a study on Liver Transplant
This research study is for liver transplant recipients and their respective living donors. The purpose of this study is: 1. To see if it is safe for liver recipients to receive one dose of donor reactive T regulatory cells (Tregs) 2. To see if the Tregs allows a liver recipient to take less, or completely stop medications normally taken after receiving an organ transplant.
Safety of Donor Alloantigen Reactive Tregs to Facilitate Minimization and/or Discontinuation of Immunosuppression in Adult Liver Transplant Recipients (CTOTC-12)
Doctors give drugs called immunosuppressants (IS) to people who receive a liver transplant. IS must be taken every day to prevent the body from injuring the transplanted liver by a process called rejection. Liver transplant recipients usually have to take these drugs for the rest of their lives. These drugs have harmful side effects. Researchers are looking for ways to keep a transplanted liver working normally with as little IS medications as possible. Finding a way to lower and then stop these medications will allow the liver recipient to avoid unwanted side effects.
Another area of research looks at how blood cells work to reject or accept an organ transplant. Studies show that some of the recipient's own cells, called T regulatory cells (Tregs), may play a part in accepting the transplanted liver and preventing rejection.
A recipient's Tregs can be grown in the laboratory to increase their number. Exposing the recipient's Tregs to the liver donor's cells will stimulate the Tregs that recognize the liver donor to grow vigorously. Giving these "donor reactive" Tregs back to the transplant recipient through a vein (intravenously) might allow a liver transplant recipient to take lower doses of IS, or perhaps to stop them altogether, without rejecting the liver.
The study team will collect information about the Treg infusion, liver tests and drug doses during IS withdrawal, and any problems that may arise in the study. Blood, liver tissue, and buccal (cheek) cells will be collected for research tests.
Liver Transplant Recipient Living Donor (of the Respective Liver Transplant Recipient) Regulatory T Cells ( Treg) Donor Alloantigen Reactive Tregs (darTregs) Liver Transplant Alloantigen Reactive Tregs Calcineurin Inhibitors (CNI) immunosuppressants (IS) Diphenhydramine Promethazine Acetaminophen Calcineurin Inhibitors
For people ages 18–70
Study Enrollment Inclusion Criteria:
Subjects who meet all of the following criteria are eligible for enrollment:
without cholangiocarcinoma morphology
Confirmatory CT or MRI of the abdomen and pelvis.
Study Enrollment Exclusion Criteria:
Participants who meet any of these criteria are not eligible for study enrollment:
darTregs Infusion Inclusion Criteria:
Subjects must meet all criteria below to receive darTregs infusion:
darTregs Infusion Exclusion Criteria:
Subjects who meet any of these criteria are not eligible for darTregs infusion:
Inclusion Criteria for Resuming IS Withdrawal after darTregs Infusion:
Subjects are eligible to resume IS withdrawal after darTregs infusion if all criteria below are met:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02474199.
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