Abstract
Tendons have limited reparative ability and perform a relatively simple mechanical function via the extracellular matrix. Thus, the injured tendon might be treated successfully by stem cell transplantation. We performed a randomized, controlled study to investigate the effects of mesenchymal stem cell injection for treating partial tears in the supraspinatus tendon. We enrolled 24 patients with shoulder pain lasting more than 3 months and partial tears in the supraspinatus tendon. Participants were assigned to three groups: stem cells in fibrin glue, normal saline/fibrin glue mixture, and normal saline only, with which intra-lesional injection was performed. Pain at activity and rest, shoulder function and tear size were evaluated. For safety measures, laboratory tests were taken and adverse events were recorded at every visit. Participants were followed up at 6, 12 weeks, 6, 12 months and 2 years after injection. The primary outcome measure was the improvement in pain at activity at 3 months after injection. Twenty-three patients were included in the final analysis. Primary outcome did not differ among groups (p = 0.35). A mixed effect model revealed no statistically significant interactions. Only time significantly predicted the outcome measure. All participants reported transient pain at the injection site. There were no differences in post-injection pain duration or severity. Safety measures did not differ between groups, and there were no persistent adverse events. Stem cell injection into supraspinatus partial tears in patients with shoulder pain lasting more than 3 months was not more effective than control injections.ClinicalTrials.gov Identifier: NCT02298023
Highlights
The function of the tendon to transmit force generated by the muscle to the bone results in perpetual tension with or without compression and friction
The single-arm study design could not exclude the effects of natural recovery, adjunctive treatments, and the placebo effect, preventing them from making conclusions regarding the real effects of mesenchymal stem cell (MSC) injection
A comparative clinical trial is warranted to verify the clinical efficacy of MSCs in rotator cuff tears
Summary
Patients were required to have positive empty can tests, decreased elevation/internal rotation of the arm with preserved external rotation in physical examinations, and hypoechoic lesions in the supraspinatus tendon not involving full thickness of the tendon in the ultrasonographic examination later verified by MRI Those who had steroid injection within 6 weeks prior to initial evaluation; limited range of motion in multiple directions, including external rotation to rule out adhesive capsulitis; full thickness tears of the supraspinatus tendon; symptomatic calcification of the tendon; arthritis; neurogenic atrophy around the shoulder; a history of proximal humeral fracture; or infectious diseases of the affected shoulder were excluded. This study involves human participants and was approved by the Institutional review board of Seoul National University Hospital (IRB No 1404-120-575) and the Korean Ministry of Food and Drug Safety
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