CompletedNot Applicable

Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair

United States62 participantsStarted 2015-11-15

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient is determined to have a full thickness rotator cuff tear (1-3 cm) or partial tear converted to a full-thickness tear-on the pre-operative MRI scan or found arthroscopically-and is scheduled to undergo surgical repair * Written informed consent is obtained Exclusion Criteria: * Revision surgery * Irreparable tear or partial repair * Any patient lacking decisional capability * Subscapularis involvement

What they're measuring

American Shoulder and Elbow Surgeons (ASES) Score

Timeframe: One year

Trial details

NCT IDNCT02484950

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-01

Results submitted2025-01-09

View on ClinicalTrials.gov More Full Thickness Rotator Cuff Tear trials