Researchers at Sanford Health want to know whether stems cells from abdominal fat can help with shoulder injuries. An FDA-approved trial is in the works with 18 patients between Sioux Falls and Fargo, North Dakota. Meet the first patient enrolled in the study, find out how it works, and hear an in-depth conversation with Sanford's Chief Medical Officer Dr. Allison Suttle about what the clinical results may reveal.
"I really don’t know what I did," Mike Duncan says.
His shoulders hurt. Duncan's doctor discovered a problem with the right shoulder and fixed it with surgery. When the physician examined Duncan’s left shoulder, he found a tear in the rotator cuff.
"Over the past year, maybe year and a half, it really got to the point where going way above my head or trying to tuck my shirt in in the back or reaching behind my back or behind into a car seat – I just couldn’t do it because of the pain," Duncan says.
That pain could go away during a clinical trial at Sanford Research. Patients either get stem cells or steroids. Duncan’s already had his injection, but he’s not telling what he received. It could damage the study.
"I know what I got, because there’s the two different arms," Duncan says. "One is a simple steroid injection that you go in and they just put a needle in your shoulder and inject the steroid. The other one is a little more in-depth where they would actually do liposuction on your abdomen and then extract the stem cells and then inject that. So, yeah, the two arms are totally different versus just going to the research office and getting a bottle that says ‘research medication’ and not knowing which one it is."
Duncan is director of pharmacy at Sanford USD Medical Center. He’s been involved in approving and conducting clinical trials. He says he understands the importance of keeping staff members blind to which patients receive which treatments, and he has the abdominal binder to prove it.
"The liposuction takes place on your abdomen, and there can be bruising with liposuction, so every patient – whether you get the steroid injection or you get the liposuction – will wear an abdominal binder for the first few visits," Duncan says.
"It kind of looks like a Velcro corset," Jennifer Weiss says.
Weiss is a project manager with clinical research and regenerative medicine. She describes some of the materials necessary for removing fat from a patient’s midsection.
"So we have a big plastic bag of different types of surgical equipment just varying from sterile drapes, varying syringes, a scalpel, some liquid stitches, different needles," Weiss says. "But essentially they harvest the lipoaspirate – or the fat – with a syringe and a really long cannula, or another way to say that would be blunt needle, but after they’ve numbed the abdominal area."
Scientists process that fat – about half a cup – before it gets back to the patient.
"The plastic surgeon will hand the research team the tubes of the fat, and the research team has been very well trained on how to process that fat to pull out the stem cells, and the end result is a small syringe that actually gets injected by an orthopedic physician’s assistant under ultrasound-guided injection into the rotator cuff tear," Weiss says.
Weiss emphasizes that the study is randomized. No one at Sanford gets to choose the treatment patients receive. A computer assigns steroids or stem cells to patients.
"It’s important to remember that, just because participation in the trial may not help you, it may help someone in the future," Weiss says. "So even if you don’t get the sexy intervention, you could help other patients in the future have access to that if it does become FDA approved."
The first patient enrolled in the research, Mike Duncan, says he sees the benefits to both treatments.
"If I get the stem cell injection and it works, that would be great and I might not need surgery. If I get the steroid injection, I could potentially buy some time for surgery," Duncan says. "Again I’m still rehabbing my right shoulder a little bit, so it could buy me some time and maybe through this summer I could ride my motorcycle a little more, maybe do some paddle boarding and kayaking."
Duncan says he has more than a year to consider what’s next for his left shoulder. The clinical trial concludes in 2018.