Residual blood products from NHSBT platelet donation for use in assays
Research type
Research Study
Full title
The use of blood leucocyte cones residual from NHSBT platelet donation in laboratory assays for the research and development of therapeutic reagents
IRAS ID
186605
Contact name
Mark S Cragg
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
Southampton ERGO submission number, 19660
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
When blood is donated to the National Health Service Blood and Transplant (NHSBT) to provide samples for clinical use, leucocyte cones are produced as a by-product of the apheresis process and NHSBT make these available for purchase as non-clinical components for research as they would otherwise be discarded. Donors give generic consent for research use as part of the donation process, and are not identifiable. These leucocyte cones contain blood that is enriched with many different cell types found naturally in the blood and are useful in many assays employed in biological research and so are widely used by research institutions as an alternative to blood taken from laboratory volunteers. The research in the Antibody and Vaccine Group is focused primarily on the immunotherapy of cancer, and how this may be improved. The leucocyte cone derived cells are key components of laboratory assays used in the research effort to further understand this disease and in the development of drugs with the aim of providing improved therapeutic treatments. Typical readouts from such assays include cell proliferation, cytokine release, cell surface marker expression, expression of downstream signalling molecules or cytotoxicity. We also wish to determine if and how cellular responses to therapeutic reagents may be influenced by the expression of different forms of a protein due to natural variations in the DNA sequence between individuals, termed polymorphisms. Such information may help to explain why some donors respond in assays better than others, and inform the development of improved therapeutic reagents. This analysis will not involve genes of any diagnostic relevance, and the donors are healthy and anonymous and so our findings will not have any implications for their wellbeing or any subsequent treatments.
The study will run for approximately 5 years and be funded by peer-reviewed research grants from several funding sources, including Cancer Research UK and Bloodwise.Antibody therapy involves multiple cell types across the body and this cannot be adequately modelled in vitro with the technologies currently available and so there is no viable alternative to in vivo modelling using animals. To provide the most relevant in vivo models to investigate potential new therapeutics and/or the role of the immune system in cancer development and therapeutic responses, we may use human cells derived from NHS BT cones and/or commercial sources to transfer into mice. This will include the generation of ‘humanised’ mice, with fully human immune systems, which have become important pre-clinical tools for research, and involve the reconstitution of the immune system of immunocompromised mice by the injection of human cells. The protocol proposed will use commercially sourced foetal liver cells (from the USA); these are obtained with full ethical consent for their use.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
16/ES/0048
Date of REC Opinion
23 Mar 2016
REC opinion
Favourable Opinion