Organoids in the Clinic: A Systematic Review of Outcomes

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 pre-clinical 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 clinical outcomes of organoid research has been published. The many promises of organoid research still need to be translated from bench to bed.

Entering, Linked with the Sphinx: Lysophosphatidic Acids Everywhere, All at Once, in the Oral System and Cancer

“…We need this option, as animals have differences from humans in both metabolism and immune function, and using them in disease models has confounding implications [114,131,139], which have impeded us from advancing as far as we have wished. The interested reader is referred to Hoffman et al (2022) [140] for a systematic review of clinical outcomes of organoid research, where they detail the clinical studies planned or already underway.…”

Making and Managing New Biological Entities: conceptual, ontological, epistemological, and ethical aspects

“…In organoid research, there are no clinically relevant outcomes reported from high-quality evidence after more than two decades of research (B. Hofmann et al 2022).…”