Wharton Jelly Derived-mesenchymal Stem Cells (wj-mscs) In Shoulder Overuse Injuries. Experience As An Ortho-biological Treatment

PURPOSE: To assess the safety and preliminary efficacy after Wharton Jelly-Derived MSCs (WJ-MSC) therapy for shoulder overuse injuries (SOI) including rotator cuff partial tears, long-head biceps tendinitis and impingement, bursitis and labrum injuries in a regenerative medicine centre. METHODS: A retrospective cohort was analysed. Ethical approval was obtained (CEI-0228-11-2023) following the Helsinki Declaration. Patients signed an informed consent. Athletes/patients with sports or occupational risk factors, with SOI injuries with a history of pain and functional limitation in the range of motion in one or both shoulders for more than 6 months and who failed conservative treatments were included. Allogeneic WJ-MSCs were expanded in a culture medium up to passage 7. Cell marker expression and in vitro differentiation to mesodermal lineage and microbiological tests were verified. Single WJ-MSCs dosage was delivered by ultrasound-guided injections per target shoulder: intra-articular (20x106 cells), and intratendinous (20x106 cells). Quality of life was measured by the Short-Form12. Pain was measured in rest, daily life and physical activity by Visual-Analoge-Scale (VAS). Disability was evaluated by the DASH questionnaire. Measurements were performed at baseline, 6-12 months. Response to therapy was defined as a reduction of: > = 2 points in VAS and/or > = 10 points in the DASH score. Comparisons included each score over time (baseline/6 m, baseline/12 m) with paired samples tests (t-paired or Wilcoxon W test). RESULTS: From July/2022 to August/2024, 88 patients met the eligibility criteria. The mean age was 42.36 (SD 13.85). 84% (n = 74) were men. 47/88 (53.41%) responded favourably to therapy at 6 months, and 18/25 (72%) at 12 months. The 6 and 12-month VAS were significantly reduced compared to baseline (median baseline = 5, median 6 m = 2, p < 0.001, median 12 m = 2, p < 0.001), as well as 6 and 12-month DASH (median baseline = 31.25, median 6 m = 13.33, p < 0.001, median 12 m = 11.67, p < 0,001). The 6 and 12-month SF-12 scores were significantly increased compared to baseline (median baseline = 57.14, median 6 m = 64.29, p < 0.001, median 12 m = 70.78, p = 0.008). No serious adverse events were reported. CONCLUSIONS: This study´s findings support the therapeutic benefits of WJ-MSCs in SOI patients. The therapy was safe. Supported by: This observational study was conducted under the research sources sponsored by BioXcellerator