Working Paper Article Version 2 This version is not peer-reviewed

Safety and Efficacy of Treating Symptomatic, Partial-Thickness Rotator Cuff Tear 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

Version 1 : Received: 23 December 2019 / Approved: 25 December 2019 / Online: 25 December 2019 (07:06:48 CET)
Version 2 : Received: 12 February 2020 / Approved: 14 February 2020 / Online: 14 February 2020 (05:05:43 CET)

How to cite: Hurd, J.L.; Facile, T.R.; Weiss, J.; Hayes, M.; Hayes, M.; Furia, J.P.; Maffulli, N.; Winnier, G.E.; Alt, C.; Schmitz, C.; Alt, E.U.; Lundeen, M.A. Safety and Efficacy of Treating Symptomatic, Partial-Thickness Rotator Cuff Tear 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. Preprints 2019, 2019120337 Hurd, J.L.; Facile, T.R.; Weiss, J.; Hayes, M.; Hayes, M.; Furia, J.P.; Maffulli, N.; Winnier, G.E.; Alt, C.; Schmitz, C.; Alt, E.U.; Lundeen, M.A. Safety and Efficacy of Treating Symptomatic, Partial-Thickness Rotator Cuff Tear 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. Preprints 2019, 2019120337

Abstract

Background: This study tested the hypothesis that treatment of symptomatic, partial-thickness rotator cuff tear (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. Methods: Subjects aged between 30 and 75 years with sPTRCT who did not respond to physical therapy treatments for at least six 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 three 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. Results: 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). Discussion: 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.

Subject Areas

adipose-derived regenerative cells; ADRCs; partial rotator cuff tear; stem cells; stromal vascular fraction

Comments (1)

Comment 1
Received: 14 February 2020
Commenter: Jason Hurd
Commenter's Conflict of Interests: Author
Comment: Numerous modifications to manuscript based on reviewers comments
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