Liver Transplantation With Tregs at MGH
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Liver Transplant
In brief
This is a single-center, prospective, open-label, non-randomized clinical trial exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients.
Key facts
- Study ID
- NCT03577431
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 9
- Starts
- 2019-03-29
- Expected to finish
- 2027-04-06
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eligibility:
- Recipient:
- Individuals must meet all of the following criteria to be eligible for this study:
- Able to understand and provide informed consent
- End-stage liver disease and listed for a living or deceased-donor primary solitary liver transplant
- Agreement to use contraception
- Positive Epstein-Barr virus (EBV) antibody test and
- In the absence of contraindication, vaccinations must be up to date per the DAIT Guidance for Patients in Transplant Trials (Refer to the Manual of Procedures)
- Living Donor:
- Living donors must meet all of the following criteria to be eligible for this study:
- Able to understand and provide informed consent
- Meets site-specific clinical donor eligibility requirements
- Meets donor eligibility manufacturing requirements within 7 days prior to blood collection for manufacturing and
- Willingness to donate appropriate biologic samples.
- Deceased Donor:
- Deceased donors must meet the following criteria for their recipients to be eligible for this study:
- Meets site-specific clinical donor eligibility requirements and 2. Meets donor eligibility manufacturing requirements.
- Note:
- There are several stages to this study.
- Eligibility is evaluated at many time points during the study to assess whether a participant is safe to proceed to the next study stage.
You may not qualify if…
- Recipient:
- Individuals who meet any of the following criteria will not be eligible for this study:
- History of previous organ, tissue or cell transplant requiring or potentially requiring immunosuppression
- For cytomegalovirus (CMV) antibody negative recipients, a (CMV) antibody positive donor
- Known contraindication to cyclophosphamide or Mesna administration
- Serologic evidence of human immunodeficiency virus (HIV)-1/2 infection
- The need for chronic anti-coagulation that cannot be safely discontinued for a minimum of 1 week to safely perform a liver biopsy
- End stage liver disease secondary to autoimmune etiology (autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis) or other contraindications to drug withdrawal
- Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the investigator, may interfere with study compliance
- Past or current medical problems, treatments or findings that are not listed above, which, in the opinion of the investigator, may:
- - pose additional risks from participation in the study,
- interfere with the candidate's ability to comply with study requirements, or
- impact the quality or interpretation of the data obtained from the study.
- History of malignancy with a risk of recurrence judged by the investigator to be >1%, except for:
- - hepatocellular carcinoma,
- - completely treated in-situ cervical carcinoma, or
- - completely treated basal cell carcinoma.
- Chronic use of systemic glucocorticoids or other immunosuppressives, or biologic immunomodulators.
- Living Donor:
- Living donors who meet the following criteria will not be eligible for this study:
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- Any condition that, in the opinion of the investigator, may pose additional risks from participation in the study, may: -- interfere with the participant's ability to comply with study requirements or --impact the quality or interpretation of the data obtained from the study.
- Deceased Donor:
- Recipients of livers from deceased donors who meet the following criteria are ineligible for this study:
Where it is running
- Massachusetts General Hospital: Transplantation — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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