Sanford Health Hospitals Initiate Stem Cell Research

Sanford Health hospitals located, at Fargo, North Dakota, and Sioux Falls, South Dakota, have launched two Food and Drug Admiration approved clinical trials using stem cells extracted from abdominal fat.

The cells are being used to treat two separate problems—small and partial thickness tears in the rotator cuff and hard-to-heal skin ulcers said David Pearce, M.D. president of Sanford Research in Sioux Falls.

Eighteen participants are enrolled in the orthopedic trials at Sanford’s Fargo and Sioux Falls locations. Pearce reported that, after six months of the trial treating the rotator cuff injuries, there have been no adverse effects. The hospital system is now aiming to expand the trial to 100 patients in the spring.

The goal of a second trial will be to assess the ability of the cells to heal recalcitrant skin wounds more rapidly. “It’s very hard to heal ulcers,” Pearce said of the second trial with a goal to heal the wounds more rapidly. The ulcer trial is only being conducted in Sioux Falls for now but, but Pearce said it may eventually be offered in Fargo, as well.

According to Pearce, these studies put Sanford on the leading edge in applying fat-based stem cell therapy to orthopedic treatments.

The hospital system chose to investigate the rotator cuff injuries because it is one of the most common joint injuries and is easy to monitor, keeping the initial trial as simple as possible.

In an hour-long procedure, doctors suck fat from the abdomen. The stem cells in the fat are then separated out and reinjected using ultrasound guidance.

Pearce said there have been some trials with stem cells from bone marrow, but collecting those cells tends to be more invasive. Sanford chose fat-based stem cells because pre-clinical trials on animals showed the procedure was likely to be safe as the immune system is unlikely to attack cells from its own body.

When applied to orthopedics, fat-based stem cells also are more likely to generate tissues, such as cartilage and bone, Pearce said. Marrow cells had better luck when used to target blood and immune diseases.

Pearce said he expects the next two to three FDA approved trials of stem cell therapy for orthopedics to follow a similar format as Sanford’s current trial. After that, he predicts the efficacy will have been proven, and smaller and smaller trials will be needed to examine the use of stem cells for treatment of other types of orthopedic injuries. There is a lot of unregulated use of stem cell therapy right now, said Pearce. He expects to see more regulation in the future.