Organoids are 3D structure that mimic organs such as heart, liver, or retina. They can be derived from control or patient iPS cells to model genetic or other diseases and test therapeutics.

The US Federal Drug Administration (FDA) is now encouraging the use of cellular assays such as organoids for pre-clinical studies. CMRI’s Stem Cell & Organoid Facility welcomed the announcement by the FDA in December 2022 which stated that it is no longer a requirement of the FDA to have all drugs tested in rodent and non-rodent models prior to clinical trial approval.

This development allows robust studies using non-animal models, such as organoids, to proceed to clinical trials after FDA approval. Organoids are mini-organs grown in the dish using 3D differentiation systems and have been shown to be an important tool in precision and regenerative medicine, as well as drug discovery research.

CMRI’s Stem Cell and Organoid Facility offers a range of stem cell services, including an end-to-end workflow (iPSC reprogramming and maintenance, differentiation, organoid development and functional analysis) for a range of organoids including, but not limited to, cortical, whole cerebral, cardiac, and kidney organoids. Our goal is to create a widely available resource of human pluripotent stem cell-derived products and derivative tissues to provide functional disease models and accelerate our customers’ research.

Contact stemcor@cmri.org.au for more information on how we can create organoids for your basic or pre-clinical research.

Image: Inner ear organoid