Stem Cell, Fibrin Glue, and Normal Saline on Partially Torn Tendons: An RCT

Background: Tendons have limited reparative ability. With less specialized tissue characteristics, tendon injury might be one of the most promising tissues to be successfully treated 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. Methods: 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. Results: 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. Conclusions: Stem cell injection into supraspinatus partial tears in patients with shoulder pain lasting more than 3 months was not more effective than control injections. Trial Registration: ClinicalTrials.gov Identifier: NCT02298023 Funding: This research was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI17C1512) and the Bio & Medical Technology Development Program of the National Research Foundation (NRF) funded by the Korean government (MSIT) (No. 2017M3A9D8048711). Declaration of Interest: None to declare. Ethical Approval: Informed consent were approved by the institutional review board (IRB No. 1404-120-575) of our hospital and the Korean Ministry of Food and Drug Safety.