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. 2020 Sep 2;11:2155. doi: 10.3389/fimmu.2020.02155

TABLE 1.

Registered clinical trials involving regulatory T-cell therapy in liver transplantation.

Trial Institution Phase of the study Primary outcome Infused Treg clonality Number of patients enrolled Status
Todo/Okomura Hokkaido, Japan Phase I/IIA
  • –

    Safety

  • –

    IS weaning

  • –

    Number of Operationally Tolerant participants

 Donor specific 10 Data published (148)
ARTEMIS (NCT02474199) UCSF, United States Phase I/II
  • –

    Safety

  • –

    Incidence of AR, CR, re-transplantation, and death

  • –

    Patients Who Are Able to Reduce CNI Dosing and Discontinue a Second IS Drug with stable LFTs

 Donor specific 14 Completed
dELTA (NCT02188719) UCSF, United States Phase I
  • –

    Safety

 Donor specific 15 Terminated
LITTMUS-UCSF (NCT03654040) UCSF, United States Phase I/II
  • –

    Safety

  • –

    Number of Operationally Tolerant participants

 Donor specific N.A. Withdrawn
LITTMUS-MGH (NCT03577431) MGH, United States Phase I/II
  • –

    Safety

  • –

    Number of Operationally Tolerant participants

 Donor specific 9* Recruiting
ThRIL (NCT02166177) King’s college Hospital, United Kingdom Phase I/II
  • –

    Rate of dose limiting toxicities

  • –

    Graft Loss

 Polyclonal 9 Completed
NCT01624077 (First Trial) Nanjing, China Phase I
  • –

    Patient and graft survival

 Polyclonal 1* Unknown
NCT01624077 (Second Trial) Nanjing, China Phase I
  • –

    Patient and graft survival

 Donor specific 1* Unknown

From Clinicalgrials.gov, last accessed 19/05/2020. Abbreviations: IS, immunosuppression; AR, acute rejection; CR, chronic rejection; LFT, liver function tests. *Estimated.