DCreg in Living Donor Liver Transplantation

Summary

Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients will receive a single infusion of donor-derived DCreg 1 week prior to transplantation. All patients will be maintained on MPA and Tacrolimus (Tac) for the 1st 6 months after transplantation. At that time point, recipients meeting specific criteria will be slowly weaned off MPA per standard of care over a period of 6 months. Participants will then be evaluated for TAC weaning at 1 yr after transplantation. Those who meet specific criteria be weaned off Tac over 6 months . Successfully weaned participants who remain rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression.

Timeline

Start

2017-08-30

Primary completion

2024-07-15

Completion

2024-07-15

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Given the exploratory nature of this trial, additional studies to evaluate efficacy are needed. PMID 41997912 ↗

Publications

• Humar A, Hadjiyannis Y, Macedo C, Tran LM, Elinoff BD, Hughes CB, Ganesh SR, Zahorchak AF, Ables EM, Styn MA, Landsittel D, Zeevi A, Lakkis FG, Metes DM, Thomson AW. Donor-derived regulatory dendritic cell infusion and early immunosuppressive drug withdrawal in living-donor liver transplantation: a phase I/IIa trial. Nat Commun. 2026 Apr 17;17(1):3226. doi: 10.1038/s41467-026-71280-8.

Drugs

Indications

No indication recorded.