评估冷冻保存的人脐带同种异体组织移植增强膝骨关节炎患者功能和疼痛结局的疗效:一项观察性数据收集研究

Justine M. Davis, M. Sheinkop, Tyler C. Barrett
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引用次数: 1

摘要

本研究的主要目的是报告使用冷冻保存的人脐带组织异体移植物补充膝关节负重关节软骨症状性退变患者的初步疗效数据。我们的主要终点是疼痛、僵硬和功能恢复评分。在这项正在进行的研究中,55名参与者(56-93岁)接受了一次沃顿氏果冻组织异体移植。研究剂量为150mg Wharton’s jelly同种异体移植物悬浮于约2ml 0.9%无菌氯化钠溶液(生理盐水)中。每个研究都是在医生办公室的超声指导下进行的。研究方法包括数值疼痛评定量表(NPRS)评分和西安大略和麦克马斯特大学骨关节炎指数(WOMAC)分段评分,包括疼痛、僵硬和身体功能。研究入组55例患者,应用后随访90天。无不良事件或不良反应报告。结果显示,与90天的初始检查相比,NPRS和WOMAC在统计学上有显著改善。数据表明,Wharton的果冻组织同种异体移植应用于有症状的膝关节骨关节炎患者是安全的、非手术的和有效的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of the Efficacy of Cryopreserved Human Umbilical Cord Tissue Allografts to Augment Functional and Pain Outcome Measures in Patients with Knee Osteoarthritis: An Observational Data Collection Study
The primary objective of this study is to report the initial efficacy data observed with the use of cryopreserved human umbilical tissue allografts for supplementation in patients with symptomatic degeneration of load-bearing articular cartilage in the knee joint. Our primary endpoints were pain, stiffness, and functional recovery scores. In this ongoing study, 55 participants (age 56–93 years) received a single Wharton’s jelly tissue allograft application. The study dose consisted of 150 mg of Wharton’s jelly allograft suspended in approximately 2 mL of sterile sodium chloride 0.9% solution (normal saline). Each study knee application was performed under ultrasound guidance in a physician’s office. The research methodology consisted of Numeric Pain Rating Scale (NPRS) scores and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subsection scores including pain, stiffness, and physical function. Study enrollment consisted of 55 patients followed for a post-application duration of 90 days. No adverse events or adverse reactions were reported. The results demonstrated statistically significant improvements of NPRS and WOMAC in initial versus 90-day examination. The data represent Wharton’s jelly tissue allograft applications are safe, non-surgical, and efficacious for patients with symptomatic osteoarthritis of the knee.
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