $85 million in funding. And there will be about $180 million from other federal and state agencies, academic institutions and industry. So in that, I'm speaking on behalf of the Office of Naval Research, Air Force Surgeon General, NIH, and on behalf of Dr. Kussman, Veterans Affairs. And I'll ask Dr. Kussman and the others to be available for questions after this because they may have some questions that I can't answer.

So my privilege to introduce a great doctor and leader in American medicine and military medicine, General Schoomaker.

GEN. SCHOOMAKER: Well, thank you, Mr. Secretary. And thank you all for being here today. This is really an exciting day to be in Army medicine and military medicine. It's an exciting day to be in medicine altogether.

I want to welcome General Kussman, Dr. Kussman, and thank you for being here, Mike, a representative of the Veterans Administration, and to our colleagues from academia and our partners in the joint medical force. Today really marks an historic day in Army and military medicine, and it highlights the commitment of all military medical professionals, as Dr. Casscells has discussed, to provide our nation's wounded heroes the very best medical care possible.

In order to accomplish this goal, the Army's Medical Research and Materiel Command, which is a subordinate command of my medical command, is partnering with our Air Force and our Navy colleagues, with the Veterans Administration and the National Institutes of Health. Together we'll continue to build on the early successes in this field called regenerative medicine, unlocking its unlimited potential for future successes, with a primary focus of improving the lives of our injured service members.

The Armed Forces Institute of Regenerative Medicine, AFIRM -- this is the Army, so you're going to get some acronyms -- but AFIRM will be made up of at least two multi-institutional consortia that Dr. Casscells referred to. One's led by Wake Forest University and the University of Pittsburgh, and the other is led by Rutgers University and the Cleveland Clinic.

The United States Army Institute of Surgical Research, represented here today in San Antonio, Texas, part of the Medical Research and Materiel Command, will work with these academic consortia to provide key guidance on military medical needs and to conduct trials of new therapies. These large multi-university institutions are the incubators in the clinical expertise and the basic science expertise that will then develop these regenerative medical products that will be used for our wounded and injured warriors.

The Armed Forced Institute of Regenerative Medicine has a five- year initial cooperative agreement with funding of $85 million, provided by the federal government, along with $80 million in matching funds from universities and local and state governments. An additional $100 million in existing grants from other agencies, such as the National Institutes of Health, in research initiatives bring the total funding to more than $250 million. As far as we know, this is the largest U.S. government-funded research consortium in the field of regenerative medicine.

Not only that, we're bringing together a dream team of some of the greatest minds in tissue engineering and regenerative medicine, some represented here with us today. This is, frankly, a very exciting venture for all of us.

It's also one that's very personal for me. A couple of years ago while I served as the commander of the Army's Medical Research and Materiel Command, headquartered at Fort Detrick and with a subordinate laboratory at the Institute of Surgical Research in San Antonio, we were wrestling with how to treat the many problems caused by this -- the weapons of the current conflict, especially blasts.

Among the mix of wounds we encounter are a large number to the extremities and to face. Eighty-two percent of all our wounded have extremity injuries, 30 percent have wounds to the head and the face, and 6 percent have severe burns. The most seriously wounded often require amputation or extensive reconstructive surgery, which results in long periods of rehabilitation and physical therapy.

It was at this time that we heard a presentation by Dr. Tony Atala from the Wake Forest University, who's with us here today.

He presented a paper to our combat casualty care scientists who were gathered together, conferencing on battlefield medicine and how we could push, how we could advance -- as Dr. Casscell's mentioned -- how we could advance our understanding and our survival and recovery and relocation of our soldiers.

It was during his talk that we really began to understand the tremendous potential for advances and breakthroughs in regenerative medicine. Prior to his talk, I have to say, frankly, that I and many of us thought that tissue engineering and regenerative medicine were decades away from being able to deliver really any meaningful replacement organs or sophisticated structures, regrowing limbs and digits, for example.

Dr. Atala stunned the crowd when he described his experiments to replace damaged bladders using a patient's own cells, grown in a biodegradable bladder implant, a framework or a matrix under which the patient's own cells, not at risk for rejection, could then grow and form a solid multi-layered organ. He showed case results of patients that he had implanted with artificial bladders over seven years previously who had then returned to normal bladder function. He went on to describe similar results in other structures in the body, in which they'd formed tubular structures like vessels and ureters connecting the bladder to the kidney.

