LITTMUS is a clinical research study testing a new approach to achieve transplant tolerance using the liver transplant recipient’s own T regulatory cells (Tregs).
The goal of the LITTMUS study is to find out:
- Whether Tregs are safe to use after liver transplantation
- Whether Tregs can allow you to take less or even stop anti-rejection medication without damaging your liver
Tregs are normally present in your body in very low numbers and act as the brakes on your immune system. In this study, we will take cells from your blood and cells from your liver donor to use in the laboratory to grow Tregs and find out if these Tregs can be used to protect your transplanted liver. These cells will be given to you only if you and your liver are doing well after transplant. After you get the study Tregs, we will try to slowly reduce and possibly stop anti-rejection medications.
If you take part in this study and are able to stop your anti-rejection medications without harming your transplanted liver, you will have achieved tolerance. We do not know whether you or anyone participating in this study will achieve tolerance. It is reported that a small percentage of liver transplant recipients may become tolerant without undergoing any special medical treatment.
We think that being off anti-rejection medications might be good in the long run because of their known side effects. However, we don’t know if the potential benefits of being off these medications outweigh the risks. The main risk of not taking anti-rejection medications is rejection of the liver. We will be watching you and your liver very closely during the study to catch any sign of rejection early so that we can treat it and keep you and your liver healthy.