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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Article info
Publication history
Published online: December 03, 2019
Accepted:
November 17,
2019
Received:
July 12,
2019
See commentary on page 981Footnotes
The authors report the following potential conflicts of interest or sources of funding: This research was supported by a grant (HI14C2748) from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute and by the Basic Science Research Program and Bio & Medical Technology Development Program of the National Research Foundation of Korea, funded by the Ministry of Science, ICT & Future Planning (NRF-2015M3A9E6028412 and NRF-2017R1A2B2010995). C.H.J. receives research grants from Korea Health Industry Development Institute and National Research Foundation of Korea. Full ICMJE author disclosure forms are available for this article online, as supplementary material.
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© 2019 by the Arthroscopy Association of North America