At the moment, I was not alone in seeing that this had tremendous potential to solve some of our big reconstructive medical problems facing our surgeons and potential benefit for injured soldiers, sailors, airmen, Marines, Coast Guardsmen. With the help of Colonel Bob Vandre, who is here in the audience, who's really one of the heroes of this saga -- Bob, a career Army dentist, has really taken this project to heart and has been tireless and tenacious in ensuring that this consortium has come together -- we started obtaining the process of obtaining funding from other federal agencies and then setting up a contracting process that has resulted in the formation of the Armed Forces Institute of Regenerative Medicine. It's truly a privilege to see these efforts become reality and then become part of Army medicine and medicine for the entire joint force.

The new institute will work to develop techniques that will help to make our soldiers whole again, will use the soldiers' own stem cells to repair nerve damage, to regrow muscles and tendons, to repair bone wounds and to help them heal without scarring. In addition, the team will work to develop techniques to salvage and reconstruct damaged limbs, hands, fingers as well as facial repair of ears and noses, to help in cranial reconstruction of severe head injuries.

To give you an idea of how this regenerative medicine works, I did bring one slide. I don't know if that's available to us. If it's not I'll just describe it to you. But the slide depicts a young, 22- year old, severely burned Marine, pictured here on the right, who, as you can see, has experienced severe facial burns. And he's undergone at this point in the procedure over 40 operations to repair the damage done by the burn.

But with current techniques, there's really no means of regrowing ears or the tip of his nose.

But using a scaffold in the shape of a nose, as you can see here in the middle of the slide, and seeding it from stem cells, cells which these terrific, innovative scientists have figured out how to turn into any one of a number of cells required to remake a nose, we can direct those stem cells -- we in the corporate sense -- to grow them in large number and then paint them on the outside of this biodegradable scaffold, this scaffold that will resorbed by the body once implanted.

They're incubated by a few weeks until they grow down into the scaffold. The scaffold is then implanted onto the skin of the patient and sewn over. And over the ensuing months, the scaffold will the be dissolved and resorbed into the body. Cells will continue to grow and form a replacement of the structure that was lost.

This procedure has already been done in animals. You can see a picture over here of a mouse that's growing a human ear, to show you on that scaffold that you can form these cells into any of the appendages that we're looking for. This work here was done by -- (names inaudible) -- member of the new Armed Forces Institute of Regenerative Medicine.

So I think you can see, the future of regenerative medicine is truly amazing. We're embarking on a new generation of research that's going to redefine Army and military medicine as we know it today.

We're doing it together with just terrifically enthusiastic and skilled partners, who have been very selfless in coming forward, asking how they can support our wounded and injured soldiers, by making our soldiers, sailors, airmen, Marines, Coast Guardsmen some of the earliest recipients of these really exciting regenerative medicine and bioengineering products.

And we're very grateful for them and we'll welcome them into this family of military research and then care. Most importantly we're doing this really for the care of our wounded warriors. And with that, I'll entertain any questions that you may have.

Yes, sir.

Q (Off mike) -- says that the first clinical trials could begin in about two years. What's been done with this young Marine isn't considered a clinical trial yet.

GEN. SCHOOMAKER: I don't believe that we've reached the point. We've got the representative from the Institute of Surgical Research, that the trial has begun with him.

But some of our earliest work will be growing, for example, new digits for badly burned patients who may lose the capacity to use their hand in a fashion where they can grasp. So some of those are the earliest efforts.

You want to talk about that, Dr. Wenke?

DR. JOSEPH WENKE (Army Institute of Surgical Research): Sure.

GEN. SCHOOMAKER: Let me introduce you to Joseph Wenke. He's a principle investigator at the Army's Institute of Surgical Research down in San Antonio.

DR. WENKE: Yes. Thank you for the question. To date, no, the clinical trials have not started. A lot of these things are going to be done as compassionate care. Currently, there have been a couple different projects for compassionate care, surgeries that have occurred, one for -- as the general talked about -- extending a digit, so somebody who's missing a finger, they're applying a scaffold over time and on a regular basis where this digit is -- hopefully will get you a longer length to allow the person to oppose. And then another person who's missing entire muscle in his thigh, and what's happening is a similar process, but instead of as dust, an actual matrix is being placed in there and hopefully, similar to this ear, will be incorporated by the body cells and regenerated into a functional muscle.

