Stemnion looks to cell-growth future
Stemnion Inc., a Pittsburgh company at the forefront of what's known as regenerative medicine, has begun the long process of gaining Food and Drug Administration approval for its human cell-growth technology.
"There currently is no such thing as off-the-shelf skin, but with success in regenerative medicine, there could be off-the-shelf skin," said David L. Steed, for 30 years a practicing vascular surgeon at the University of Pittsburgh Medical Center, who joined Stemnion in July as vice president, clinical development.
Steed spoke Tuesday as Stemnion celebrated its success with the debut of 20,000 square feet of research and development laboratories, a cell processing facility and offices, housed on the first and second floors at 100 Technology Drive in the Pittsburgh Technology Center. The 5-year-old company relocated from just 2,000 square feet of space on the South Oakland building's fourth floor.
"It was a federal, state, local governments and private industry partnership that made this possible," CEO George L. Sing said.
The cost of renovating and constructing the space was about $2 million, with funding provided by Allegheny County and the state. Construction included two "clean rooms," facilities with controlled environments to reduce possible contamination.
Steed said the first of three phases that make up FDA clinical trials, testing which determines if a process is safe for humans, has about two months remaining. The trial involved 17 burn patients, none from Pittsburgh, being treated in three burn centers, none in the area, he said.
"We're growing human cells from donations made by volunteers," Steed said. "For the safety trials, we tweaked human cells to make products that we then placed on the patients' burns."
If all three trial phases go well, Steed said it's possible Stemnion's cell-based products could be ready for commercialization in 2013.
While the possibility of growing human tissue for burn patient and war wound treatments gets a great deal of attention, Steed said the treatment of diabetes, which he said impacts more than 20 million Americans, could be helped through Stemnion's efforts. He said 80,000 amputations occur annually as a result of complications from diabetes.
"Diabetics get a wound the size of your thumbnail that doesn't heal, and a week later they have to have their leg amputated," Steed said. "If we can change just 10 percent of those amputation outcomes using regenerative tissue to heal wounds, that's exciting."