From evidence to practice: factors influencing the implementation of cord blood treatment for cerebral palsy in the United States.

IF 5.9 2区 医学 Q1 CELL & TISSUE ENGINEERING
Madison C B Paton, Joanne Kurtzberg, Jessica Sun, Sarah Reedman, Remy Blatch-Williams, Michael Fahey, Iona Novak, Megan Finch-Edmondson
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Abstract

Background and aims: Cord blood infusion is an emerging treatment for cerebral palsy (CP) currently offered in the United States through clinical trials and an expanded access pathway. This study aimed to understand the barriers and facilitators influencing implementation of cord blood treatment for CP, to help inform future implementation efforts.

Methods: Semi-structured interviews were conducted with US professionals involved in the cord blood treatment program for CP at Duke University and a collaborator site. Data were analyzed using reflexive thematic analysis.

Results: From 16 interviews, 5 themes were identified capturing patterned barriers and enablers. Key facilitators included boundary-spanning clinical leadership, interprofessional coordination, dedicated resourcing, responsiveness to community demand, an established safety profile, and a strong research culture. Barriers included the need for cross-disciplinary expertise, uncertainty regarding efficacy evidence, funding and regulatory constraints, and system-level challenges. Participants described that many barriers were overcome to establish the program, while acknowledging that others may persist and are context dependent.

Conclusions: Findings highlight that implementation of cord blood treatment for CP is feasible within specialized settings but contingent on local infrastructure, governance, and workforce capacity. Identified facilitators align with established implementation strategies and offer transferable insights, while underscoring the need for regulatory approval, ethical oversight, and system-level supports to enable equitable and sustainable access to emerging regenerative therapies for CP.

从证据到实践:影响美国脑瘫患者脐带血治疗实施的因素。
背景和目的:脐带血输注是脑瘫(CP)的一种新兴治疗方法,目前在美国通过临床试验和扩大准入途径提供。本研究旨在了解影响脐带血治疗CP实施的障碍和促进因素,以帮助为未来的实施工作提供信息。方法:对参与杜克大学脐带血治疗CP项目的美国专业人员和合作站点进行半结构化访谈。数据分析采用反身性主题分析。结果:从16个访谈中,确定了5个主题,捕捉模式障碍和推动因素。关键的促进因素包括跨界临床领导、跨专业协调、专用资源、对社区需求的响应、已建立的安全概况和强大的研究文化。障碍包括对跨学科专业知识的需求、有效性证据的不确定性、资金和监管限制以及系统层面的挑战。参与者描述说,他们克服了许多障碍,建立了这个项目,同时承认其他障碍可能会持续存在,并且依赖于具体情况。结论:研究结果强调,在专业环境中实施脐带血治疗CP是可行的,但取决于当地的基础设施、治理和劳动力能力。确定的促进者与既定的实施战略保持一致,并提供可转移的见解,同时强调监管批准、道德监督和系统级支持的必要性,以确保公平和可持续地获得新兴的再生治疗CP。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Stem Cells Translational Medicine
Stem Cells Translational Medicine CELL & TISSUE ENGINEERING-
CiteScore
12.90
自引率
3.30%
发文量
140
审稿时长
6-12 weeks
期刊介绍: STEM CELLS Translational Medicine is a monthly, peer-reviewed, largely online, open access journal. STEM CELLS Translational Medicine works to advance the utilization of cells for clinical therapy. By bridging stem cell molecular and biological research and helping speed translations of emerging lab discoveries into clinical trials, STEM CELLS Translational Medicine will help move applications of these critical investigations closer to accepted best patient practices and ultimately improve outcomes. The journal encourages original research articles and concise reviews describing laboratory investigations of stem cells, including their characterization and manipulation, and the translation of their clinical aspects of from the bench to patient care. STEM CELLS Translational Medicine covers all aspects of translational cell studies, including bench research, first-in-human case studies, and relevant clinical trials.
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