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Clinical Spotlight: New Trial to Test Stem Cells for Rotator Cuff Repair

Dec 28, 2016 12:30PM ● By MED Magazine
Last month, Sanford opened a first-of-its kind FDA-approved clinical trial to treat rotator cuff tears with a patient’s own adipose-derived stem cells. The goal is to determine whether an injection of these cells can safely repair small and partial thickness tears by activating the body’s natural healing process.

Orthopedic surgeons Jason Hurd, MD, of Sioux Falls and Mark Lundeen, MD, of Fargo are the 
 study’s two principal investigators. MED spoke with Dr. Hurd about this common type of shoulder injury and the significance of the new trial.

Dr. Hurd: The problem with rotator cuff injuries is that, in contrast to other types of injuries, they do not spontaneously heal on their own.  Several studies following patients with rotator cuff tears suggest that, in some patients, small tears even progress and get bigger. If 50 percent of your rotator cuff is torn, it is going to cause pain and discomfort.

MED: How are these types of injuries typically treated?
Dr. Hurd: A lot of times we perform surgery to try to get them to heal. We go in and reattach the tendon to the bone with anchors and sutures. The goal is to try to get it to heal back to the bone.

MED: What do you hope that the adipose stem cells will do for rotator cuff tears?
Dr. Hurd: Because the tendon is still in proximity to the bone, we want to see if injecting the patient’s own stem cells into this area will help the body heal naturally. We don’t know yet whether this is going to work, but we want to find out.

MED: Why are you using adipose-derived cells?
Dr. Hurd: There are several reasons. For one, these cells are easy to get and almost everyone has some. The process is also less painful for patients than taking stem cells from bone marrow. Using enzymes to concentrate these adipose stem cells into a solution, we are able to use them within an hour or two of harvesting.

MED: Why is this trial significant?
Dr. Hurd: We are good at mechanically fixing rotator cuff tears, but we know that that is only part of the process. To get healing to happen, we have to improve the biology. You can fix the tear as well as you want, but if the patient’s own body does not heal it back to the bone, the repair will never really be what you want it to be. It is very exciting to be the first to test this method.

About the trial: This year-long trial, which began in December, will include 18 patients. Twelve patients will receive stem cell injections and six controls will receive cortisone shots. Patients will be monitored with an MRI at baseline, six months, and one year after the procedure and will undergo a progress therapy regimen. This trial, which was developed in conjunction with the FDA,  is the first and only FDA-approved clinical trial testing the safety and efficacy of adipose stem cells for this type of injury.