Q These pieces have been implanted on this young man here?

DR. WENKE: No, no. Not to date.

GEN. SCHOOMAKER: Yes, ma'am.

DR. WENKE: Thank you, General.

GEN. SCHOOMAKER: Thank you.

Q Could you just walk us once through -- again once through the nose example? And further, where do the stem cells come from? And then could you in very simple English -- layman's terms -- for those of us who don't cover this kind of thing very often, just walk us through again how it is that you would implant the nose on someone like this young Marine?

GEN. SCHOOMAKER: Well, I'm a pretty simple layman in this respect.

Q Okay.

GEN. SCHOOMAKER: And I'm going to ask Dr. Atala to come up here and just complement what I'm going to say, especially as I get -- the cells that we're talking about actually exist in our bodies today.

Q But where? I mean, how do you --

GEN. SCHOOMAKER: Come up here. Come up.

Q I'm sorry, this is probably very -- (inaudible) -- you, but I don't understand.

GEN. SCHOOMAKER: No, this is a really good question. And most people don't realize this, but 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 a different kinds of cells. We do this on a daily basis, in our own bone marrows, for example. We have stem cells that regenerate our bone marrow or in our liver.

What these gentlemen have figured out how to do is to harvest those and to stimulate them to become any of a number of different cells necessary to regrow organs.

Anthony, did I get it right?

DR. ANTHONY ATALA (Institute for Regenerative Medicine, Wake Forest University): Absolutely, General. Yes, excellent answers, in fact.

So, all your body, basically, all the parts of your body, tissues and organs, have a natural repository of cells that are ready to replicate when an injury occurs. And what -- some of the strategies that are used are to take some of those cells out of the body -- just with a very small piece of tissue, with a very minimally invasive approach where you take just a small sample of tissue from that specific organ. And then you can tease the cells apart, those specific cells that have that potential. Then you grow those outside the body in large quantities. It usually takes about four to six weeks, sometimes up to eight weeks to grow those cells.

Then you go back and then take those cells and use those cells into three-dimensional molds very much like you see there. And you just coat or paint the molds with the cells. Then you take that mold and you place it into an oven-like structure. So you start cooking it, if you will, very much like baking a layer cake. And it's under the same conditions as a human body, 37 degrees centigrade, 5 percent C02, 95 percent oxygen, and it stays there for one or two weeks. And then you have your construct that's fully seeded with the cells.

And then you can implant that back into the patient, into the same patient, thus avoiding rejection.

Q So you would take the cells from this specific Marine here to regenerate his nose or ear, whatever?

DR. ATALA: It depends on the circumstances. Yes, there are several strategies, but certainly this is one. We'll --

GEN. SCHOOMAKER: But we are the source of our own regeneration. With very little risk -- for example -- and correct me if I'm wrong -- for example, conversion into cancer -- that's one of the risks of other forms of stem cells. Adult stem cells don't carry nearly that risk. And so this is an exciting technology.

DR. ATALA: That's exactly right. If I may add, like the general said, the more primitive the cell, the more the potential for that to be -- form a tumor. So the ideal cell currently, for clinical application, is the very cell set in your body.

GEN. SCHOOMAKER: Let me invoke an image for you, because we all began to think about this, especially after people like Dr. Atala began to talk to us about it. We all remember the great pictures of amphibia, like salamanders, who can regrow their tails or regrow a limb. Why can't a mammal do the same thing, and why can't a large mammal? Well, there's lots of good debates about why that is, and there's arcane reasons for that, why we have adopted a kind of approach that says let's stop the bleeding, let's seal off the scar and stop infection and not allow these stem cells to regrow. But in fact, under the right conditions, that's exactly what we're doing. We're converting. And one of the groups has a -- even a motto: Let's convert mammalian physiology into amphibian physiology.

Yes, let me go here, and we'll go back over here now.

Q On some of the things that I've seen associated with this project, there's potential limb regeneration. How far down the road is that? And what do the technologies involve? Obviously a limb is much more complicated than just a simple -- (inaudible).

