At a glance
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A Prospective Randomized Trial of Biologic Augmentation With Mesenchymal Stem Cells in Patients Undergoing Arthroscopic Rotator Cuff Repair
In Brief
A clinical study evaluating Mesenchymal stem cell augmentation in rotator cuff repair and Standard arthroscopic rotator cuff repair for Full Thickness Rotator Cuff Tear. Completed, enrolled 62 participants across 1 site.
Detailed Summary
The primary objective of this study is to compare the clinical outcomes of arthroscopic rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs). Mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines and by supplying growth factors to their implanted environment. They have been shown to be effective in improving both overall healing and tendon integrity in rotator cuff repair. This study will follow 100 patients in the United States and track their clinical outcomes for at least one year post-operatively.
Study Details
Timeline
Interventions
Patients undergoing mesenchymal stem cell augmentation will receive a total injection of 6 milliliters (mL). Of this, 3 mL will be injected in the tendon at the junction between bone and tendon, while 3 mL will be injected in the bone at the site of the surgical footprint.
All patients will undergo full thickness rotator cuff repair using a double row, transosseous-equivalent (TOE) repair with anchor/suture technique. Acromioplasty will be performed in all patients. Alternate procedures such as biceps tenotomy/tenodesis and distal clavicle excision will be performed at the discretion of the surgeon and recorded.