Dataset Information

Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study.

ABSTRACT: 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. Subjects 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. No 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). This 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. Clinicaltrials.gov ID NCT02918136. Registered September 28, 2016, https://clinicaltrials.gov/ct2/show/NCT02918136. Level I; prospective, randomized, controlled trial.

SUBMITTER: Hurd JL

PROVIDER: S-EPMC7110715 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study.

Hurd Jason L JL Facile Tiffany R TR Weiss Jennifer J Hayes Matthew M Hayes Meredith M Furia John P JP Maffulli Nicola N Winnier Glenn E GE Alt Christopher C Schmitz Christoph C Alt Eckhard U EU Lundeen Mark M

Journal of orthopaedic surgery and research 20200330 1

<h4>Background</h4>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.<h4>Methods</h4>Subjects 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 ...[more]

PMID: 32238172

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Project description:BackgroundThe purposes of this study were to identify changes in tear dimensions, shoulder function, and glenohumeral kinematics when an asymptomatic rotator cuff tear becomes painful and to identify characteristics of individuals who develop pain compared with those who remain asymptomatic.MethodsA cohort of 195 subjects with an asymptomatic rotator cuff tear was prospectively monitored for pain development and examined annually for changes in various parameters such as tear size, fatty degeneration of the rotator cuff muscle, glenohumeral kinematics, and shoulder function. Forty-four subjects were found to have developed new pain, and the parameters before and after pain development were compared. The forty-four subjects were then compared with a group of fifty-five subjects who remained asymptomatic over a two-year period.ResultsWith pain development, the size of a full-thickness rotator cuff tear increased significantly, with 18% of the full-thickness tears showing an increase of >5 mm, and 40% of the partial-thickness tears had progressed to a full-thickness tear. In comparison with the assessments made before the onset of pain, the American Shoulder and Elbow Surgeons scores for shoulder function were significantly decreased and all measures of shoulder range of motion were decreased except for external rotation at 90° of abduction. There was an increase in compensatory scapulothoracic motion in relation to the glenohumeral motion during early shoulder abduction with pain development. No significant changes were found in external rotation strength or muscular fatty degeneration. Compared with the subjects who remained asymptomatic, the subjects who developed pain were found to have significantly larger tears at the time of initial enrollment.ConclusionsPain development in shoulders with an asymptomatic rotator cuff tear is associated with an increase in tear size. Larger tears are more likely to develop pain in the short term than are smaller tears. Further research is warranted to investigate the role of prophylactic treatment of asymptomatic shoulders to avoid the development of pain and loss of shoulder function.

Project description:PurposeTo determine whether anterior cable tears could be identified at the time of arthroscopic rotator cuff repair and determine the characteristics of the anterior cable tears identified.MethodsFrom 2016 to 2017 all shoulder arthroscopies had data collected prospectively at the time of surgery, specifically including injury to the capsular and tendon zones of insertion on the greater tuberosity. Anterior cable position and degree of injury and medialization were recorded, as well as complete findings of the diagnostic arthroscopy. The inclusion criterion was primary shoulder arthroscopy. The exclusion criterion was any revision shoulder arthroscopy. All arthroscopic rotator cuff repairs (ARCR) were grouped together and all other nonarthroscopic rotator cuff repair surgeries (non-ARCR) were grouped together.ResultsIn total, 118 shoulder arthroscopies had data collected prospectively at the time of surgery: 90 primary shoulder arthroscopies met the inclusion criteria; 28 were excluded because they were revision surgeries. There were 42 patients in the ARCR group (Group 1). Six of these were partial tears, and 36 were full-thickness tears. There were 48 patients in the non-ARCR group (Group 2). The non-ARCR Group 2 served as an anatomic baseline for ARCR Group 1. In all 90 shoulders, the rotator cable and anterior cable were identified. Group 1 (ARCR) incidence of anterior cable tears with abnormal position was 71.4% compared to 2.1% in group 2 (non-ARCR) (P < .001) Group 1 (ARCR) incidence of anterior cable tears with normal anterior cable position (n = 12) was compared to abnormal anterior cable position (n = 30). Injury to the anterior footprint capsular and tendon zones were compared. Normal anterior cable position correlated with no or low-grade injury to anterior footprint capsular zone. (Nimura zone C1). Abnormal anterior cable displacement graded as moderate (n = 20) and severe (n = 10) were compared for injury to the anterior footprint. Moderate displacement correlated with complete or high grade injury to C1 in 85% and complete injury to R1 in 45% (P < .001 and .049). In severe displacement complete C1 injury was 100%, and complete R1 injury was 100% (P < .001 and .001).ConclusionsAnterior cable tears are universally identified in ARCR. Three patterns of medial displacement severity correlated with injury to a crucial insertion zone (C1) at the anterior footprint. The degree of anterior cable disruption at the anterior footprint and displacement was commonly disproportionately greater than the injury to the supraspinatus.Level of evidenceLevel III, diagnostic study.

Dataset Information

Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study.

Publications

Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study.

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