Abstract
BackgroundThis study tested the hypothesis that treatment of symptomatic, partial-thickness rotator cuff tears (sPTRCT) with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated from lipoaspirate at the point of care is safe and more effective than corticosteroid injection.MethodsSubjects aged between 30 and 75 years with sPTRCT who did not respond to physical therapy treatments for at least 6 weeks were randomly assigned to receive a single injection of an average 11.4 × 106 UA-ADRCs (in 5 mL liquid; mean cell viability: 88%) (n = 11; modified intention-to-treat (mITT) population) or a single injection of 80 mg of methylprednisolone (40 mg/mL; 2 mL) plus 3 mL of 0.25% bupivacaine (n = 5; mITT population), respectively. Safety and efficacy were assessed using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), RAND Short Form-36 Health Survey, and pain visual analogue scale (VAS) at baseline (BL) as well as 3 weeks (W3), W6, W9, W12, W24, W32, W40, and W52 post treatment. Fat-saturated T2-weighted magnetic resonance imaging of the shoulder was performed at BL as well as at W24 and W52 post treatment.ResultsNo severe adverse events related to the injection of UA-ADRCs were observed in the 12 months post treatment. The risks connected with treatment of sPTRCT with UA-ADRCs were not greater than those connected with treatment of sPTRCT with corticosteroid injection. However, one subject in the corticosteroid group developed a full rotator cuff tear during the course of this pilot study. Despite the small number of subjects in this pilot study, those in the UA-ADRCs group showed statistically significantly higher mean ASES total scores at W24 and W52 post treatment than those in the corticosteroid group (p < 0.05).DiscussionThis pilot study suggests that the use of UA-ADRCs in subjects with sPTRCT is safe and leads to improved shoulder function without adverse effects. To verify the results of this initial safety and feasibility pilot study in a larger patient population, a randomized controlled trial on 246 patients suffering from sPTRCT is currently ongoing.Trial registrationClinicaltrials.gov ID NCT02918136. Registered September 28, 2016, https://clinicaltrials.gov/ct2/show/NCT02918136.Level of evidenceLevel I; prospective, randomized, controlled trial.
Highlights
This study tested the hypothesis that treatment of symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-Adipose-derived regenerative cells (ADRCs)) isolated from lipoaspirate at the point of care is safe and more effective than corticosteroid injection
The risks connected with treatment of sPTRCT with UA-ADRCs were not greater than those connected with treatment of sPTRCT with corticosteroid injection
Partial-thickness rotator cuff tear with UA-ADRCs Table 5 provides a detailed overview on all treatment emergent adverse events (TEAEs) that were reported during the course of this pilot study (coded with the Medical Dictionary for Regulatory Activities (MedDRA) Version 19.1 [45])
Summary
This study tested the hypothesis that treatment of symptomatic, partial-thickness rotator cuff tears (sPTRCT) with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated from lipoaspirate at the point of care is safe and more effective than corticosteroid injection. Partial-thickness rotator cuff tears (PTRCT) are a common cause of shoulder pain, loss of function, and occupational disability [1,2,3] They are classified according to location (articular, bursal, interstitial), grade (grade 1, < 3 mm deep; grade 2, 3–6 mm deep; grade 3, > 6 mm deep), and tear area [4]. According to the Guideline on Optimizing the Management of Rotator Cuff Problems of the American Academy of Orthopedic Surgeons [9, 10], the strength of recommendation for or against many nonoperative treatment options for rotator cuff tears and rotator cuff-related symptoms (including activity modification, exercise programs, use of nonsteroidal anti-inflammatory drugs, and corticosteroid injections) has remained “inconclusive,” with no differentiation between bursal-sided and articular-sided PTRCT. Arthroscopic repair of bursal-sided and articular-sided PTRCT showed similar functional outcome and the same retear rate (approximately 10% during the first two years after surgery) [17, 18]
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