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Review
. 2019 Oct;24(5):522-526.
doi: 10.1097/MOT.0000000000000678.

Regulatory barriers to xenotransplantation

Corbin E Goerlich  1   2 , Joshua L Chan  3 , Muhammad M Mohiuddin  1
Affiliations
Review

Regulatory barriers to xenotransplantation

Corbin E Goerlich et al. Curr Opin Organ Transplant. 2019 Oct.

Abstract

Purpose of review: There is a grave discordance between supply and demand for patients with failing organs largely due to an insufficient donor pool for transplantation. Xenotransplantation has been proposed as a solution to bridge this gap.

Recent findings: Recent success over the last decade in nonhuman primate models, due to emerging gene-editing technologies combined with novel immunosuppression regimens, has produced promising results in pancreatic islet cell, heart, lung, kidney and liver xenotransplantations.

Summary: As the prospect of xenotransplantation is realized, safety and ethical considerations have come to the forefront of discussion. The WHO and World Health Assembly have encouraged member states to form regulatory bodies to govern human xenotransplantation studies with the highest standards. Here, we summarize the current regulatory landscape governing preclinical advances toward the first human clinical trials.

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Conflict of interest statement

Conflicts of interest

There are no conflicts of interest.

References

    1. Carmona M 2016. Activity data report. GODT-Global Observatory on Donation and Transplantation.
    1. World Health Organization. WHO guidance on xenogeneic infection/disease surveillance and response: a strategy for international cooperation and coordination. 2001.
    1. [No authors listed]. First WHO global consultation on regulatory requirements for xenotransplantation clinical trials: Changsha, China, 19–21 November 2008. Xenotransplantation 2009; 16:61–63. - PubMed
    1. Hawthorne WJ, Cowan PJ, Bühler LH, et al. Third WHO global consultation on regulatory requirements for xenotransplantation clinical trials, Changsha, Hunan, China December 12–14, 2018: ‘The 2018 Changsha Communiqué’ the 10-year anniversary of the International Consultation on Xenotransplantation. Xenotransplantation 2019; 26:e12513. - PubMed

    2. The 3rd version of Changsha Communiqué, as detailed in this article, details updates in the xenotransplantation landscape as it stands today. It includes current preclinical progress, facilities for source pigs in xenotransplantation and the regulatory environment surrounding progress to the first clinical trials.

    1. Sykes M, d’ Apice A, Sandrin M; IXA Ethics Committee. Position paper of the Ethics Committee of the International Xenotransplantation Association. Xenotransplantation 2003; 10:194–203. - PubMed

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