LITTMUS is comprised of two single-center, prospective, open-label, non-randomized clinical trials exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients. One of the trials will take place at Massachusetts General Hospital in Boston, MA and the other will take place at UCSF in San Fransico, CA.
The primary objective of the LITTMUS studies is to evaluate the safety and efficacy of a single IV dose of autologous, donor alloantigen-specific T regulatory cell (arTreg) product to induce operational tolerance following living or deceased donor liver transplantation.
LITTMUS will test a new approach to achieve transplant tolerance using the liver transplant recipient’s own T regulatory cells (Tregs) to produce donor alloantigen-specific Tregs. Donor alloantigen-specific Tregs are the primary investigational product in this study. Participants who successfully recieve arTregs and who successfully withdraw from immunosuppression will be closely followed for 2 years in order to monitor for any signs of transplant rejection.
About This Study
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 liver transplant recipients to take less or even stop anti-rejection medication without causing liver damage
Tregs are normally present in very low numbers and act as the brakes on the immune system. In this study, we will take cells from the recipient’s blood and cells from the living or deceased liver donor. Then we will use these cells in the laboratory to grow Tregs and find out if these Tregs can be used to protect the transplanted liver. These cells will be given to recipients only if both recipients and their living donors (if applicable) are doing well after transplant. After the study Tregs are administered, we will try to slowly reduce and possibly stop anti-rejection medications.
Liver transplant recipients who take part in this study and are able to stop all anti-rejection medications without harming their transplanted liver, will have achieved tolerance. We do not know whether 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 monitoring study participants very closely to catch any signs of rejection early so that we can treat it and keep participants and their livers healthy.
Do you Qualify for this Clinical Trial?
Eligible participants for the LITTMUS study will:
To learn more about this study and participant eligibility, please visit the study website: LittmusStudy.org.