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NC3Rs: National Centre for the Replacement Refinement & Reduction of Animals in Research
Guidance

Increasing human tissue use

It is increasingly recognised that 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?

A flow diagram showing the types of human tissue that can be sourced. The first box lists the three common sources of tissue: Post-mortem tissue, ex-vivo excised tissue and cells for reprogramming. This feeds into the centre box: Human Tissue for Research. 3 types of tissues or cells that come off from this box. Fresh tissues can be used for organotypic culture, multiple funcitonal readouts and microphysiological devices. Fixed tissues can be used for imaging and histochemistry, molecular pathology or recov

Ex vivo tissue: Human tissue from surgery or post-mortem sources, and human blood or fluids, can be used in research. Both private and publicly funded biobanking initiatives in the UK and EU are being developed to enable human tissue and metadata collection, storage and dissemination (e.g. UKCRC Tissue Directory and Coordination Centre in the UK and BBMRI-ERIC in the EU which are both publicly funded and can be used by researchers for free). 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 co-ordinated 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 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 modelling 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.

Improving access to human tissue

The most widely cited barrier preventing uptake of human tissue-based approaches is lack of access to a reliable source of tissue. However this is not considered a problem by all researchers and many consider that substantial amounts of human tissue are available in existing repositories and biobanks and from commercial sources; suggesting that a key issue is a lack of knowledge regarding what repositories exist.

There are a number of ongoing activities both in the UK and Europe to coordinate biobanking activity and provide researchers with a means to more easily identify and access collections of tissue relevant to them. The most coordinated of these is the UK Clinical Research Collaboration (UKCRC) Tissue Directory and Coordination Centre, which is the UK partner in the Biobanking and BioMolecular resources Research Infrastructure – European Research Infrastructure Consortium (BBMRI-ERIC). Another source of human tissue for research is the NHS Blood and Transplant service (NHS BT) which provides organs for transplant, but also supports scientists in accessing for research, organs which are not suitable for this purpose. Marketplaces for outsourced research services, such as Scientist.com, also offer opportunities for accessing tissue. 

If you have human tissue repositories accessible to researchers and would like to share these with the wider research community please let us know by contacting enquiries@nc3rs.org.uk

We have also funded projects to increase access to human tissue for specific applications:

  • A strategic collaboration between academics and NHS BT to develop a process to provide fully ethically consented, human normal and diseased lung tissue to the UK scientific community. If successful, the approach could apply to other organs and tissues.
     
  • A CRACK IT Challenge to put in place a system to supply high quality and viable dorsal root ganglion neurones to researchers to facilitate drug target identification and pharmacological testing of novel pain therapeutics.

Navigating the regulatory and ethical framework

Working with the Human Tissue Authority, we have developed a series of decision trees to help guide researchers through the regulatory framework for accessing and using human tissue to help overcome the often cited barrier that this is complex and confusing. The decision trees cover what is considered relevant material, licencing for storage of human tissue and whether consent is required for research.    

Other resources on this topic can be found on the MRC Regulatory Support Centre webpages.

Relevant Material: Determining if the human tissue you intend to use is considered relevant material (any tissue or sample containing human cells - some exclusions apply) and what licence you will need. 

Storing human tissue: Navigating the licensing requirements for storing human tissue for research.

Consent: Determining if consent is required to use human tissue for research.

Download the decision trees:

Human tissue for safety pharmacology

An NC3Rs/MHRA project to increase the use of human tissue models for safety assessment of new drugs.

You can view the full details on our project page: Human tissue for safety pharmacology.

Human tissue in asthma research

Asthma is a uniquely human disease, making it difficult to interpret data generated in animal models and apply the knowledge gained in a logical way to the human disease process.  Addressing this, we have a broad programme of work to develop alternative approaches to replace the use of animals and provide a better understanding of human asthma. This includes supporting the use of tissue engineering approaches, non-mammalian models (e.g. Drosophila, zebrafish), mathematical modelling and human tissue.

Barriers to human tissue use

Working with Asthma UK, the UK Respiratory Research Collaborative and the UK Human Tissue Authority we have surveyed the UK asthma research community to better understand the extent of human tissue use and the potential barriers to wider uptake.

The full survey data report and accompanying article in Thorax can be downloaded below, but it highlighted the potential impact greater use of human tissue could have on understanding the disease, but that access to reliable supplies of human tissue was not sufficient to meet demand. We have used the output from the survey to inform our activities in this area and provide resources and case studies to support researchers in their efforts to use human tissue as part of their asthma research programmes.

NC3Rs awards to increase access to human tissue

In 2016 we made an infrastructure award to Professor Maria Belvisi at Imperial College London to support the development of a process to provide fully ethically consented, post-mortem human normal and diseased lung tissue to the UK scientific community thereby reducing the need for animal tissue. The award is unique in that it includes a strategic partnership with NHS Blood and Transplant Tissue and Eye Services, the organisation responsible for coordinating, collecting, banking and providing tissue for transplant within the NHS. This partnership could truly transform access to human tissue for research purposes and although the initial focus is on asthma, the principles developed during this award will extend to other disease areas.

Working with members of our Asthma Advisory Group we provide below a series of case studies describing each of their different approaches to accessing human tissue to meet their research needs. These give a broad overview of the many ways human tissue can be sourced for research purposes and may guide you in your own efforts to adopt human tissue-based approaches.

Case studies