The Future of Clinical Phage Therapy in the United Kingdom.
The Future of Clinical Phage Therapy in the United Kingdom.
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DOI：
10.3390/v15030721
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发表时间：
2023-03-10
期刊：
影响因子：
--
通讯作者：
Clark JR
中科院分区：
文献类型：
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作者：
Jones JD;Trippett C;Suleman M;Clokie MRJ;Clark JR
噬菌体（噬菌体）疗法是一种有前途的替代抗菌策略，有可能改变细菌感染的治疗方式。在英国，它被归类为生物医学。虽然没有许可在英国使用的抗生素，但在许可的替代品不能满足患者临床需求的情况下，它们可能被用作未经许可的药品。在过去的2年中，英国有12名患者接受了噬菌体治疗，并且临床兴趣正在蓬勃发展。目前，英国的临床噬菌体供应是临时性的，依赖于与国际来源的网络。在英国提供噬菌体治疗的进展将不会超过越来越多的特设案件，直到建立一个岸上的可持续和可扩展的来源，根据良好的生产规范（GMP）制造的良好特征的抗生素。在这里，我们介绍了英国噬菌体治疗、莱斯特大学噬菌体研究中心、CPI和固定噬菌体之间令人兴奋的新合作。这些合作伙伴以及我们正在开发的其他合作伙伴将在英国建立可持续，可扩展和公平的噬菌体治疗。我们为噬菌体疗法如何更广泛地整合到NHS和医疗保健中提出了一个愿景，包括许可（鸡尾酒）和未许可（个性化）噬菌体制剂之间的互补性。英国噬菌体治疗基础设施的关键要素将是GMP噬菌体制造，国家噬菌体库和国家临床噬菌体中心。这一基础设施将共同支持NHS微生物学部门在英国开发和监督噬菌体治疗。由于这需要时间来实现，我们还描述了寻求在过渡期间使用未经许可的噬菌体治疗的临床医生的考虑因素。总之，这篇综述为英国提供了一个临床噬菌体治疗的路线图，我们希望其益处将在未来几十年内对患者产生影响。
Bacteriophage (phage) therapy is a promising alternative antimicrobial strategy with the potential to transform the way bacterial infections are treated. In the United Kingdom, phages are classed as a biological medicine. Although no phages are licensed for UK use, they may be used as unlicensed medicinal products where licensed alternatives cannot meet a patient’s clinical needs. In the last 2 years, 12 patients in the UK have received phage therapy, and there is burgeoning clinical interest. Currently, clinical phage provision in the UK is ad hoc and relies upon networking with international sources of phages. The provision of phage therapy in the UK will not progress beyond an increasing number of ad hoc cases until an onshore sustainable and scalable source of well-characterised phages manufactured in accordance with Good Manufacturing Practice (GMP) is established. Here, we present an exciting new collaboration between UK Phage Therapy, the Centre for Phage Research at University of Leicester, CPI, and Fixed Phage. These partners, and others as we develop, will establish sustainable, scalable, and equitable phage therapy provision in the UK. We set out a vision for how phage therapy will be integrated into the NHS and healthcare more broadly, including the complementarity between licensed (cocktail) and unlicensed (personalised) phage preparations. Key elements of phage therapy infrastructure in the UK will be GMP phage manufacturing, a national phage library, and a national clinical phage centre. Together, this infrastructure will support NHS microbiology departments to develop and oversee phage therapy provision across the UK. As it will take time to deliver this, we also describe considerations for clinicians seeking to use unlicensed phage therapy in the interim. In summary, this review sets out a roadmap for the delivery of clinical phage therapy to the UK, the benefits of which we hope will reverberate for patients for decades to come.