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Intratendinous Injection of Mesenchymal Stem Cells for the Treatment of Rotator Cuff Disease: A 2-Year Follow-Up Study

  • Chris Hyunchul Jo
    Correspondence
    Address correspondence to Chris Hyunchul Jo, M.D., Ph.D., Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea.
    Affiliations
    Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea

    Department of Translational Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea
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  • Jee Won Chai
    Affiliations
    Department of Radiology, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea
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  • Eui Cheol Jeong
    Affiliations
    Department of Plastic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea
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  • Sohee Oh
    Affiliations
    Department of Biostatistics, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea
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  • Kang Sup Yoon
    Affiliations
    Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea
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Published:December 03, 2019DOI:https://doi.org/10.1016/j.arthro.2019.11.120

      Purpose

      To assess the mid-term safety and efficacy of an intratendinous injection of autologous adipose tissue–derived mesenchymal stem cells (AD MSCs) for rotator cuff disease at 2-year follow-up.

      Methods

      The first part of the study consisted of 3 dose-escalation groups, with 3 patients each, for the evaluation of safety: low-dose (1.0 × 107 cells), mid-dose (5.0 × 107), and high-dose (1.0 × 108) groups. For the second part, we planned to include 9 patients receiving the high dose for the evaluation of exploratory efficacy. Clinical outcomes were assessed according to pain, range of motion, muscle strength, functional scores, overall satisfaction and function, and presence of failure. Structural outcomes included changes in volume of tendon defects measured using magnetic resonance imaging.

      Results

      This study enrolled 19 patients (9 for the first part and 10 for the second part) with partial-thickness rotator cuff tears. There were no treatment-related adverse events at minimum 2-year follow-up. Intratendinous injection of AD MSCs reduced shoulder pain by approximately 90% at 1 and 2 years in the mid- and high-dose groups. The strength of the supraspinatus, infraspinatus, and teres minor significantly increased by greater than 50% at 2 years in the high-dose group. Shoulder function measured with 6 commonly used scores improved for up to 2 years in all dose groups. Structural outcomes evaluated with magnetic resonance imaging showed that the volume of bursal-sided defects in the high-dose group nearly disappeared at 1 year and did not recur at up to 2 years. No failures—defined as the performance of any kind of shoulder surgery or return of the Shoulder Pain and Disability Index score to the preinjection level—occurred during follow-up.

      Conclusions

      This study showed continued safety and efficacy of an intratendinous injection of AD MSCs for the treatment of partial-thickness rotator cuff tears over a 2-year period through regeneration of tendon defects.

      Level of Evidence

      Level III, retrospective comparative study.
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