Sanford starts historic stem cell trial
A first-of-its kind clinical trial has started at Sanford Health, using stem cells to help treat rotator cuff tears.
Patients have started to be screened for the trial, which will involve treating 12 people with stem cells and measuring their improvement compared to six people who receive a cortisone shot.
The approach is one pioneered by Dr. Eckhard Alt in Germany, where Sanford has a portal clinic.
He extracts stem cells from a patient’s abdominal fat, treats them with a proprietary enzyme mixture and then uses imaging to inject the non-manipulated cells as close as possible to the area being treated.
The idea is that the stem cells then will help the surrounding tissue and cartilage regenerate.
The Sanford trial will be the first to use stem cells derived from abdominal fat, Sanford leaders said,
“The vision I have is that Sanford will legitimize the use of stem cells,” said Dr. David Pearce, president of Sanford Research. “There’s so much out there in terms of questions. Is this the right thing? Are they safe? We’re going to be taking the lead.”
The FDA clinical trial is first designed to show the procedure is safe.
Alt, who estimates he has treated 200 human orthopedic patients in the last few years along with hundreds of dogs and horses, said he has not seen any adverse effects. It also has been proven safe in European trials.
“People ask me, ‘Is it going to work?’ We say, ‘We hope so and we have good indications from previous patients.’ But worst case is it’s a lower effect that we expect,” he said. “We have not harmed anybody. And the odds it works are very, very high.”
His patients include professional athletes, including one who went on to play a PGA tournament after having to give up professional golf because of injuries, Alt said.
Sanford chose to start with treating rotator cuff injuries because they are common.
Dr. Jason Hurd, an orthopedic surgeon and sports medicine physician at Sanford Orthopedics & Sports Medicine, will be one of the trial’s principal investigators. He, Pearce and other physicians from Sanford are traveling to Germany in March to observe the procedure there.
“It’s been great, the collaborations we’ve had between the research teams and the clinicians here to look into stem cells as a way to treat some of the orthopedic disorders we see every day,” Hurd said. “It’s an exciting time.”
Rotator cuff tears are “probably the most common problem we see in my practice,” Hurd said. “And it affects a broad range of patients and causes a lot of problems for people.”
Once the patients are chosen for the procedure, they will have their abdominal fat stem cells withdrawn from an area of their choice. It’s not enough to make any visible difference in the patients’ appearance, though.
Then the stems cells will be injected into the rotator cuff.
“It’s a very short procedure. You’ll be out in two or three hours,” Pearce said.
After that patients will be monitored through range of motion tests and imaging to determine how the stem cell treatment is working and to ensure there are no adverse effects. Any effects that do emerge will be reported.
“I think the patients are going to say they feel better very quickly, but that’s a placebo effect. We have to go by the imaging,” Pearce said. “And the range of motion. So that’s going to be in the physicians’ hands for the follow-up and it could be anywhere from six to 12 months. It depends.”
Once initial safety findings are provided to the FDA, Sanford would move into proving the treatment is effective and then begin offering it to more patients in a larger trial.
Assuming the FDA ultimately signs off, the process could be commonly offered to patients in a couple years.
Sanford’s goal then is to expand the approach to treating other orthopedic injuries and conditions such as non-healing wounds.
“Once we show the safety we’re hopeful we get the green light to move to the next level, and there’s no reasons to suspect we wouldn’t,” Pearce said. “We’re trail blazing in showing how you can do this.”