It is increasingly recognised models using human tissue or cells can contribute to a better understanding of human health and disease and drive the development of safe and efficacious medicinal products. These models can also help to reduce the reliance on animals in research and underpin more translationally relevant testing strategies.
What is human tissue?
Ex vivo tissue: Human tissue from surgery or post-mortem sources can be used in safety pharmacology studies, and both private and publically funded biobanking initiatives in the UK and EU are being developed to enable human tissue and metadata collection, storage and dissemination (e.g. CRC Tissue Directory and Coordination Centre in the UK and BBMRI-ERIC in the EU). Commercial biobanks are also supplying human tissue to pharmaceutical companies for use in these studies, and contract research organisations are offering out-sourced human tissue modeling.
Human stem cells: Recent advances in induced pluripotent stem cell (iPSC) technology and gene editing have expanded the definition of human tissue. The Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative is one example of a coordinated multinational approach to implementing iPSC-based models in safety assessment. iPSCs are often purchased from commercial suppliers, although non-commercial projects such as the European Bank for Induced Pluripotent Stem Cells (EBiSC) and Stem Cells for Biological Assays of Novel Drugs and Predictive Toxicology (STEMBANCC) are now providing alternative sources.
What is the NC3Rs Role?
Working closely with researchers from academia and industry, international regulatory agencies and other key stakeholders, we have embarked on a programme of work to explore, understand and address the barriers to increased human tissue use in research.
We have carried out surveys to map the human tissue modeling landscape, engaging the UK asthma research community and the global drug safety assessment community in order to better understand the extent of human tissue use and the potential barriers to wider adoption in these areas. The surveys identified similar key barriers, which include:
- Practicalities associated with acquisition and storage of human tissue.
- Access to a regular and sustainable supply of high-quality tissue with associated metadata;
- A confusing and complex regulatory landscape;