GEN. SCHOOMAKER: This is where we have the advantage of working with established investigators. These people have been doing this literally for decades now, in a very disciplined fashion, which does -- has not raised unnecessarily expectations from patients or the community before it's a proven thing. It's one thing to grow a single layer of cells in large quantity. It's another to build a multi- layered set of cells. It's another altogether to put that into a hollow organ. It's another to put that into a solid organ or into a multi-layered, multi-organ limb, such as we're talking about.

I can tell you that the preliminary work has already been done to grow small extensions of digits, for example, to provide some function to what would otherwise be an unfunctional kind of paddle after a severe burn to the hand.

Q And to the 900 amputees that you mentioned, I mean, will this provide hope to them eventually down the road or just to a limited number who have had -- (off mike)?

GEN. SCHOOMAKER: I think initially -- and I'm -- correct me if I'm wrong, any of my colleagues here -- but I think, as you heard Dr. Wenke talk about, probably the initial effect will be to provide greater structure to those amputees who may have a partially functional limb but have lost a large amount of muscle mass or who have very damaged skin, that we can regrow skin. I mean, frankly -- and the burn patient is a good example -- the rate-limiting step, the step that threatens life, is trying to close off this large, open gaping wound that is created by the loss of skin and allows entry of foreign, you know, bacteria and the like and threatens life as well as loss of fluids and the like.

So I think that's where we're going to see this use, initially, as Dr. Wenke described, regrowing whole muscle groups in a very badly damaged limb, which may be only partially functional. But if we can get them a new muscle and tendon group, it's going to turn what is only a partially effective limb or stump into a much more functional one.

Would you agree with that, or did I misspeak? (Off-mike response from colleague.) Good.

Yes, sir?

Q I just wanted to be clear. Is this work being done now, on humans, or only on laboratory animals?

GEN. SCHOOMAKER: No, it's being done now on humans. Dr. Atala's been doing this over the last decade, and has implanted bladders and aortas and blood vessels. It's being done on human beings today in very, very well controlled careful clinical trials with studies for outcome, meaning we're not just going to do the surgery and see if we can -- if that organ implanted survives for a week or a month, but we want to see years out that we now have a fully functional organ again. And that's been one of the real blessings of working with this group.

Did that answer your question?

Q Yeah.

GEN. SCHOOMAKER: Over here?

Q Can you explain in just a little more detail what it is about the nature of this particular conflict, these particular conflicts in Iraq and Afghanistan that have led to these sorts of injuries and a need for this kind of -- (inaudible) -- research.

GEN. SCHOOMAKER: That's a great question. That's a great question.

A couple things. You'll often here people talk about the signature wound of this war being this injury or that injury. I can tell you, from my perspective, the signature weapon of this conflict is blast, and blast is a potentially devastating weapon which can burn, can result in amputation of limbs, that can result in loss of eyesight and hearing, that can damage brains and obviously, as we're all concerned, can lead, because of the context of the conflict for the combatant, to many post-traumatic stress results.

But coupled with the technologies that we use on the battlefield, beginning with the nature of the protective equipment that we place on our soldiers and Marines and others and our vehicles, we have provided the combatant now with much greater protection against life- threatening wounds.

We've armed them with a fellow combatant, an infantryman or Marine who knows, a buddy who knows, at the moment of injury, how to begin lifesaving steps before that medic gives. We've provided them with a better trained medic, more technically proficient, with better equipment. We have looked at every step of the evacuation and treatment to improve outcome.

And now what we have are devastating blast-induced wounds, which in a prior conflict would have resulted in almost, you know, death in the first few hours to days afterwards, to survival.

So we're seeing survival of soldiers, sailors, airmen, Marines, Coast Guardsmen that we would never have seen in a prior conflict, even from levels of injury, what we call the Injury Severity Score, that exceed anything seen in the private sector, seen in our trauma centers in the United States. We know that, because our trauma surgeons go over to Landstuhl, Germany, or go into Baghdad, and work along with our surgeons and report that back to us.

So we've got a system of medical care. It's a good news story. We've got a system of care, of coupling with the developers of materiel to protect our soldiers that have pushed survival from battlefield wounds higher than it's ever been before. But as a consequence of that, we brought back now a group of soldiers that had survived their wounds but now have challenges in rehabilitation and recovery.

