ArticleBMJ open2022
Transplantation Without Overimmunosuppression (TWO) study protocol: a phase 2b randomised controlled single-centre trial of regulatory T cell therapy to facilitate immunosuppression reduction in living donor kidney transplant recipients.
Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.
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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.
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Who cites it
32 citing papers in PubMed, 48 citations in OpenAlex.
- Tacrolimus-resistant regulatory T cells: Combining the best of both worlds?Molecular therapy. Advances · 2026Article
- Phase I trial of autologous regulatory T cells for immune aplastic anemia.Haematologica · 2026Article
- Programmed death-ligand 1 on ex vivo-expanded toll-like-receptor-Bregs prevents allograft rejection by Breg viability promotion, CD4American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2026Article
- Article
- Vascularised Composite Allotransplantation: Emerging Applications in Reconstructive Surgery and Solid Organ Transplantation.Medicina (Kaunas, Lithuania) · 2026Review
- Engineering human Tregs to resist tacrolimus via FKBP12 gene editing.Frontiers in immunology · 2026Article
- Regulatory T cell therapies: biological foundations, engineering strategies, and clinical translation.Frontiers in immunology · 2026Review
- TIM3-mediated differentiation of IL-10-producing CD25Journal of molecular medicine (Berlin, Germany) · 2025Article
- Cellular Therapies in Transplantation - Regulatory T Cell Therapies and Virus Specific Therapies.Current transplantation reports · 2025Article
- HLA matching or CRISPR editing of HLA class I/II enables engraftment and effective function of allogeneic human regulatory T cell therapy in a humanized mouse transplantation model.Nature communications · 2025Article
- Regulatory T cell therapy in solid organ transplantation: clinical applications and laboratory monitoring strategies.Clinical transplantation and research · 2025Review
- Regulatory T cell therapy in autoimmune liver disease and transplantation.JHEP reports : innovation in hepatology · 2025Review
- Cytokines in transplantation tolerance.Best practice & research. Clinical haematology · 2025Review
- Regulatory T cell therapy is associated with distinct immune regulatory lymphocytic infiltrates in kidney transplants.Med (New York, N.Y.) · 2025Article
- Tolerogenic Therapies in Cardiac Transplantation.International journal of molecular sciences · 2025Review
- The future of nephrology in 2050.Future healthcare journal · 2025Article
- Evaluating Activated Regulatory T Cells as a Biomarker of Chronic Allograft Inflammation in Pediatric Kidney Transplant Recipients.Pediatric transplantation · 2025Article
- Harnessing the biology of regulatory T cells to treat disease.Nature reviews. Drug discovery · 2025Review
- Tolerance Induction Strategies in Organ Transplantation: Current Status and Future Perspectives.Transplant international : official journal of the European Society for Organ Transplantation · 2025Review
- Regulatory cell therapy for kidney transplantation and autoimmune kidney diseases.Pediatric nephrology (Berlin, Germany) · 2025Review
Corrections and comments
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Authors and funding
14 authors at 4 institutions in 1 country.
Funding
Abstract
introductionRegulatory T cell (Treg) therapy has been demonstrated to facilitate long-term allograft survival in preclinical models of transplantation and may permit reduction of immunosuppression and its associated complications in the clinical setting. Phase 1 clinical trials have shown Treg therapy to be safe and feasible in clinical practice. Here we describe a protocol for the TWO study, a phase 2b randomised control trial of Treg therapy in living donor kidney transplant recipients that will confirm safety and explore efficacy of this novel treatment strategy. METHODS AND ANALYSIS: 60 patients will be randomised on a 1:1 basis to Treg therapy (TR001) or standard clinical care (control). Patients in the TR001 arm will receive an infusion of autologous polyclonal ex vivo expanded Tregs 5 days after transplantation instead of standard monoclonal antibody induction. Maintenance immunosuppression will be reduced over the course of the post-transplant period to low-dose tacrolimus monotherapy. Control participants will receive a standard basiliximab-based immunosuppression regimen with long-term tacrolimus and mycophenolate mofetil immunosuppression. The primary endpoint is biopsy proven acute rejection over 18 months; secondary endpoints include immunosuppression burden, chronic graft dysfunction and drug-related complications. ETHICS AND DISSEMINATION: Ethical approval has been provided by the National Health Service Health Research Authority South Central-Oxford A Research Ethics Committee (reference 18/SC/0054). The study also received authorisation from the UK Medicines and Healthcare products Regulatory Agency and is being run in accordance with the principles of Good Clinical Practice, in collaboration with the registered trials unit Oxford Clinical Trials Research Unit. Results from the TWO study will be published in peer-reviewed scientific/medical journals and presented at scientific/clinical symposia and congresses. TRIAL REGISTRATION NUMBER: ISRCTN: 11038572; Pre-results.
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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.