Mixing biological and synthetic material isn't a new idea, but there are currently no similar products used for facial reconstruction or enhancement, according to doctors in the field. Elisseeff mixed different concentrations of each and injected them into the backs of rats until she found the one with the greatest long-term stability — more than a year with no deterioration during tests.
Once she found a formulation that worked, Elisseeff enlisted a small number of patients who were already undergoing tummy tucks to try out the new material. They had five drops of the material or hyaluronic acid alone implanted for 12 weeks before their procedure. The hyaluronic acid dissipated as expected, but the new material kept its size and shape.
She's already tweaked the material to address some inflammation that developed in the patients. And she's now working with an independent ethics committee to set up parameters for wider human trials and reaching out to doctors at Hopkins and in private practice to recruit patients.
Almost $2 million in funding going forward will come from the Department of Defense, which is interested in the applications for soldiers with blast injuries and others.
The original funding and inspiration came from a small Los Angeles cosmetic drug company, Kythera Biopharmaceuticals. Its co-founder and then-chief science officer said he'd been watching "Star Trek."
Nathaniel David said in this episode of the '60s sci-fi series Captain Kirk needed pointy ears and an upswept brow to disguise himself as a Romulan. That required only a quick trip to sick bay. David wondered how hard it would be to give real-life patients such easy access to desirable facial features, including noses, chins and cheeks.
He offered Elisseeff several million dollars to investigate the new frontier. And he now believes her discovery could be available in a couple of years, after extensive human trials expected to being as early as January.
"This technology would be more like painting than carpentry," he said. "You could have Brad Pitt's chin done in five minutes with no down time."
While no such technology is now available, there have been other advances in laboratories around the country. Much work is being done with patient cells, harvested from the nose or blood, to create custom bone, cartilage and skin for patients.
Elisseeff has also worked on other biomedical advances in tissues, adhesives and corneas.
Another company that has been working on biomedical advances is KCI, a medical technology company based in San Antonio, Texas. Dr. Ron Silverman, the chief medical officer, said research there already has led to changes in the way surgeons perform cosmetic and reconstructive procedures. Among KCI's products is AlloDerm, which is derived from human skin and is now commonly used in breast reconstruction after a mastectomy.
It comes in a sheet a couple of millimeters thick and is used to reconstruct the lower half of the breast, serving as a base and reinforcing the silicone implant that forms the top half of the breast while allowing for a more natural appearance. It also allows women to have their reconstruction in one surgery instead of two, shortening the ordeal and saving time and money, Silverman said.
The material is also used on burn victims.
Silverman, who is also a plastic and reconstructive surgeon at the University of Maryland and an adjunct associate professor at Hopkins, said other areas of regenerative medicine are promising for patients not well served by what's available now. He said he'll be watching progress made by Elisseeff, with whom he has collaborated in the past.
"We're watching what's going on," he said. "Something injectable like [Elisseeff's] material might provide an answer."