A multidisciplinary team led by Scott Rodeo, MD, and Christopher Mendias, PhD, at Hospital for Special Surgery (HSS) has been awarded the Orthopaedic Research and Education Foundation (OREF) Clinical Research Grant in Cellular Therapy in honor of James Urbaniak, MD in Collaboration with National Stem Cell Foundation (NSCF). The $800,000 grant will fund a clinical trial to determine if the use of stem cell therapy can improve outcomes for patients who suffer rotator cuff tears. To date, this is the largest grant given in OREF history.
Rotator cuff tears are one of the most prevalent musculoskeletal conditions yet surgical repair does not reverse muscle atrophy so patients may continue to feel weakness and pain even after surgery.
While surgical techniques have evolved over the years, there is still a high re-tear rate, which warrants more research to identify a better solution.
"The results of rotator cuff repair surgery are adversely affected by muscle atrophy and weakness, making it difficult for many patients to return to full function," said Dr. Rodeo, co-principal investigator and sports medicine surgeon at HSS.
Previous studies have shown that stem cells that are harvested from body fat in the abdominal and thigh area can improve the regeneration of musculoskeletal tissues. These cells, known as stromal vascular fraction cells (SVFCs), contain a population of pluripotent stem cells that can differentiate into skeletal muscle and tendon tissue. These cells also secrete anti-inflammatory and tissue regeneration molecules.
The grant will move research ahead to a phase II clinical trial to evaluate the safety and efficacy of SVFCs in improving outcomes for patients who undergo arthroscopic surgical repair for rotator cuff tears.
"This study may be the first to determine if stem cells from a patient's own adipose tissue can improve outcomes after rotator cuff repair," said Dr. Mendias, co-principal investigator and associate scientist at HSS. "We believe that the patients who receive SVFCs may see improved function and demonstrate improved tissue healing on both clinical imaging and tissue histological studies."
Over 50 patients will be enrolled in the study, with HSS following patients for two years to track strength and range of motion measurements, imaging assessments of muscle and tendon regeneration, and patient-reported outcome scores. In order to evaluate return to normal function, the primary outcome measure will be shoulder strength.
"If we demonstrate that this cell therapy is successful, then there is a clear justification for a pivotal phase III clinical trial in patients with rotator cuff tears," added Dr. Rodeo. "We are very excited about the journey ahead."