From staff reports

Sanford Health is launching its second adipose-derived stem cell clinical trial – this one focusing on leg wounds that aren’t healing.

The trial, which opened in September with expanded criteria, is a phase 1 trial to study the safety and efficacy of using adipose-derived stem cell therapy as a treatment for nonhealing leg ulcers.

It’s open to participants 18 and older who have a wound 3 to 25 centimeters squared – or about 1 to 9 inches — and have an A1C of less than nine. A nonhealing leg ulcer is an open sore that has been present for at least three months.

“We have a mission here at Sanford to use research and clinical trials to make a real difference in people’s lives,” said David Pearce, executive vice president of innovation and research at Sanford Health. “This clinical trial can help explore treatments for people with nonhealing wounds, including people who have diabetes and others with conditions that affect their quality of life.”

Sanford pioneered using fat-derived adult stem cells earlier this year in a clinical trial to treat rotator cuff injuries. It was the first FDA-approved clinical trial using the approach on shoulder injuries.

“The researchers of Sanford Health are dedicated to safely testing how adipose-device stem cells can heal the body,” Pearce said. “We aim to truly legitimize the use of adult-derived stem cells for healing purposes in the United States.”

The newest trial will accept 36 participants. Dr. Bradley Coots, a plastic surgeon at Sanford, is the trial’s principal investigator. Clinical investigators in this study include vascular specialists from Sanford Wound Clinic. This team will conduct follow-up visits with participants after they receive the initial treatment. For information or to discuss qualifications, call 605-328-1368.