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Updated: Aug 27, 2025

A High-Throughput Platform for Culture and 3D Imaging of Organoids
Published on: October 14, 2022
Organoids in the Clinic: A Systematic Review of Outcomes
Bjørn Hofmann1,2, Severin Zinöcker1,3, Søren Holm1,4
1Centre for Medical Ethics, University of Oslo, Oslo, Norway.
Abstract:
Research on organoids has undergone significant advances during the last decade. However, outcomes from the use of organoids in clinical trials have not yet been documented. Therefore, there is an urgent need to assess the reporting of clinically relevant outcomes from organoid research in the scientific literature. This article presents a systematic review and appraisal of the published literature in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, together with a synopsis of recent relevant reviews. Surprisingly, no randomized controlled trials have reported clinical outcomes with any types of organoids. We found very few ongoing and registered studies that may provide clinically relevant results within this decade. Our screening and interpretation of the literature, including review articles, indicate a focus on technical and preclinical aspects of organoid research. This is the first systematic review of clinical trials involving organoids. Few clinical studies are planned or already underway, and, so far, no high-quality evidence relating to the clinical outcomes of organoid research has been published. The many promises of organoid research still need to be translated from bench to bed.
Insights
Organoid research shows promise, but clinical trial outcomes are undocumented. This systematic review found no randomized controlled trials reporting clinical results, highlighting a gap in translating organoid technology from lab to patient care.
Area of Science:
- Regenerative Medicine
- Translational Research
- Biomedical Engineering
Background:
- Organoid research has advanced significantly over the last decade.
- Clinical trial outcomes from organoid use remain largely undocumented.
- There is a critical need to evaluate the reporting of clinically relevant outcomes in organoid research literature.
Conclusions:
- This is the first systematic review specifically examining clinical trials involving organoids.
- There is a scarcity of clinical studies planned or underway, and no high-quality evidence on clinical outcomes has been published to date.
- The translation of organoid research promises from the laboratory ('bench') to patient care ('bed') is still in its early stages.

