Clinical Trials Seek to Improve Warriors’ Burn Care

FORT DETRICK, Md. — 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.”

U.S. Depart­ment of Defense
Office of the Assis­tant Sec­re­tary of Defense (Pub­lic Affairs)

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