Yes, sir.

Q Do you all envision, I mean, someday down the road, growing these sorts of things in advance, when they're needed on the field right away?

GEN. SCHOOMAKER: That's a great question.

I mean, we've talked about a repository of one-zone stem cells, or stem cells that are identical to those that we all carry, that upon notification of a soldier being badly burned, we can begin growing replacement skin almost instantaneously.

So by the time they arrive a couple days later, at the burn center or the Institute of Surgical Research, we've already started to harvest the skin that's going to be required to cover it. You have anticipated exactly our thoughts.

Yes, sir.

Q (Inaudible) -- compartment syndrome. Could you explain that a little bit, how these new technologies help that?

GEN. SCHOOMAKER: Compartment syndrome is kind of the technical term that was used to describe what Dr. Wenke and I just talked about, with replacing muscles.

In a very severely damaged limb, like the lower leg or the forearm, there are compartments of very rigid tissue that contain vessels, nerves -- blood vessels -- excuse me, in muscles, that, because of the damage and the swelling that ensues following the injuries, shuts down circulation and effectively destroys the muscle inside. That's called a compartment syndrome.

We respond surgically if it's timely, and to try to decompress that compartment, but it often results in a devastating loss of muscle, nerve vessels inside. And this technology is intended to replace those damaged muscles and vessels.

Does that answer your question?

Q Yes.

GEN. SCHOOMAKER: Yes, ma'am.

Q So in Pentagon terms, $250 million doesn't sound like a lot of money. What can you meaningfully expect to develop over -- you know, see the foreseeable future that could benefit vets today?

GEN. SCHOOMAKER: Wow. $250 million, I --

Q At the Pentagon, sir, you know well that that's not a lot of money.

GEN. SCHOOMAKER: But for medics, that's a great starter seed- corn for demonstrating the utility of what we're talking about, and stimulating an exciting -- the community at large -- I just see this as the beginning of a process that's going to attract more and more interest and more and more support. I mean, we're doing what we can as a military and what we can as a federal system to do that. And I'm encouraged to hear you say that this is just the beginning of this, and that we shouldn't think of 250 million (dollars) as the final size that we could see invested in this.

Q Well, do you foresee this -- wasn't it 80 million (dollars) coming out of DOD?

GEN. SCHOOMAKER: Yes, ma'am.

Q You foresee that being an annual appropriation or sort of one-off?

GEN. SCHOOMAKER: No, I think we've projected this over a five- year timeline, so we're doing what we can to help our academic and industry partners provide a part of the total investment portfolio that they require to do this. And we're responding to their requests and their demands.

Bob, do you want to comment about that? Come on up here.

COL. ROBERT VANDRE (Army Medical Research and Materiel Command): There's a part of the equation that you might not know about. The National Institutes of Health actually funds about $500 million of stem cell research every year, yearly. But they don't have a program where it puts it all together to actually put it into -- to translate that into patients.

And this, actually, will take a lot of this research -- and most of the researchers -- I think in your handout -- did you give them a copy of all the researchers? Did that get in there? Yeah, there's a copy of all the principal investigators in there. Most of them have -- already have funding from the NIH that makes up some of the -- supports funding for this.

But what this will do is take all that research that's being done and take the best of it that can be -- help us and put it all into something and actually get then translated into a patient. So there is a lot of other funding -- federal funding going into this, which isn't, you know, part of what we're actually doing, but it'll help.

GEN. SCHOOMAKER: And Bob brings up a -- Dr. Vandre brings up a very important part, that one of the things that we in the joint medical research community pride ourselves in is working with academic and federal partners to find the very best candidates for these kinds of things, things that are coming out of basic science. I mean, we're building -- we're standing on the shoulders of generations of basic scientists who have laid the foundation through bench research to do this. We are plucking some of the very best ideas and some of the very best products that can be found and moving that as quickly as possible to the bedside and into the operating rooms for our patients. And that's really --

STAFF: Time for about one more.

GEN. SCHOOMAKER: Pardon me?

STAFF: We've got time for about one more, maybe two.

GEN. SCHOOMAKER: Okay, let me get you in. We'll go back to you.

