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A clinical trial involving a promising gene therapy approach has come under scrutiny following the sudden death of its first pediatric participant. The trial, conducted by Capsida Biotherapeutics, aimed to address challenges in delivering gene therapies across the blood-brain barrier, a significant hurdle in treating neurological disorders.

一项涉及有前景的基因疗法的临床试验，在其首位儿科参与者突然死亡后受到了审查。这项由Capsida Biotherapeutics公司进行的试验，旨在解决将基因疗法递送到血脑屏障的挑战，这是治疗神经系统疾病的重大障碍。

The unexpected fatality has raised concerns within the scientific community and prompted further examination of the therapy’s safety..

意外的死亡事件引发了科学界的担忧，并促使人们进一步审视该疗法的安全性。

The patient, whose identity remains confidential, was part of an early-stage study designed to test the safety and efficacy of a novel delivery system for gene therapies targeting brain-related conditions. Researchers had been optimistic about overcoming long-standing obstacles associated with crossing the blood-brain barrier, which typically prevents many treatments from reaching affected areas of the brain.

患者的身份依然保密，他是参与一项早期研究的一部分，该研究旨在测试一种针对脑部相关疾病的新基因疗法递送系统的安全性和有效性。研究人员曾乐观地认为，可以克服与穿越血脑屏障相关的长期障碍，该屏障通常阻止许多治疗手段到达受影响的脑部区域。

The child’s death occurred shortly after receiving the treatment, though specific details regarding the cause remain unclear. Investigators are now working to determine whether the experimental therapy played a role in this outcome or if other factors were involved. This incident marks a significant moment for ongoing research into gene therapy applications and raises questions about balancing innovation with patient safety in clinical trials..

这名儿童在接种治疗后不久便死亡，但具体原因尚不清楚。调查人员正努力查明这种实验性疗法是否是导致这一结果的原因，还是有其他因素。这一事件标志着基因疗法应用的持续研究中的重要时刻，并引发了关于在临床试验中如何平衡创新与患者安全的问题。

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Source: GO-AI-ne1

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Date: December 15, 2025

日期：2025年12月15日

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