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在一家三级炎症性肠病中心,患者对早期细胞治疗临床试验的参与度和满意度。

Patient engagement and satisfaction with early phase cell therapy clinical trials at a tertiary inflammatory bowel disease center.

机构信息

Department of General Surgery, Digestive Disease Surgical Institute, Cleveland Clinic, Cleveland, OH 44195, USA.

Division of General Surgery, Scripps Clinic Medical Group, Scripps Health, La Jolla, CA 92037, USA.

出版信息

Stem Cell Reports. 2024 Apr 9;19(4):435-442. doi: 10.1016/j.stemcr.2024.02.008. Epub 2024 Mar 28.

DOI:10.1016/j.stemcr.2024.02.008
PMID:38552633
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11096429/
Abstract

Several clinical trials are underway investigating cell and gene therapy, and while these trials are meant to significantly impact patient care, they rely on patient engagement and participation. Unfortunately, clinical trials generally require extensive commitment by subjects. While several studies are using validated surveys to measure patient-reported outcomes, there is a lack of characterization of the patient experience as a subject in these trials. As such, we surveyed mesenchymal stromal cell (MSC) trial participants to understand their perspective. We found that there exists a reliance on one's gastroenterologist and colorectal surgeons for trial introduction and that time and cost were the main barriers to participation. Overall, participants demonstrated high satisfaction with MSC trial participation, but future protocols could incorporate increased use of virtual appointments to optimize patient experience.

摘要

正在进行几项细胞和基因治疗的临床试验,虽然这些试验旨在对患者护理产生重大影响,但它们依赖于患者的参与和配合。不幸的是,临床试验通常需要受试者做出大量承诺。虽然有几项研究正在使用经过验证的调查来衡量患者报告的结果,但缺乏对这些试验中患者体验作为研究对象的特征描述。因此,我们对间充质基质细胞(MSC)试验参与者进行了调查,以了解他们的观点。我们发现,人们依赖于他们的胃肠病学家和结直肠外科医生来介绍试验,时间和费用是参与的主要障碍。总的来说,参与者对 MSC 试验参与表现出高度满意,但未来的方案可以增加使用虚拟预约来优化患者体验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d0a/11096429/84b289554b96/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d0a/11096429/1a13f3f284f3/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d0a/11096429/84b289554b96/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d0a/11096429/1a13f3f284f3/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d0a/11096429/84b289554b96/gr2.jpg

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本文引用的文献

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一项关于体外扩增的同种异体骨髓间充质干细胞治疗肛周瘘管型克罗恩病的IB/IIA期研究。
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