Q Sir, you mentioned that Dr. Atala has been doing clinical research for the past 10 years, yet here -- (inaudible) -- talks about starting clinical trials within two years. Is there --

GEN. SCHOOMAKER: (Off mike) -- this class of injury and this kind of a(n) appendage.

Q (Off mike) -- some of the research that Dr. Atala is doing begin to be applied immediately to the war wounded?

GEN. SCHOOMAKER: I think as needed, yes, sir. I mean, Dr. Atala is a pediatric urologist by training, and he's been doing this work in that community of urology for some time and has been -- and has been doing work for living patients for some time.

Q So there'll be a number of clinical trials with regard to various aspects of this?

GEN. SCHOOMAKER: Oh, yes, sir.

Yes, sir?

Q What's the role of industry? How do they -- how does industry play into this?

GEN. SCHOOMAKER: Well, historically, what industry has represented to us -- industry frequently does not want to take the research and development risk to develop the basic science necessary to bring these products to fruition. But once they see the potential and the opportunity, they become very, very active in the process and join with us. And we are always looking for industry partners to help us with the materials necessary to make these things useful and enduring. So industry, if not already engaged, will, I'm certain, be increasingly a part of this equation and has always been.

Q What about patents and that kind of thing?

GEN. SCHOOMAKER: That's a part of the agreement that put together this consortium. All of the legal framework for intellectual rights and patents and the like has got to be written into the framework of this cooperative research agreement.

(Cross talk.)

Okay.

Q Since we have the opportunity to speak with you today, I was wondering if you could just give us your reaction to this RAND study that's out today. You've spoken a lot to us in the past about PTSD and TBI. (Off mike) -- troops coming back from Iraq and Afghanistan, experience symptoms of PTSD, TBI.

Have you seen the study?

(Cross talk.)

GEN. SCHOOMAKER: I have. I actually received an outbrief from the team.

I thought the team was an extremely talented, very professional group that, I think, used some great survey techniques to essentially validate, in my view, much of the work that we've been conducting, within the military community for the past five years.

It was encouraging to see that what they are seeing, by sampling soldiers of all components nationally, really echoes many of the themes that we have seen, in terms of the emergence of symptoms of post-traumatic stress. And it encourages me that if we again are aggressive about screening, early in the reintegration of a returning warrior, that we can find these symptoms, that we can begin applying the necessary evidence-based treatments that we know work.

And we've got -- the RAND group is equally passionate about our applying those practices and those treatments that have been shown effective in these conditions, and that we will see recovery and prevent long-term disability from post-traumatic stress disorder.

I think they're raising, helping us to raise, the visibility and the attention that's needed by the American public at large, with leadership from groups like the Veterans Administration that have been working in this area for decades to focus the efforts of everything from primary care providers, family practitioners and internists and nurse practitioners right up into specialists in behavioral health, to focus our energies on early screening and treatment of these folks.

Q Did any of the barriers that they mentioned specifically concern you? The security clearance concern was one that we hadn't heard much about before today.

GEN. SCHOOMAKER: Well, I think barriers, if I recall, was used in a very generic sense to mean anything that would impede access of a returning soldier or family to care.

And that might be a geographic barrier that puts them at some distance from where they need to get care. It involves, in some cases, a stigma or economic barriers. And I think they're helping us to identify what those barriers are so that we can systematically go after them.

We know from the last five years of studies and our application of what we call "Battlemind Training," to build resilience and then to educate families and soldiers upon return about what are the symptoms of post-traumatic stress, that that coupled with the chain teaching that our chief of staff and secretary of the Army conducted last year across the entire force has begun to lower the stigma associated with seeking care, such that we're seeing in subsequent Mental Health Advisory Team studies more and more willingness of our soldiers to seek care.

And so the RAND study, I think, is helping us identify what those barriers are and give us strategies for how we can go after it. The other thing that I'm very encouraged by is they're making this a national debate.

Does that answer the question?

Q Yes.

GEN. SCHOOMAKER: Okay. Well, thank you very much for being here.

STAFF: Just a special thanks to people that traveled to the Pentagon today to be with us. And I've been asked to make one administrative note that has to do with the Marine's picture here. The image -- in case you were wondering, he gave specific consent for use of this image today in this presentation.

So, thank you.

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