Residual blood from anonymous NBS platelet donors for use in assays-V1
Research type
Research Study
Full title
The use of anonymous blood leukocyte cones residual from platelet preparation by Southampton National Blood Service for assays to assess the activity of antibodies and other reagents, and to investigate and understand their mechanisms of action.
IRAS ID
186264
Contact name
Mark Cragg
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
18307, Southampton ERGO submission number
Duration of Study in the UK
4 years, 11 months, 22 days
Research summary
This work will use leukocyte cones obtained from the Southampton National Blood Service (NBS). These are residual after the processing of blood donated in order to obtain blood platelets for use in patients and would otherwise be discarded. The cones are never labelled with personal identifiers and a coding key is not generated. No donors are recruited specifically for this project, and no eligibility criteria other than those for NBS platelet donors are applied.
Cells derived from the cones will be used in a range of assays measuring cellular responses to investigate the activity of therapeutic and/or potentially therapeutic agents, the mechanisms underlying their activity, and how these may be manipulated. Our main interest is the therapeutic activity of monoclonal antibodies for the treatment of cancer, and how this may be improved. These in vitro assays are important for the pre-clinical development of such reagents.
Natural variations in the DNA sequence encoding specific proteins can lead to differences in their function or their interaction with other proteins and there is evidence that such variants may contribute to the pathogenesis, progression, and/or treatment outcome of diseases involving the immune system. One part of the study will be to use DNA sequencing to determine whether genetic changes can be correlated with activity in the in vitro assays.
The study will run for approximately 5 years and be funded by research grants from several fundingsources, including Cancer Research UK and Bloodwise, and also pharmaceutical companies including Bioinvent(Sweden)and Pfizer.REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0026
Date of REC Opinion
18 Jan 2016
REC opinion
Unfavourable Opinion