Evidence map›Paper›PMID 31715056›Full record

ArticleAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2020

Applicability, safety, and biological activity of regulatory T cell therapy in liver transplantation.

Alberto Sánchez-Fueyo, Gavin Whitehouse, Nathali Grageda, Matthew E Cramp, Tiong Y Lim, Marco Romano, Sarah Thirkell, Katie Lowe, Laura Fry, Julie Heward and 16 more

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 137 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
137citing papers in PubMed, 1 pooled it
8.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

137 citing papers in PubMed, 1 synthesis or guideline pooled it, 199 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Nonclinical safety assessment of SBT777101, a CAR-engineered regulatory T cell therapy for autoimmune diseases.Toxicological sciences : an official journal of the Society of Toxicology · 2026
    Article
  4. Review
  5. Review
  6. Article
  7. Selective impact on regulatory T cells with sustained functional phenotypes by the interleukin-2 mutein VIS171 in a nonhuman primate model.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2026
    Article
  8. CD4Communications biology · 2026
    Article
  9. Article
  10. CAR-mediated release of IL-10 increases the function of regulatory T cells: Relevance for future clinical application.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Article
  11. Article
  12. Review
  13. CD25Frontiers in immunology · 2026
    Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Article

77 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 4 institutions in 2 countries.

Alberto Sánchez-FueyoInstitute of Liver Studies, MRC Centre for Transplantation, Department of Inflammation Biology, Faculty of Life Sciences & Medicine, King's College London, London, UK.ORCID 0000-0002-8316-3504
Gavin WhitehouseInstitute of Liver Studies, MRC Centre for Transplantation, Department of Inflammation Biology, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Nathali GragedaMRC Centre for Transplantation, Peter Gorer Department of Immunobiology, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Matthew E CrampHepatology Research Group, Plymouth University Peninsula Schools of Medicine and Dentistry, Southwest Liver Unit, Derriford Hospital, Plymouth Hospitals NHS Trust, Plymouth, UK.
Tiong Y LimInstitute of Liver Studies, MRC Centre for Transplantation, Department of Inflammation Biology, Faculty of Life Sciences & Medicine, King's College London, London, UK.ORCID 0000-0003-4814-5754
Marco RomanoMRC Centre for Transplantation, Peter Gorer Department of Immunobiology, Faculty of Life Sciences & Medicine, King's College London, London, UK.ORCID 0000-0001-6089-5828
Sarah ThirkellNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Katie LoweNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Laura FryNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Julie HewardNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Alex KerrNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Jakia AliNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Chris FisherNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Gillian LewisNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Andrew HopeNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Elisavet KodelaInstitute of Liver Studies, MRC Centre for Transplantation, Department of Inflammation Biology, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Mike LyneNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Farzin FarzanehSchool of Cancer and Pharmaceutical Sciences, King's College London, London, UK.
Shahram KordastiSystems Cancer Immunology Lab, Comprehensive Cancer Centre, King's College London, & Haematology Department Guy's Hospital, London, UK.
Irene Rebollo-MesaBiostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Juan Jose LozanoBioinformatic Platform, Biomedical Research Center in Hepatic and Digestive Diseases (CIBEREHD), Instituto de Salud Carlos III, Spain.
Niloufar SafiniaMRC Centre for Transplantation, Peter Gorer Department of Immunobiology, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Nigel HeatonInstitute of Liver Studies, MRC Centre for Transplantation, Department of Inflammation Biology, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Robert LechlerNIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
Marc Martínez-LlordellaInstitute of Liver Studies, MRC Centre for Transplantation, Department of Inflammation Biology, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Giovanna LombardiMRC Centre for Transplantation, Peter Gorer Department of Immunobiology, Faculty of Life Sciences & Medicine, King's College London, London, UK.
King's College London · GBDerriford Hospital · GBGuy's Hospital · GBInstituto de Salud Carlos III · ES

Funding

Biotechnology and Biological Sciences Research Council BB/D014301/1Biotechnology and Biological Sciences Research Council BB/E005896/1British Heart Foundation RG/13/12/30395Cancer Research UK 26813King's College LondonMedical Research Council G1002000Medical Research Council MC_PC_15108Medical Research Council MR/K025538/1Medical Research Council MR/P007694/1Medical Research Council Centre for Transplantation J006742/1National Institute for Health Research Biomedical Research CentreSt Thomas' National Health Service Foundation Trust
6 · The paper itself

Abstract

Regulatory T cells (Tregs) are a lymphocyte subset with intrinsic immunosuppressive properties that can be expanded in large numbers ex vivo and have been shown to prevent allograft rejection and promote tolerance in animal models. To investigate the safety, applicability, and biological activity of autologous Treg adoptive transfer in humans, we conducted an open-label, dose-escalation, Phase I clinical trial in liver transplantation. Patients were enrolled while awaiting liver transplantation or 6-12 months posttransplant. Circulating Tregs were isolated from blood or leukapheresis, expanded under good manufacturing practices (GMP) conditions, and administered intravenously at either 0.5-1 million Tregs/kg or 3-4.5 million Tregs/kg. The primary endpoint was the rate of dose- limiting toxicities occurring within 4 weeks of infusion. The applicability of the clinical protocol was poor unless patient recruitment was deferred until 6-12 months posttransplant. Thus, only 3 of the 17 patients who consented while awaiting liver transplantation were dosed. In contrast, all six patients who consented 6-12 months posttransplant received the cell infusion. Treg transfer was safe, transiently increased the pool of circulating Tregs and reduced anti-donor T cell responses. Our study opens the door to employing Treg immunotherapy to facilitate the reduction or complete discontinuation of immunosuppression following liver transplantation.

Indexed as

Liver TransplantationT-Lymphocytes, RegulatoryAdoptive TransferAnimalsHumansImmunosuppression TherapyTissue Donorscellular transplantation (nonislet)immunosuppression/immune modulationliver transplantation/hepatologyT cell biologytolerancetranslational research/science

Identifiers

PMID31715056
PMCPMC7154724
OpenAlexW2983615744

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.