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NCT02484950

Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair

Completed NA Results posted Last updated 28 July 2025
What this trial tests

NA trial testing Mesenchymal stem cell augmentation in rotator cuff repair in Full Thickness Rotator Cuff Tear in 62 participants. Completed in 27 June 2024.

Timeline
15 November 2015
Primary endpoint
1 May 2024
27 June 2024

Quick facts

Lead sponsorRush University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment62
Start date15 November 2015
Primary completion1 May 2024
Estimated completion27 June 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rush University Medical Center

Who can join

Adults 18 to 70, any sex, with Full Thickness Rotator Cuff Tear. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

American Shoulder and Elbow Surgeons (ASES) Score Primary · One year

The American Shoulder and Elbow Surgeons (ASES) score is a patient-reported score that measures shoulder pain, activity level and stability. The score ranges from 0 to 100, with higher scores indicating better shoulder function. Excellent: 90-100 points Good: 70-89 points Fair: 40-49 points Poor: Less than 39 points

GroupValue95% CI
Rotator Cuff Repair With Stem Cells870 – 100
Rotator Cuff Repair Without Stem Cells890 – 100

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mesenchymal Stem Cells Empowering Tendon Regenerative Therapies.
    Costa-Almeida R, Calejo I, Gomes ME. · · 2019 · cited 102× · PMID 31248196 · DOI 10.3390/ijms20123002
  2. Mechanism of Action of Mesenchymal Stem Cells (MSCs): impact of delivery method.
    Bagno LL, Salerno AG, Balkan W, Hare JM. · · 2022 · cited 49× · PMID 34882517 · DOI 10.1080/14712598.2022.2016695
  3. Prospective Randomized Trial of Biologic Augmentation With Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair.
    Cole BJ, Kaiser JT, Wagner KR, Sivasundaram L, et al · · 2023 · cited 37× · PMID 36811557 · DOI 10.1177/03635465231154601
  4. Mechanotransduction of stem cells for tendon repair.
    Wang HN, Huang YC, Ni GX. · · 2020 · cited 22× · PMID 33033557 · DOI 10.4252/wjsc.v12.i9.952
  5. Cell-Based Therapies for Rotator Cuff Injuries: An Updated Review of the Literature.
    Hooper N, Marathe A, Jain NB, Jain NB, et al · · 2024 · cited 10× · PMID 38542113 · DOI 10.3390/ijms25063139
  6. Implementation of Endogenous and Exogenous Mesenchymal Progenitor Cells for Skeletal Tissue Regeneration and Repair.
    Desai S, Jayasuriya CT. · · 2020 · cited 8× · PMID 32759659 · DOI 10.3390/bioengineering7030086
  7. State-of the-art and future perspective in co-culture systems for tendon engineering.
    Guillaumin S, Rossoni A, Zeugolis D. · · 2025 · cited 2× · PMID 40130022 · DOI 10.1016/j.bbiosy.2025.100110
  8. Epigenetic mechanisms in stem cell therapies for achilles tendinopathy.
    Yuan Z, Yao Z, Mao X, Gao X, et al · · 2025 · PMID 40181824 · DOI 10.3389/fcell.2025.1516250

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