Regulatory T Cell Therapy Study

I mentioned in my previous post that I had been asked to take part in a small study investigating how it may be possible to induce tolerance in liver transplant patients. I thought it might be interesting to share my experience of participating in this clinical trial.

It was explained to me that our immune system comprises cells called lymphocytes. There are different types of lymphocytes, and immunosuppression medication weakens all of them equally to prevent rejection.

Researchers have found that as well as making cells that damage the transplanted organ, our immune system also makes cells that suppress rejection. It is a particular type of lymphocyte called a ‘Regulatory T Cell’, that actually has a positive effect in inducing tolerance of the transplanted liver. I am told this has been shown to be effective in mice.

It is believed that these regulatory cells may be able to suppress rejection in liver transplant patients, and if so induce tolerance and allow patients to wean down their immunosuppression medication.

Clearly, for me, there is no guarantee of anything here because this is just a study, but if it is found to be effective the benefits for future transplant patients could be very significant.

The process involves detailed tests. I have already given over 20 tubes of blood, urine sample, and will have to undergo a liver biopsy to ensure there is no sub-clinical rejection before the trial process goes ahead. My Tacrolimus immunosuppression has been reduced and supplemented with Sirolimus.

Assuming the biopsy is fine (fingers crossed, as I really hate having them done), I will go through a process called leukapheresis. This involves lines being inserted and my blood being filtered through a machine to harvest a quantity of white blood cells, with the remaining blood being returned to my blood stream from the machine. I believe about four litres go through the machine.

From these white blood cells, the regulatory cells are isolated, purified, and expanded in a laboratory to increase the number by several orders of magnitude. At a later time these expanded cells will be re-introduced to my system using a regular infusion device.

A few days after the treatment, I will need to give blood samples six or seven times to analyse how well my immune system and the regulatory cells are working.

This study takes about a year to complete. Now I have typed all this out I really do feel like a guinea pig, or one of those poor laboratory mice.

It is early days, and I have to get past the biopsy next, but I will update with progress and let you know how this goes, if people are interested to hear.

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10 Replies

  • Sounds really interesting.

    I'm six months post transplant on 3mg adoport and mycophenolate 1000mg daily.

    Which centre iis conducting the trial and how were you recruited ?


  • So I was asked by my consultant at Kings if I would do this. I believe they are recruiting six people to this phase of the study.

  • Sounds very interesting and I look forward to reading more about this. I have had a number of discussions with my transplant team about lowering even more my immunosuppression doses (currently 2 x .5mg Tacrolimus + 1 x 500mg MF) but they have argued against it on the grounds that the benefits and the risks do not outweigh the potential benefits. I have to say that since transplant (5 years in December) I have had a couple of colds and the occasional bout of mouth ulcers so I have more or less given up on my campaign to reduce medications.

  • Hi Mike. Yes the study I am doing will not necessarily result in reducing my immunosuppression any further either. I now take 3mg of Advograf, and 1mg of Rapamune (sirolimus).

  • sounds interesting, i was on a trial regarding brain fogginess issues with Freeman Newcastle, (PBC related) it seems the world keeps on getting "cleverer" - your test group have some invasive "treatments" ....brave of you. Please do keep us all updated.

  • This sounds like a lot to go through and I admire your ability to be able to go through all of this in the hope that it will help others as well as possibly yourself. I hope it works out well for you and I would be very interested to hear how it all goes. Good luck :)

  • Well done Chris, really interesting too.

    Without folks like yourself who are willing to participate in these trials these amazing advances wouldn't happen so hopefully all goes smoothly with your various procedures and the docs make the leaps forward that they hope.

    All the best

    Katie x

  • I agree with AyrshireK

    Without willing volunteers ( guinea pigs ! ) there would be no progress.

    I know I would be prepared to take part for the sake of a bit of discomfort which nothing compared to the illness / transplant some of us have already endured.

    We should all be grateful to Chris and any others for taking part in such research.


  • Not sure if you guys are aware but the NHS has a web site where you can look for clinical trials that are open to volunteers. I believe the one I am doing is by selection only, but there are many others dealing with aspects of liver health that are open. The link is here.

  • We discussed this on another thread, but this is the continuation of a trial I was involved in almost a year ago. The difference I think being that my blood was taken before transplant, and reintroduced 3 months after.

    I've not noticed any side effects but my Tacrolimus has been completely stopped and I'm currently on 1mg / 2mg of Sirolimus on alternate days.

    I was the first patient on the trial. And it was quite a big event when the blood was reintroduced, there were a number of medical staff there, and the protocol taken was something like out of a sci-fi movie, when a finger size vile was removed from a 3ft square box by a surgeon with huge gloves to protect from the extreme cold, and ice vapour.

    I admit to secretly hoping this procedure might turn me into a super hero ;)

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