Clinical Trials Seek to Improve Warriors’ Burn Care

By Donna Miles

American Forces Press Service

FORT DETRICK, Md., March 18, 2011 – New hope is on the horizon for wounded warriors suffering debilitating burns as the Armed Forces Institute of Regenerative Medicine and its partners at leading medical research centers launch three promising clinical trials.

Burns are among the most painful and debilitating battlefield wounds and often turn deadly if infection sets in. In an effort to speed up the development of revolutionary new treatments for burns and other common battlefield injuries, the Defense Department launched AFIRM in 2008.

Just three years into the program, AFIRM is seeing big signs of success as it helps advance technologies that use laboratory-grown tissues and biosynthetically developed compounds to treat injuries and illnesses. The ultimate aim of regenerative medicine is to enable patients’ bodies to re-grow bones, skin and tissues -- even whole organs and limbs.

Ten clinical trials already are under way or about to start in five areas specific to wounded warrior care. Three focus on burn repair.

The idea, explained AFIRM Director Terry Irgens, is to push the envelope in exploring technologies that, while promising, are simply too expensive for the private sector to pursue alone.

With funding from the Army Medical Research and Material Command, as well as the Navy, Air Force, National Institutes of Health, Department of Veterans Affairs and other public and private entities, AFIRM is helping advance technologies over the gap referred to as the “valley of death.”

“It’s where the existing technology ends, and there is a gap and nobody has the funding to get it to the next step,” Irgens said.

Two research consortia, made up of some of the best and brightest minds from 31 universities, are partnering with the U.S. Army Institute for Surgical Research at Fort Sam Houston, Texas, to help bridge that gap.

The goal is to get an industry partner to step in and pick up where they leave off, Irgens said. “Once you get some good, promising data, that’s when the commercial companies will come forward,” he said.

One of the new clinical trials, now entering its second phase, involves spraying a patient’s own healthy cells onto the burned area.

Seven patients already are enrolled in the trial, with a quota of 106 to participate based on the Federal Drug Administration protocol, Irgens said. As many as a dozen hospitals will be involved in the trial, with the Army Institute for Surgical Research expected to join it this summer.

Dr. Smita Bhonsale, AFIRM’s deputy director for science and technology, explained how the spray treatment works. The patient is rolled into the operating room, where doctors harvest a postage-stamp-size piece of skin from an unburned part of the body. The biopsy is broken apart into single cells, which are then suspended in a gel-like solution so they can multiply and create new skin tissue. Within a matter of hours, the cells are sprayed onto the patient’s burns, covering an area up to 80 times the size of the original biopsy.

The procedure requires no skin grafts and, because the cells are grown from the patients’ own tissue, there’s no risk of rejection.

Another clinical trial, also entering its second phase, will use the patient’s own healthy skin cells and multiply them in a flask under laboratory conditions. But rather than spraying the new cells onto the patient, doctors will apply the new cells as sheets of skin.

Up to 14 patients are expected to participate in that clinical trial, to be conducted at the

Army Institute for Surgical Research.

Unlike the spray technology that’s effective only on more superficial burns, this process can be used to treat patients with more severe, third-degree burns, Bhonsale explained. It eliminates the need for extensive and repeated skin grafting, and because it uses the patient’s own skin cells, the body won’t reject the new cells.

While promising, the technology isn’t without its drawbacks. The new skin takes up to six weeks to grow -- requiring other temporary dressing to prevent infection and protein loss.

A third clinical trial, now entering its second phase, will use a biosynthetic skin substitute to treat deep, third-degree burns. Thirty patients are expected to participate at four proposed sites, including the Army Institute for Surgical Research.

The advantage of biosynthetic skin is that it can be developed in a laboratory setting and put into storage in a refrigerator until it’s needed, explained Army Lt. Col. Brian Moore, AFIRM’s deputy director.

“This is something we are very interested in because we can grow a lot of it and then put it on the shelf,” he said. “Then when someone gets burned, we can take that off the shelf and apply it.”

Because burn patients could receive this treatment immediately, they have less risk of infection and protein loss. And, unlike skin from cadavers, which typically is used as a temporary wound covering for burn patients, the biosynthetic skin contains substances that help the body better accept future skin grafts, Moore explained.

But there’s a down side to this treatment, too. Biosynthetic skin is a temporary fix, and at least for now, and must be removed later and replaced with living cells. Also, the new cells have no pigmentation or sweat glands, but Bhonsale said scientists already are at work on the next-generation technology to address the shortcoming.

Although all of the clinical trials are being conducted independently, Irgens said the synthetic skin, if it achieves FDA approval, could someday allow burn patients to begin healing until their own harvested cells are able to take over.

As the clinical trials go on, AFIRM is exploring a broad range of other products and technologies to better treat burn patients. One is a specially designed “skin gun” that sprays a solution of cells and water onto burn areas without injuring the cells.

Another new device, called the BioPrinter, looks like a typical ink-jet computer printer. But instead of different-colored inks, its cartridges are filled with skin cells grown from the patient’s own healthy cells. The printer sprays them onto the wound to promote a healthy recovery.

AFIRM also is working to develop better bandages to promote burn healing and burn treatments using molecular iodine, the spice curcumin found in Indian curries, and stem cells from amniotic fluid, placenta, bone marrow and fat.

Irgens emphasized that technologies being advanced by AFIRM all have to go through a long FDA approval process and won’t be delivered to the marketplace for at least three to five years. “FDA is very particular, and we want to make sure everything is safe,” he said. “That’s the first concern we all have. We do not want to harm any patients. We want to make them better.”

But once the approvals come and the technologies advance to the mainstream, Irgens said he believes the work started under the AFIRM program will have a far-reaching impact. “We feel this is very critical therapy. This is going to change the landscape, once this gets approved,” he said. “It undoubtedly is going to move the level of care up a notch.”

That will have a huge impact on wounded warriors suffering from burns, Moore said. “The big thrust behind this is trying to restore people back to normalcy,” he said. “You will never completely restore that functionality they had prior to the injury. But at least you will allow them to have some kind of normalcy and functioning in their day-to-day activities.”

The benefit will extend far beyond the military, Irgens said. “We are not developing anything military-unique,” he said. “We are developing technology that could support mankind -- both civilian and military.”