No Longer a Slogan - Now a Reality
Investment in Research
The long awaited announcement has come today from Quadram Institute Bioscience in Norwich Research Park  of the new investment in the new Microbiota Replacement Therapy (MRT) - also called Faecal Microbiota Transplant (FMT) - facility that is being set up for the UK clinical trial at the Quadram and which is being funded by Invest in ME Research .
Now the Biotechnology and Biological Sciences Research Council (BBSRC) has awarded a grant of £500,000 to build and equip a new facility at the Quadram Institute that meets Good Manufacturing Practice (GMP) standards.
The Medicines and Healthcare products Regulatory Agency (MHRA) classes MRT as a medicine which means it needs to be produced in a GMP-standard facility.
This new funding demonstrates and confirms not just the acknowledgement of the soundness of developing the Centre of Excellence for ME
in one of Europe's biggest and best-equipped research park.
It also will enable more awareness and attention to be given to ME, with more interest in researching the disease, more opportunities for new funding and greater removal of the stigma around ME in research and clinical circles that has been allowed to generated and perpetuated by some organisations and from the effects of false research in the past.
UK Clinical Trial
COVID has had an impact on being able to carry out any recommendations suggested by the MHRA in updating the facility (regarding building work) which is being set up specifically for this research into ME and for this clinical trial.
This new investment in the facilities enables the RESTORE-ME clinical trial to restart once the construction work and MRT facility have been completed and validated later this year.
The Trial Team have been working on preparing the Trial Documents (protocol, patient facing documentation, quality management documents etc) and Ethics/MHRA submission and are awaiting for further information from parties involved in order to progress the submission.
Invest - in ME Research
The name of the charity is Invest in ME Research. For a long time this was as much a statement, a call to action, as it was an identifier of a charity determined to bring forth change to the stale and establishment-biased environment that had been permitted to exist for so many years.
Yet, from the time that we began bringing in a nucleus of international researchers together in our conferences and later research colloquium – and when we initiated the proposal for a UK/European Centre of Excellence for ME – this has become more and more a fact and a strategy.
Following the funding of 5 PhDs, European research and clinical meetings and networks, eleven international research colloquia and what would have been fifteen public conferences had it not been for the pandemic, - and the only clinical trial for ME in the UK – one of the few in the world – we are in the phase where others are accepting the soundness of this strategy.
October 2022 Update
Invest in ME Research has been discussing for some months the desire to extend the scope of research at the centre and use the possibilities from the Restore_ME clinical trial to the fullest, in order to make the most of the investment and also to underline the importance and urgency of research into ME.
Developing a Centre of Excellence for ME requires new ideas as well as new and continued investment and increasing capability as well as capacity has been important for the development of the centre.
Now the Quadram Institute has received additional funding to extend the research from the FMT clinical trial.
This latest funded research (from a Solve ME/CFS Initiative Ramsay grant award ) concerns ' Immunosenescence, Premature Aging of the Immune System in ME and the Response to Fecal Microbe Transplantation ' and is looking at the relationship between microbial dysbiosis, symptoms and NK cell function in ME.
Chronic inflammation and declining immune function are consequences of ageing (immune senescence). The ageing of the immune system is a progressive decline in function and is known to be influenced by the GI (gastrointestinal) microbiome.
People with ME can have intestinal microbial dysbiosis and the gut may contribute to the chronic activation of the immune system by gaining access to the blood and immune cells because of a leaky gut wall.
Replenishing the gut with health promoting microbes can restore immune function in older people and could present a viable treatment option for treating the disease.
The Restore_ME clinical trial (a Phase IIb double-blind randomised controlled trial) will assess the efficacy of FMT in ME patients and allow further investigations in premature immune ageing and microbe dysbiosis.
The additional research will be carried out by Dr Katharine Seton, who has just completed her PhD funded by IiMER.
Katharine will be working with Assistant Professor Niharika Duggal from the Institute of Inflammation and Ageing at the University of Birmingham.
This new Investment in ME Research is a welcome acceptance of the value of developing the UK/European Centre of Excellence for ME in Norwich Research Park with the foundations and components all working together to allow a confident future strategy of funding to be made available to make this centre develop even further.
With existing European and international collaboration already in place then this is the way forward - and we are grateful that others are becoming aware of this potential.
In addition to the latest research, we hope to facilitate the creation of more collaboration with other institutes which, in turn, allows more awareness of ME to be spread around academia.
From the charity there will be more announcements coming.
The charity welcomes and is extremely grateful for the support from so many patients, carers, friends and other organisations who are supporting the Centre of Excellence for ME.
Invest in ME Research - Energising Research into ME
Additional News May 2023
May 2023 Update
Quadram has recently been awarded more funding for research at he center.
This research is based on theIiMER-funded projects already underway or coming to completion.
The recent award of £120k looks more at the gut virome and will include analysis in the cohort of patients involve in the IiMER-funded RESTORE-ME clinical trial.
This may assist in discovering biomarkers for ME.
This new investment validates the charity's strategy of developin a UK/European Centre of Excellence for ME which builds a strategy of biomedical research that complements existing and previous research and facilitates the collaboration across Europe that the charity has championed since 2007.
Professor Simon Carding discussed this in his presentation at the recent 15th Invest in ME Research International ME Conference 2023
Invest in ME Research - Energising/Mainstreaming Research into ME
References and Further Reading
- Work starts on new £500,000 facility in Norwich
- UK Charity Invest in ME Research grants funding for continued research into ME, including a clinical trial at the Quadram Institute.
- Rik Haagman's blog
- UK/European Centre of Excellence for ME Executive Summary
- Investment in ME Research 2023
- ` Input to UKCRC ME Research Working Group - Our View on a Different Approach