The development of a tissue bank, for blood samples and of a post mortem tissue archive will create, together with the Disease Register, a series of research infrastructure facilities which will transform the capability for research into ME/CFS in the UK. It means that researchers studying human tissue for evidence of underlying pathology, for example, will have access to detailed longitudinal clinical histories, through linkage to the disease register and the follow-up data it will contain

The Tissue Bank

The ME/CFS Bio-bank proposal involves the establishment of a facility to collect and store, for research purposes, in vivo tissue samples, mostly blood samples, from people with ME/CFS.

Such a facility would facilitate research leading to a better understanding of the causes and underlying pathological mechanisms of the illness. This in turn would lead to better recognition and legitimisation of the illness, identification of biomarkers, and the development of specific treatments.

A feasibility study has been carried out funded by Action for ME and the ME Association, which found general support for the concept among people with ME/CFS and scientific experts alike. Altruism was a major factor among people with ME/CFS, and experts saw a bio-bank as very cost-effective. Possible research questions to be investigated using the bio-bank could include RNA and DNA studies, particularly related to gene expressions, as well as viral studies including XMRV, and environmental factors and mitochondrial problems.

Issues to be addressed in the next stage of the project include:-

• precise identification of cases and controls, highlighting the importance of case definitions;

• standardised data collection methods, involving experienced people, in particular to ensure that severely affected people who have consented to take part are adequately represented in the bio-bank;

• rigorous protocols for transport and storage of samples;

• ethical and legal issues, including the need for informed consent and adequate assurances of anonymity and confidentiality to donors; 

• the importance of clinical data (which is why the link to the disease register is so important, as it will enable detailed information about the course of participants’ illnesses to be recorded and collated);

• attracting good quality research proposals to make optimum use of the facility;

• keeping donors, the research community and others informed about the progress of the project..

Further description on this topic may be found at http://www.hta.gov.uk/licensingandinspections/sectorspecificinformation/research.cfm

The Post Mortem Tissue Archive

A feasibility study, funded jointly by Action for ME and the ME Association, has been carried out to ascertain the feasibility of developing a national post-mortem ME/CFS tissue archive in the UK, to enhance studies on the causes and underlying mechanisms, including cell and tissue abnormalities associated with the condition. The study involved interviews with key informants, focus group discussions with people with ME/CFS, and a workshop with experts in ME/CFS or in tissue banking. The results of the study suggest that the establishment of the post-mortem ME/CFS tissue bank is both desirable and feasible, and would be acceptable to possible tissue donors, provided that some issues were explicitly addressed, including uses to which the archive might be put, family reactions, and cultural and religious issues.

You can read the published report (1) of the feasibility study at http://www.hta.gov.uk/licensingandinspections/sectorspecificinformation/research.cfm

An application for major research funding for the next stages of the proposal will shortly be made.

1) Lacerda EM, Nacul L, Pheby D, Shepherd C, Spencer P. Exploring the feasibility of establishing a disease-specific post-mortem tissue bank in the UK: a case study in ME/CFS. J Clin Pathol (2010); 63: 1032-1034.