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FDA-approved study uses adipose stem cells for treatment of shoulder injuries
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Sanford Health is conducting the first clinical trial approved by the FDA to treat injured shoulders using patients’ adipose stem cells.
“A number of studies have demonstrated that fat-derived stem cells have great healing potential by boosting the immune system and helping the natural healing process,” Jason Hurd, MD, a principal investigator of the study and orthopedic surgeon at Sanford Orthopedics & Sports Medicine in Sioux Falls, South Dakota, told Orthopedics Today. “Also, isolation of fat tissue is less invasive than isolation of other pools of stem cells, such as those found in the bone marrow, which might include a more complicated surgical procedure.”
Hurd and Mark Lundeen, MD, the other lead investigator of the study, began the trial in December to determine whether adipose stem cells, extracted from a patient’s abdominal fat, could repair partial thickness tears in the rotator cuff, according to a press release from Sanford Health. Investigators hypothesize that injecting the stem cells into the injured area could activate the patient’s body’s natural healing process, accelerate healing and regenerate tissue.
“Sanford Health physicians and scientists are the first in the country to work with the FDA on a trial using adipose stem cells in rotator cuff tears, which are common,” Kelby Krabbenhoft, president and chief executive officer of Sanford Health, said in the release. “We have been monitoring the potential of these types of stem cells for some time. In Europe, adipose stem cells have been used as a therapy option for damaged tissues and are approved to carry the CE mark, which signifies that a product has been assessed by and meets certain safety, health and environmental protection requirements in the European Union.” ‒ by Monica Jaramillo
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Disclosures: Hurd reports no relevant financial disclosures.
Perspective
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Bryan M. Saltzman, MD
Several published studies in the orthopedic literature have explored the utility of stem cells in the treatment of early osteoarthritis, tendinopathy, articular cartilage injury, meniscal repair, Achilles tendon repair, ACL reconstruction and rotator cuff repair. Recently, Jason Hurd, MD, and Mark Lundeen, MD, of Sanford Health became the principle investigators of the first FDA-approved study (open since December 2016) that investigates the use of adipose-derived stem cells for treatment of small or partial-thickness rotator cuff tears. This highlights the continued evolution of the use and study of biologics in orthopedics, as clinician-scientists work to find effective alternatives or augments to the standard treatment options of musculoskeletal injuries.
The ongoing study has the potential to address a pathology that is tremendously prevalent, clinically debilitating and currently without a perfect solution, and only time will tell if the use of adipose-derived stem cells in this setting is safe and efficacious. However, the cost associated with its use cannot be underscored and, if successful in clinical use, future study will have to evaluate its cost-effectiveness before it could become common practice.
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