Ethical and regulatory issues of stem cell-derived 3-dimensional organoid and tissue therapy for personalised regenerative medicine
Abstract Background Regenerative 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...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-12-01
|
| Series: | BMC Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12916-022-02710-9 |
| _version_ | 1828083339408441344 |
|---|---|
| author | Alexander R. Harris Mary Jean Walker Frederic Gilbert |
| author_facet | Alexander R. Harris Mary Jean Walker Frederic Gilbert |
| author_sort | Alexander R. Harris |
| collection | DOAJ |
| description | Abstract Background Regenerative 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. Methods This 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. Conclusions The 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. |
| first_indexed | 2024-04-11T04:06:17Z |
| format | Article |
| id | doaj.art-6f19dbee32dd4a5199577e76f753c983 |
| institution | Directory Open Access Journal |
| issn | 1741-7015 |
| language | English |
| last_indexed | 2024-04-11T04:06:17Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj.art-6f19dbee32dd4a5199577e76f753c9832023-01-01T12:21:12ZengBMCBMC Medicine1741-70152022-12-0120111110.1186/s12916-022-02710-9Ethical and regulatory issues of stem cell-derived 3-dimensional organoid and tissue therapy for personalised regenerative medicineAlexander R. Harris0Mary Jean Walker1Frederic Gilbert2Department of Biomedical Engineering, University of MelbourneDepartment of Politics, Media, and Philosophy, La Trobe UniversityEthics Lab, School of Humanities, University of TasmaniaAbstract Background Regenerative 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. Methods This 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. Conclusions The 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.https://doi.org/10.1186/s12916-022-02710-9Stem cellRegenerative medicineEthicsClinical trialsPreclinical testingOrganoid |
| spellingShingle | Alexander R. Harris Mary Jean Walker Frederic Gilbert Ethical and regulatory issues of stem cell-derived 3-dimensional organoid and tissue therapy for personalised regenerative medicine BMC Medicine Stem cell Regenerative medicine Ethics Clinical trials Preclinical testing Organoid |
| title | Ethical and regulatory issues of stem cell-derived 3-dimensional organoid and tissue therapy for personalised regenerative medicine |
| title_full | Ethical and regulatory issues of stem cell-derived 3-dimensional organoid and tissue therapy for personalised regenerative medicine |
| title_fullStr | Ethical and regulatory issues of stem cell-derived 3-dimensional organoid and tissue therapy for personalised regenerative medicine |
| title_full_unstemmed | Ethical and regulatory issues of stem cell-derived 3-dimensional organoid and tissue therapy for personalised regenerative medicine |
| title_short | Ethical and regulatory issues of stem cell-derived 3-dimensional organoid and tissue therapy for personalised regenerative medicine |
| title_sort | ethical and regulatory issues of stem cell derived 3 dimensional organoid and tissue therapy for personalised regenerative medicine |
| topic | Stem cell Regenerative medicine Ethics Clinical trials Preclinical testing Organoid |
| url | https://doi.org/10.1186/s12916-022-02710-9 |
| work_keys_str_mv | AT alexanderrharris ethicalandregulatoryissuesofstemcellderived3dimensionalorganoidandtissuetherapyforpersonalisedregenerativemedicine AT maryjeanwalker ethicalandregulatoryissuesofstemcellderived3dimensionalorganoidandtissuetherapyforpersonalisedregenerativemedicine AT fredericgilbert ethicalandregulatoryissuesofstemcellderived3dimensionalorganoidandtissuetherapyforpersonalisedregenerativemedicine |