A talented team of researchers led by Scott Rodeo, M.D., and Christopher Mendias, Ph.D. at Hospital for Special Surgery (HSS) in New York has been awarded the Orthopaedic Research and Education Foundation (OREF) Clinical Research Grant in Cellular Therapy in honor of James Urbaniak, M.D. in collaboration with National Stem Cell Foundation (NSCF).
HSS Receives Largest OREF Grant in History
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The $800,000 grant—the largest in OREF history—will fund a clinical trial to determine if the use of stem cell therapy can improve outcomes for patients who suffer rotator cuff tears.
“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 in the December 18, 2017 news release.
According to 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.”
“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.”
Christopher Mendias, Ph.D., A.T.C., associate scientist at HSS and co-principal investigator, told OTW, “Now that we are moving into the phase II clinical trial, our first steps will be to finalize regulatory approvals. Then, we will be able to begin recruiting subjects into the study which is the most exciting part.”
The other HSS investigators are Russell F. Warren, M.D.; Frank A. Cordasco, M.D.; Hollis G. Potter, M.D.; Matthew F. Koff, Ph.D.; and Ogonna Kenechi Nwawka, M.D.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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