Application Note: Human Endometrial Organoids as a New Approach Methodology (NAM) for Preclinical Cytotoxicity Testing in Women’s Reproductive Health

Authors: Amber L. Cramer, Morgan M. Stanton*
Opal Therapeutics, 135 Mississippi St., San Francisco, CA 94107

Introduction

Progress in women’s reproductive health has long been hindered by the absence of reliable in vitro and ex vivo models for therapeutic testing and basic research. Like many fields, reproductive health has historically relied on rodent models to advance therapeutic candidates into clinical trials. However, this strategy has significant limitations: rodents do not menstruate, and the genetic similarity between rodent and human uterine receptive tissue is estimated to be less than 5% [1]. As a result, up to 30% of drug recalls are due to adverse female-specific effects that were not captured in preclinical studies [2] . It’s estimated that if toxicity studies were more accurate in pre-clinical studies, success rates of clinical trials would increase from 12% overall to 56% [3] .

In parallel, there is growing momentum from regulatory agencies to adopt non-animal alternatives for preclinical testing. In the past year, both the National Institutes of Health (NIH) and U.S. Food and Drug Administration (FDA) have emphasized the use of New Approach Methodologies (NAMs)…

See link below for full Opal Therapeutics Application Note