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Argument for allowing first-in-human cardiac xenotransplantation clinical trials in paediatric patients
  1. Daniel J Hurst1,
  2. Anthony Merlocco2,
  3. Luz A Padilla3,
  4. Chris Bobier4
  1. 1Family Medicine, Rowan University School of Osteopathic Medicine, Stratford, New Jersey, USA
  2. 2Pediatric Cardiology, The University of Tennessee Health Science Center, Memphis, Tennessee, USA
  3. 3Epidemiology and Surgery, The University of Alabama at Birmingham, Birmingham, Alabama, USA
  4. 4Central Michigan University College of Medicine, Mount Pleasant, Michigan, USA
  1. Correspondence to Dr Daniel J Hurst; hurst{at}rowan.edu

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We read with interest the recent article on criteria for patient selection of cardiac xenotransplantation by Kögel et al.1 The authors recognise the benefits and concerns of first developing xenotransplantation trials in children (or at least concurrent development). They conclude that, based on (1) the vulnerable nature of children and (2) the observation that ‘the benefits of cardiac xenotransplantation have never been systematically proven in humans,’ that the ‘very first clinical trials should be conducted with adult patients.’ This is a long-standing contention in xenotransplantation that, to our knowledge, finds its origins in the Nuffield Council on Bioethics’ 1996 report on xenotransplantation, which states: ‘It would be difficult to justify the involvement of children in major and risky xenotransplantation trials before some of the uncertainties have been eliminated in trials involving adults.’2 However, given the cardiac allotransplant waitlist mortality borne by some paediatric patients, as well as other factors that raise unique candidacy considerations in children compared with adults—and arguably make some children better candidates than adults—we do not believe …

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Footnotes

  • X @hurstdanielj

  • Contributors DJH, the guarantor, drafted the first proposal and the remaining authors contributed to specific portions and the overall content.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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