N/A
Completed N=62
Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair
Full Thickness Rotator Cuff Tear
Source: ClinicalTrials.gov NCT02484950 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: American Shoulder and Elbow Surgeons (ASES) Score — 87; 89 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American Shoulder and Elbow Surgeons (ASES) Score |
87; 89 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02484950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.