Sanford Health, a non-profit, integrated health system based in South Dakota, recently announced that they have announced the first patient treated into the osteoarthritis-focused, multi-center MILES clinical trial sponsored by Emory University. The use of stem cell therapy may progress how we treat osteoarthritis.
The MILES study is a national research project exploring the use of adult stem cells to treat osteoarthritis of the knee. Stanford is participating in the nearly $14 million effort by Emory University (sponsor), Duke University and the Andrew Research Education Foundation to identify a superior source of stem cells for treating osteoarthritis.
Details of the Study
The MILES study multicenter trial conducted to compare the effectiveness of corticosteroid control to mesenchymal stem cell preparations from autologous bone marrow concentrate (BMAC), adipose-derived stem cells in the form of Stromal Vascular Fraction (SVF), and third party human mesenchymal stem cells manufactured from umbilical cord tissue (UCT) for the treatment of unilateral Knee Osteoarthritis (OA). The study is being conducted in the United States, including the sponsor Emory University. A total of 480 patients will be targeted for enrollment in the study.
Sanford Health Treats Lindsey Leach
Sanford Health is one of the clinical investigational sites participating in the MILES study. Lindsay Leach is the first patient to be treated at Sanford in Fargo, ND. She has faced an ongoing battle with osteoarthritis in her knew over the last half-decade. She has struggled as the pain severity may vary but when the bad days are bad she reports “I’m very, very stiff (and) I have a lot of significant pain.” Ms. Leach represents one of 120 patients in Fargo and Sioux Falls participating in the randomized single-blind clinical trial.
Sanford’s Clinical Investigator
Dr. Benjamin Noonan, a Sanford orthopedic surgeon, explained that the researchers are studying different kinds of stem cells: those derived from a patient’s own bone marrow; another using fat and a third from donated umbilical cord tissue. The investigators seek to understand if the stem cells can make patients feel less pain or regrow cartilage in their knees reports Inforum.
Dr. Noonan reports “We draw these cells out. We have a lab downstairs where we count them (and) we send them off to be characterized so we’re going to know exactly where we’re giving.” A key element in this study reports Noonan is that the patents are unaware if they are receiving an injection of stem cells or cortisone.
The Results in the Future
The results of the study are anticipated in three years. The fundamental investigational question is where the treatment works and which type of stem cells work best is something investigators will publish when MILE is complete.
Scott D. Bowden, MD, Emory University
Call to Action: If you have osteoarthritis in the knee this study may be of interest. TrialSite News concierge service can connect you—also sign up for our newsletter for any updates.