🏛️ Verified NIH Record • Updated 2026-05-05

Liver Transplantation With Tregs at MGH (NCT03577431)

A Phase I/II Drug Withdrawal Study of Alloantigen-Specific Tregs in Liver Transplantation (ITN073ST)

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

🩺 Plain-English Summary (8th-Grade Level)

This is a single-center, prospective, open-label, non-randomized clinical trial exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (16 items).

Location: Massachusetts General Hospital: Transplantation — Boston, Massachusetts

Age range: 18 Years to 70 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria: 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Massachusetts General Hospital: Transplantation — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