Background
Shoulder pain accounts for millions of annual clinical visits in the U.S., and rotator cuff injuries frequently lead patients to explore conservative, minimally invasive options before considering surgery. This study evaluated whether Wharton’s Jelly (WJ) allografts could supplement connective tissue defects in the shoulder for patients who had not improved with standard care.
Study Overview
A total of 87 patients across 20 private practices with rotator cuff defects were enrolled. All participants had failed at least eight weeks of conservative treatment prior to receiving a single application of a Wharton’s Jelly tissue allograft (Regenative Labs).
Methods
Patient progress was monitored over 90 days using the Numeric Pain Rating Scale (NPRS), Quality of Life Scale (QOLS), and the WOMAC index to measure pain, stiffness, and functional ability.
Results
Between baseline and Day 90, patients showed an average 59.43% improvement in NPRS scores and a 37.58% improvement in WOMAC scores. Improvements were noted across all age groups, including older adults. No adverse events were reported.
Physician Participation
Participating clinicians—including specialists in pain medicine, physical medicine and rehabilitation, and orthopedic surgery—reported that incorporating WJ allografts into their conservative care pathways offered an additional structural support option for patients with connective tissue defects in the shoulder.
Significance
Rotator cuff repairs contribute substantially to annual U.S. healthcare expenditures. This study’s findings reinforce the need for continued research into regenerative materials, including Wharton’s Jelly allografts, to better understand their role in supplementing shoulder connective tissue and supporting patient-reported improvements.
Regenative Labs leadership noted that expanding research efforts may help identify additional applications and improve understanding of tissue-specific regenerative strategies.