Ethical and regulatory issues of stem cell-derived 3-dimensional organoid and tissue therapy for personalised regenerative medicine

BMC Medicine

Research Article

Alexander R. Harris¹  Mary Jean Walker²  Frederic Gilbert³ 

[1] Department of Biomedical Engineering, University of Melbourne, 3010, Melbourne, Australia;Department of Politics, Media, and Philosophy, La Trobe University, 3086, Bundoora, Victoria, Australia;Ethics Lab, School of Humanities, University of Tasmania, Hobart, Tasmania, Australia;

关键词: Stem cell;    Regenerative medicine;    Ethics;    Clinical trials;    Preclinical testing;    Organoid;   

DOI  :  10.1186/s12916-022-02710-9

 received in 2022-06-17, accepted in 2022-12-14,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundRegenerative medicine has the potential to treat genetic disorders and replace damaged or missing tissue. The use of donor or animal tissue raises many well-known issues, including limited tissue availability, the possibility of rejection and patient infection. Stem cell therapy raised hope of overcoming these issues, but created new risks including tumour formation and limited benefit if the desired target tissue does not form. The recent development of 3-dimensional tissues, including organoids, allows the creation of more complex tissues for personalised regenerative medicine.MethodsThis article details the potential health risks of 3-dimensional organoid and tissue therapy versus dissociated stem cell therapy. The current ethical and regulatory issues surrounding 3-dimensional organoid and tissue therapy are presented with a focus on the highly influential FDA and International Society of Stem Cell Research (ISSCR) guidelines.ConclusionsThe potential use of 3-dimensional organoid and tissue therapy may deliver greater patient benefits than other regenerative medicine approaches, but raises new health and ethical risks. Preclinical testing of these therapies will not mitigate some of their risks; they may only be understood after first-in-human trials. The potential irreversibility and high risk of these therapies affects how clinical trials should be structured, including post-trial care for participants.

【 授权许可】

CC BY   
© The Author(s) 2022