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同种异体间充质基质细胞与高分子量透明质酸关节腔内注射治疗犬骨关节炎:一项双盲、随机、前瞻性临床试验的探索性数据

Intra-Articular Injections of Allogeneic Mesenchymal Stromal Cells vs. High Molecular Weight Hyaluronic Acid in Dogs With Osteoarthritis: Exploratory Data From a Double-Blind, Randomized, Prospective Clinical Trial.

作者信息

Kim Sohyun, Elam Lindsay, Johnson Valerie, Hess Ann, Webb Tracy, Dow Steven, Duerr Felix

机构信息

Department of Clinical Sciences, Colorado State University College of Veterinary Medicine and Biomedical Sciences, Fort Collins, CO, United States.

Department of Statistics, Colorado State University, Fort Collins, CO, United States.

出版信息

Front Vet Sci. 2022 Jun 7;9:890704. doi: 10.3389/fvets.2022.890704. eCollection 2022.

DOI:10.3389/fvets.2022.890704
PMID:35747237
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9209755/
Abstract

This double-blind, randomized, prospective clinical trial was conducted to obtain exploratory data comparing the efficacy of intra-articular allogeneic mesenchymal stem/stromal cells (MSC) to high molecular weight hyaluronic acid (HA) for the treatment of pain associated with canine osteoarthritis (OA). Objective gait analysis (%Body Weight Distribution, %BWD), accelerometry, clinical metrology instruments and veterinary exams were used as outcome measures during various time points throughout the 48-week study period. Fourteen dogs with elbow or coxofemoral OA were enrolled and assigned in a 2:1 ratio to the treatment groups. Each patient received a set of two injections 4 weeks apart. Self-limiting joint flare was observed in seven patients, with six of these in the MSC group. Ten patients completed all follow-up appointments. Both treatment groups showed evidence of mild improvement following the treatment, but the results were inconsistent among the various outcome measures assessed. Overall, dogs enrolled in the HA group showed greater improvement compared to the MSC group. The primary outcome measure, %BWD, showed evidence of improvement, when compared to baseline values, at 36 weeks after injection for the HA group only ( = 0.048, estimated difference: 4.7). Similarly, when treatment groups were compared, evidence of a difference between treatment groups (with the HA-group showing greater improvement) were identified for weeks 24 and 36 ( = 0.02 and 0.01, respectively). The small sample size of this exploratory study does not allow firm conclusions. However, until studies with larger sample sizes are available, the current literature combined with our data do not support the clinical use of intra-articular MSC therapy over high molecular weight HA for the treatment of canine OA at this time.

摘要

本双盲、随机、前瞻性临床试验旨在获取探索性数据,比较关节内注射同种异体间充质干/基质细胞(MSC)与高分子量透明质酸(HA)治疗犬骨关节炎(OA)相关疼痛的疗效。在为期48周的研究期间的不同时间点,使用客观步态分析(体重分布百分比,%BWD)、加速度测量、临床计量仪器和兽医检查作为结局指标。纳入14只患有肘或股髋关节炎的犬,并以2:1的比例分配到治疗组。每只犬每隔4周接受一组两次注射。7只犬出现自限性关节炎症,其中6只在MSC组。10只犬完成了所有随访预约。两个治疗组在治疗后均显示出轻度改善的迹象,但在评估的各种结局指标中结果不一致。总体而言,与MSC组相比,纳入HA组的犬改善更大。主要结局指标%BWD仅在HA组注射后36周与基线值相比显示出改善迹象(P = 0.048,估计差异:4.7)。同样,在比较治疗组时,在第24周和第36周发现治疗组之间存在差异的迹象(分别为P = 0.02和0.01,HA组改善更大)。这项探索性研究的样本量较小,无法得出确凿结论。然而,在有更大样本量的研究可用之前,目前的文献结合我们的数据目前不支持在治疗犬OA时关节内MSC治疗优于高分子量HA的临床应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ca/9209755/c7ad2e1eba41/fvets-09-890704-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ca/9209755/4dcb575fd719/fvets-09-890704-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ca/9209755/c7ad2e1eba41/fvets-09-890704-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ca/9209755/4dcb575fd719/fvets-09-890704-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ca/9209755/c7ad2e1eba41/fvets-09-890704-g0002.jpg

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