Willy, Christian and Bugert, Joachim J. and Classen, Annika Y. and Deng, Li and Duechting, Anja and Gross, Justus and Hammerl, Jens A. and Korf, Imke H. E. and Kuehn, Christian and Lieberknecht-Jouy, Simone and Rohde, Christine and Rupp, Markus and Vehreschild, Maria J. G. T. and Vogele, Kilian and Wienecke, Sarah and Witzenrath, Martin and Wuerstle, Silvia and Ziehr, Holger and Moelling, Karin and Broecker, Felix (2023) Phage Therapy in Germany-Update 2023. VIRUSES-BASEL, 15 (2): 588. ISSN , 1999-4915
Full text not available from this repository. (Request a copy)Abstract
Bacteriophage therapy holds promise in addressing the antibiotic-resistance crisis, globally and in Germany. Here, we provide an overview of the current situation (2023) of applied phage therapy and supporting research in Germany. The authors, an interdisciplinary group working on patient-focused bacteriophage research, addressed phage production, phage banks, susceptibility testing, clinical application, ongoing translational research, the regulatory situation, and the network structure in Germany. They identified critical shortcomings including the lack of clinical trials, a paucity of appropriate regulation and a shortage of phages for clinical use. Phage therapy is currently being applied to a limited number of patients as individual treatment trials. There is presently only one site in Germany for large-scale good-manufacturing-practice (GMP) phage production, and one clinic carrying out permission-free production of medicinal products. Several phage banks exist, but due to varying institutional policies, exchange among them is limited. The number of phage research projects has remarkably increased in recent years, some of which are part of structured networks. There is a demand for the expansion of production capacities with defined quality standards, a structured registry of all treated patients and clear therapeutic guidelines. Furthermore, the medical field is still poorly informed about phage therapy. The current status of non-approval, however, may also be regarded as advantageous, as insufficiently restricted use of phage therapy without adequate scientific evidence for effectiveness and safety must be prevented. In close coordination with the regulatory authorities, it seems sensible to first allow some centers to treat patients following the Belgian model. There is an urgent need for targeted networking and funding, particularly of translational research, to help advance the clinical application of phages.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | BACTERIOPHAGES; INFECTION; phage therapy; antimicrobial resistance; regulatory framework; Germany |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Unfallchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 30 Jan 2024 11:19 |
| Last Modified: | 30 Jan 2024 11:19 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60936 |
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