Sanford Health has launched a clinical trial to determine whether a patient’s own stem cells can help mend partial rotator cuff tears.
The clinical trial uses stromal vascular fraction, a mixture of cells and nutrients isolated from a patient’s stomach fat. These adipose derived stem cells are then injected into the rotator cuff area in need of repair.
“For patients in the trial there is no efficacious treatment, only steroids. That’s where cells come in. There is evidence that they will accelerate healing, but through a mechanism that remains elusive,” says Daniel Kota, assistant research scientist at Sioux Falls, South Dakota based Sanford Research, part of Sanford Health.
Sanford has just begun to enroll patients into the clinical trial. Once the safety of the cell infusion is determined, the researchers will see if the therapy works and if the results are reproducible.
They also hope that their work will answer some of the scientific questions surrounding stem cell therapy, such as where the cells go after infusion, and provide best practices and standards regarding their use, says Jill Weimer, PhD, another researcher involved in the study.
While the Food and Drug Administration (FDA) only allows the use of these stem cells as part of a clinical trial, other countries are more lenient, a concern the Sanford researchers pointed out in an article in the latest issue of Stem Cells Translational Medicine. Some physicians in the United States are injecting these stem cells in clinical practice without FDA approval and without full knowledge of their effects, with sometimes adverse results, says Kota.
“There is no consensus what to call these cells, what’s in them and what they’re doing to help healing,” says Kota. The information could dictate different therapies. For instance, the composition of the “cocktail” of cells left after the fat cells are removed will be different for each patient, which could affect how much to inject.
“Trials have to be done in a way that’s safe because that leads to effective treatment. We need to be the pioneers and ask the important questions,” Weimer says.
These answers are becoming more imperative as this field is quickly changing.
“Adult stem therapy is coming. It’s just a matter of time. The question is what kind of stem cells we’re talking about,” says Kota.