Researchers from Hospital for Special Surgery (HSS) have been awarded an $800,000 Orthopaedic Research and Education Foundation (OREF) Clinical Research Grant in Cellular Therapy to fund a clinical trial to determine if the use of stem cell therapy can improve outcomes for patients who experience rotator cuff tears.
The grant, in honor of James Urbaniak, MD in Collaboration with National Stem Cell Foundation (NSCF), is reportedly the largest grant given in OREF history, according to a media release from Hospital for Special Surgery.
“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,” says Scott Rodeo, MD, co-principal investigator and sports medicine surgeon at HSS, per the release.
The grant will move research ahead to a phase II clinical trial to evaluate the safety and efficacy of stromal vascular fraction cells (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,” states Dr. Christopher 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 2 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, the release explains.
“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,” Rodeo adds. “We are very excited about the journey ahead.”
[Source(s): Hospital for Special Surgery, PR Newswire]