The biggest question is whether the treatment with removal of gluten-specific T cells will be sufficiently effective.

It is possible that if a few gluten-reactive T cells remain. These cells can expand on a new contact with gluten - and then the problem is back. It is also possible that there will be sensitisation of naive T cells that have not seen gluten before.

Basically, the initiation of coeliac disease from the beginning might again happen. This latter scenario we consider to be less of a problem though. 

Individuals with coeliac disease are not considered at higher risk of catching the flu or other viral or bacterial infectious diseases than non-coeliac individuals unless they have hyposplenism (a small spleen with reduced function). There is an increased risk of hyposlenism in people with coeliac disease compared with the general population, but risk is small.

Why hyposplenism develops in some people, we do not know. Coeliac disease in the absence of hyposplenism does not affect the overall immune system. In the disease process driven by gluten exposure, only a small fraction of all your immune cells get involved. While this immune response makes it very uncomfortable to eat gluten, it is unlikely to have an overall effect on the immune system unless the person has hyposplenisms. As it is unlikely to be tested for hyposplenism, people with coeliac disease are recommended to take certain vaccines.  

Actually the same enzyme is already on the market as Tolerase G in the US and with other trade names in Europe. It works during brewing of beer and also in human stomachs, but has not been tested properly as a treatment in coeliac disease. And it probably won’t work if for instance you drink milk with the enzyme.  

Probably, the ambition is this treatment will replace the gluten free diet (but this will be for the company to decide).

This trial was unsuccessful due to what is called a trial effect. All the participants in this trial whether they received the drug or placebo (the dummy drug) got better so it was impossible to conclude whether the drug was effective or not.

We do not expect that this should have any effect on the immune system in general as the gluten specific T cells are only a small population in the total T cell population. Therefore it should be completely safe to remove the gluten specific T cells if we can target them specifically. 

Addison’s disease also has an HLA association with the DR3-DQ2 and DR4-DQ8 haplotypes (some of the genes that predispose people to developing coeliac disease also predispose to Addison’s disease). Addison’s disease is a rare disorder so screening all people with coeliac disease for Addison’s disease would probably not be advised.

The short answer is no. The Sheffield group is doing very nice studies in the UK - very difficult to compete with them!

Yes, probably but not yet proven. It has not been well studied so far. Our centre is entering this field, but mainly on the B cell side.