Expectations for Regenerative Medicine on the Rise

 
Army Col. Robert Vandre, MD
Robert Vandre

According to the Brookings Institute’s Iraq and Afghanistan indexes, from March 2003 through February of this year, more than 36,000 U.S. troops have been injured serving their country in Operation Iraqi Freedom and Operation Enduring Freedom. According to the Army of the Surgeon General’s Office, from September 2001 to January 2009 there were 1,286 amputations performed due to the conflicts in Iraq and Afghanistan. Doctors on the battlefield are saving more lives than ever before.

Service members survived the war but the question now becomes how are they going to survive the next 50 to 60 years with serious traumatic injuries? Army Col. Robert Vandre, MD, program director for the Armed Forces Institute of Regenerative Medicine (AFIRM), is looking to regenerative medicine for the answers.

Modern Medicine

High expectations surround the new field of regenerative medicine. On its Web site, the McGowan Institute for Regenerative Medicine describes a treatment that will one day free a child from insulin injections, allow damaged organs to regrow and heal wounds without scars. Regenerative medicine has the task of solving modern medicine’s most challenging diseases. But what is it?

Regenerative medicine consists of specialized tissues and cells, such as stem cells and scaffolds. Adult stem cells – unspecialized cells capable of renewing themselves through cell division – secrete growth factors that promote growth and have the capability and potential to treat and improve wound healing.

Scaffolds are biodegradable biomaterials, which form the shape of what will be grown, Vandre said. Regenerative medicine has the potential to form new bone, skin, nerves, tendons, muscles and replace damaged tissues and nerves.

“If you take a scaffold and shape it like a finger bone and plant bone cells from an individual and bone growth factors, you will end up with a bone the exact same shape as a finger bone,” Vandre told O&P Business News.

The most common bone growth factor is a genetically produced protein called recombinant bone morphogenic protein (rhBMP-2). This protein has the capability to stimulate a patient’s own cells to make more bone. This protein can benefit patients with bone fractures and bone disorders. Vandre explained that his research team has been successful at regrowing finger bones for wounded service members. This could be a precursor to Vandre’s long-term goal of regrowing entire limbs. Although that goal is admittedly lofty.

The health care industry has been aware of the potential of regenerative medicine, however, until recently, scientists struggled to grow cells outside of the body.

“We now understand DNA,” Vandre explained. “There has been an explosion of knowledge in the last 20 years that really allowed regenerative medicine to blossom.”

AFIRM

 
Extracellular matrix has been used to regrow muscle in two patients
Extracellular matrix has been used to regrow muscle in two patients.
Image: AFIRM

“We realized that regenerative medicine has the potential to get the body to regrow damaged structures that we can not repair surgically,” Vandre said. “That is why AFIRM was created.”

According to its Web site, AFIRM is a multi-institutional, inter-disciplinary network working to develop advanced treatment options for servicemen and women. AFIRM transfers the basic research of reputable institutions into clinical trials.

AFIRM has five major research programs – limb repair and salvage, craniofacial reconstruction, burn repair, scarless wound repair and compartment syndrome repair. By transitioning basic research to clinical trials, AFIRM hopes to accelerate the delivery of regenerative medicine therapies to the most critically injured service members.

“When we first started AFIRM, we knew we were having trouble finding clinical solutions to these five traumas,” Vandre explained. “We thought if we could come up with a clinical solution to just one of them and get it to clinical trial within 5 years, then we would be successful.”

Vandre said that regenerative medicine requires a multidisciplinary team.

“You can not have just one person that understands tissue culture, you also need to have researchers who understand biochemistry, immunology, tissue engineering and surgery,” Vandre explained. “You have to assemble a team. And we’re talking about a team that spans more than 10 different disciplines that also requires large labs in several locations. This requires money.”

The institute is funded through the U.S. Army Medical Research and Materiel Command, along with additional funding from the U.S. Navy, U.S. Air Force, the National Institute of Health and the Department of Veterans Affairs. Last year, Congress added $273 million for medical research to a supplemental bill that pays for the wars in Iraq and Afghanistan. AFIRM secured $10 million of those dollars for funding of three additional clinical trials.

Clinical trials

AFIRM has yet to come up with solutions to any of the five traumas, but the clinical trials being produced are promising first steps.

As of late February, three clinical trials were underway with five more beginning within the next year. This has caught the attention of wounded soldiers around the world who have survived horrific improvised explosive device and war conflict injuries.

In one trial, researchers applied regenerative medicine to a soldier who lost most of his thigh muscle to a roadside bomb. Researchers applied an extracellular matrix from a pig’s bladder to the wound. The procedure has already been performed on two patients.

“If you can regrow muscle, you can sometimes save a limb. We have a clinical trial on regrowing thigh muscle. We have actually regrown 10% of a thigh muscle on a wounded warrior,” Vandre said.

According to Vandre, researchers have created scaffolding containing cells and growth factors to the shape of noses and other missing body parts in order to grow new tissue. Vandre estimates that clinical trials on noses and ears are at least 2 years away.

“These clinical trials have the potential to make a big difference for our wounded warriors,” Vandre said. “I get truly excited about once a month. I am continually amazed.” — by Anthony Calabro

Perspective

The more than 30 research institutions that make up the Armed Forces Institute of Regenerative Medicine (AFIRM) are working as a team to apply advances in regenerative medicine to battlefield injuries. The scientists of AFIRM see the initiative as a tremendous opportunity to make a difference in the lives of men and women who have given so much to our country. The goals of AFIRM are many, but the potential for meeting them has never been higher.

Advances in medical care have increased the number of warriors that survive battlefield injuries, but are often left with life-altering disabilities. Regenerative medicine offers the hope of developing new therapies to prevent and treat these disabilities — from preventing scarring to harnessing the body’s natural healing powers to regenerate tissue.

In the last two decades, scientists have attempted to grow native and stem cells, engineer tissues and design treatment modalities using regenerative medicine techniques for virtually every tissue of the human body. Advances in the field, such as learning to expand cells outside the body, have resulted in new treatments that are already benefiting patients. Various tissues are at different stages of development, with some already being used clinically, a few in preclinical trials, and some in the discovery stage. Due to advances in cell science, a variety of cell types are available for these efforts. The future will see an expansion in the use of regenerative medicine technologies — for both more medical indications and more patients.

— Anthony Atala, MD
Director, Wake Forest Institute for Regenerative Medicine

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