Stemnion, a privately held company taking an innovative approach to treating wounds through regenerative medicine, has finished enrollment for first-phase clinical trials and is expanding its South Oakland operations.

Co-founder and CEO George L. Sing said the company, started in 2004 with a staff of five and 1,000 square feet of space, with the help of some government seed money now employs more than 30 and takes up 20,000 square feet at a facility on Technology Drive, near the Hot Metal Bridge.

With the expanded space for further research and development, manufacturing and clinical trials and plans for additional hiring, "we've done a lot, but there's much more ahead of us," he said at a news briefing Tuesday.

The field of regenerative medicine, he predicted, is "probably going to be the next big industry that the whole world will be competing in."

The specifics of Stemnion's work are proprietary. Retired University of Pittsburgh Medical Center surgeon David Steed, Stemnion's vice president for clinical development, said the process involves "tricking" a cell to produce material that will help the healing process. But he declined to give specifics about how cells are harvested or how the process helps wounds mend.

What he is eager to discuss is the potential for healing difficult wounds if Stemnion's approach works.

As a 30-year vascular surgeon, Dr. Steed saw firsthand the suffering of people with diabetes with wounds that wouldn't heal and burn victims with potentially life threatening injuries.

About 20 million Americans have been diagnosed with diabetes, he said, and there are 60,000 to 80,000 diabetes-related amputations of feet or fingers yearly because of wounds that won't heal.

"If you can impact 10 percent of diabetic amputations, that would be a game changer," he said. "That would be 800 thank-you notes coming to us every year."

Though involving a smaller number of cases, Stemnion officials also make special note of the possibilities for effectively treating war wounds. "There's a certain satisfaction that we're going to do something to help young people," said Dr. Steed. "These are people who are putting their lives on the line every day."

For the first phase of the clinical trial, Stemnion has enrolled 17 patients at three undisclosed centers, none in Pittsburgh, who will be the first to receive the treatments.

In this initial phase, Food and Drug Administration investigators want to make sure the treatment is safe, which Dr. Steed said should be determined in about two months.

Then Stemnion will move on to further trials, expanding the number of patients and possibly varying dosages, as it tries to determine if the treatment works.

Manipulating one cell in a laboratory is quite different from doing so on a large scale, Dr. Steed said.

Those tests need to be done before the treatment is widely available, probably not before 2013.

Stemnion's work "is going to change the way we think about the healing process," said Allegheny County Executive Dan Onorato, one of several politicians on hand Tuesday to mark the occasion. "When you actually see what they do, it's amazing."

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