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HSS Researchers Receive Grant for Clinical Trial to Improve Outcomes for Rotator Cuff Tears

First phase II trial to test a new stem cell therapy for this condition

New York, NY—December 18, 2017

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."

The other HSS investigators are Russell F. Warren, MD; Frank A. Cordasco, MD; Hollis G. Potter, MD; Matthew F. Koff, PhD; and Ogonna Kenechi Nwawka, MD. 

 

About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S.News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

 

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