Evidence map›Paper›PMID 39731908›Full record

ArticleMed (New York, N.Y.)2025

Regulatory T cell therapy is associated with distinct immune regulatory lymphocytic infiltrates in kidney transplants.

Oliver McCallion, Amy R Cross, Matthew O Brook, Conor Hennessy, Ricardo Ferreira, Dominik Trzupek, William R Mulley, Sandeep Kumar, Maria Soares, Ian S Roberts and 6 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Med (New York, N.Y.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02129881 (The ONE Study), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
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.

NCT02129881 phase1 / phase2completednot on this map

The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation

TypeinterventionalSponsorGuy's and St Thomas' NHS Foundation TrustRan2014 to 2017Enrolled15ConditionsEnd-stage Renal FailureArmsAutologous regulatory T Cell Product
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. TIM3-mediated differentiation of IL-10-producing CD25Journal of molecular medicine (Berlin, Germany) · 2025
    Article
  10. Article
  11. Tolerance Induction Strategies in Organ Transplantation: Current Status and Future Perspectives.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Review
  12. Review
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

16 authors.

Oliver McCallionNuffield Department of Surgical Sciences, University of Oxford, Oxford OX3 9DU, UK.
Amy R CrossNuffield Department of Surgical Sciences, University of Oxford, Oxford OX3 9DU, UK.
Matthew O BrookDepartment of Renal Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford OX3 7LH, UK.
Conor HennessyNuffield Department of Surgical Sciences, University of Oxford, Oxford OX3 9DU, UK.
Ricardo FerreiraCentre for Human Genetics, Nuffield Department of Medicine, University of Oxford, Oxford OX3 7BN, UK.
Dominik TrzupekCentre for Human Genetics, Nuffield Department of Medicine, University of Oxford, Oxford OX3 7BN, UK.
William R MulleyDepartment of Nephrology, Monash Medical Centre & Department of Medicine, Monash University, Clayton, VIC 3168, Australia.
Sandeep KumarAdvanced Therapy Manufacturing (GMP) Unit, Guy's & St Thomas' NHS Foundation Trust and King's College London, London SE1 9RT, UK.
Maria SoaresDepartment of Cellular Pathology, Oxford University Hospitals NHS Foundation Trust, Oxford OX3 9DU, UK.
Ian S RobertsDepartment of Cellular Pathology, Oxford University Hospitals NHS Foundation Trust, Oxford OX3 9DU, UK.
Peter J FriendNuffield Department of Surgical Sciences, University of Oxford, Oxford OX3 9DU, UK.
Giovanna LombardiMRC Centre for Transplantation, King's College London, London SE1 9RT, UK.
Kathryn J WoodNuffield Department of Surgical Sciences, University of Oxford, Oxford OX3 9DU, UK.
Paul N HardenDepartment of Renal Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford OX3 7LH, UK.
Joanna HesterNuffield Department of Surgical Sciences, University of Oxford, Oxford OX3 9DU, UK.
Fadi IssaNuffield Department of Surgical Sciences, University of Oxford, Oxford OX3 9DU, UK. Electronic address: fadi.issa@nds.ox.ac.uk.

Funding

Medical Research Council MR/N027930/1Wellcome Trust 107212Wellcome Trust 211122
6 · The paper itself

Abstract

backgroundAdoptive transfer of autologous regulatory T cells (Tregs) is a promising therapeutic strategy aimed at enabling immunosuppression minimization following kidney transplantation. In our phase 1 clinical trial of Treg therapy in living donor renal transplantation, the ONE Study (ClinicalTrials.gov: NCT02129881), we observed focal lymphocytic infiltrates in protocol kidney transplant biopsies that are not regularly seen in biopsies of patients receiving standard immunosuppression.

methodsWe present 7 years of follow-up data on patients treated with adoptive Treg therapy early post-transplantation who exhibited focal lymphocytic infiltrates on a 9-month protocol biopsy. We phenotyped their adoptively transferred and peripherally circulating Treg compartments using CITE-seq and investigated the focal lymphocytic infiltrates with spatial proteomic and transcriptomic technologies.

findingsGraft survival rates were not significantly different between Treg-treated patients and the control reference group. None of the Treg-treated patients experienced clinical rejection episodes or developed de novo donor-specific antibodies, and three of ten successfully reduced their immunosuppression to tacrolimus monotherapy. All Treg-treated patients who underwent a protocol biopsy 9 months post-transplantation exhibited focal lymphocytic infiltrates. Spatial profiling analysis revealed prominent CD20

conclusionsWe demonstrate for the first time that immune cell infiltrates in transplanted kidneys can occur following adoptive Treg therapy in humans, potentially facilitating within-graft T:B cell interactions that promote local immune regulation.

fundingThis work was funded by the 7

Indexed as

Adoptive TransferGraft RejectionKidney TransplantationT-Lymphocytes, RegulatoryAdultBiopsyFemaleFollow-Up StudiesGraft SurvivalHumansImmunosuppressive AgentsMaleMiddle AgedImmunosuppressive Agentscellular therapyimmune infiltratesimmunosuppression minimizationkidney transplantationregulatory T cellsspatial profilingTranslation to patients

Identifiers

PMID39731908
PMCPMC7618234

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Registered trials

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.