Regenerative Medicine Clinical Translation

Regenerative Medicine Clinical Translation

The Pittsburgh Tribune-Review recently highlighted two ongoing clinical trials featuring the technologies of McGowan Institute for Regenerative Medicine affiliated faculty members. As reported by author Luis Fabregas, “Scientists [all over the world] are working to build organs to replace those that have been damaged beyond repair. In recent years, tissue-engineered skin has been used to close gaping wounds, temporarily cover burns, and even treat foot ulcers in diabetics.” In Pittsburgh, projects at the McGowan Institute involve the use of a material called the extracellular matrix (ECM) to repair deformities in muscles and soft tissues caused by injury, disease, or wounds. Another research project uses fat-derived stem cells to repair facial defects after trauma and after a craniotomy, a cut that opens the skull to access the brain.

“We’re peeling back the complexities,” said William Wagner, PhD, director of the McGowan Institute for Regenerative Medicine, and a professor of surgery, chemical engineering, and bioengineering at the University of Pittsburgh. “We know a lot more than we did before about how cells behave. In very well-controlled systems, we can get these cells to do things that previously we weren’t able to do.”

Current treatment options for the loss of large masses of muscle tissue are limited. A regenerative medicine approach that could reconstitute functional muscle-tendon tissue, as well as associated nerves and blood vessels, would represent a paradigm shift in the treatment of traumatic tissue injury. The proposed approach of a study led by McGowan Institute deputy director Stephen Badylak, DVM, PhD, MD, professor in the Department of Surgery, and director of the Center for Pre-Clinical Tissue Engineering within the Institute, involves the use of an “off the shelf” biologic scaffold material that would replace the missing soft tissue, initiate a stem/progenitor cell recruitment process, and facilitate site appropriate functional tissue restoration.

The major focus of the Badylak Laboratory is the development of regenerative medicine strategies for tissue and organ replacement. The use of mammalian ECM or its derivatives as an inductive template for constructive remodeling of tissue is a common theme of most research activities. The goal of all projects is clinical translation and improved patient care.

In clinical trauma research, the U.S. Army’s Institute of Surgical Research (ISR) is examining a variety of combat casualty care problems in trauma patients. ISR is recognized worldwide for its contributions to improved trauma survival. In partnership with the ISR, Dr. Badylak’s ECM technology is used today to help heal soldier lost muscle tissue wounds.

Learn more about this trial involving muscle loss due to severe trauma here.

McGowan Institute for Regenerative Medicine faculty member J. Peter Rubin, MD, chair, Department of Plastic Surgery, director of the Center for Innovation in Restorative Medicine, UPMC Endowed Professor of Plastic Surgery, and professor of bioengineering, University of Pittsburgh, received a major funding award from the Department of Defense (DOD) to help wounded soldiers recover from devastating facial injuries using innovative surgical technologies based on the biology of fat tissue.

The research program involves the treatment of 20 injured soldiers with facial injuries. “As many as 26% of wounded soldiers suffer facial injuries, and these can have a great impact on quality of life. While we can reconstruct the bony structure fairly well, it is the surrounding soft tissues that give people the recognizable human form. This project investigates how soft tissue grafting can more precisely restore facial form and improve the lives of our wounded soldiers,” Dr. Rubin says.

The 1.6 million dollar funding award, known as The Biomedical Translational Initiative, is a program under the Office of the Assistant Secretary of Defense for Health Affairs. The program objective of The Biomedical Translational Initiative is to fund the demonstration and validation of innovative technologies to improve the clinical outcome of wounded military personnel.

“Fat grafting, or moving fat tissue from one part of the body to another, has been used as a cosmetic procedure for decades,” comments Dr. Rubin, “but we are now applying this technology for reconstructive surgery to accurately restore facial form after battlefield injuries.” The use of fat grafting for serious facial injuries, such as those resulting from roadside bombs, is facilitated in this project by specially designed devices and instruments for harvesting the fat tissue and implanting it into regions of scarred tissue.

Learn more about this project here.

The success of these projects, Dr. Wagner said, depends on applying knowledge gained from proven procedures that use stem cells, such as bone marrow transplants.

“The key is getting that fundamental knowledge and translating it into practical knowledge,” Dr. Wagner said. “It’s taking the fundamentals that we have learned around the world about how cells behave, how they differentiate, how they die, and figuring out how they generally control that process in the body of diseased patient.”