Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2021
Autologous bone marrow-derived mesenchymal stromal cell therapy with early tacrolimus withdrawal: The randomized prospective, single-center, open-label TRITON study.
Trial report in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Effect of Hypothermic Machine Perfusion to Ameliorate Ischemia-Reperfusion Injury in Donor Organs.Frontiers in immunology · 2022Pooled it
- Peripheral Blood Immune Cell Composition After Autologous MSC Infusion in Kidney Transplantation Recipients.Transplant international : official journal of the European Society for Organ Transplantation · 2023Trial
- Autologous Mesenchymal Stem Cells for Treatment of Chronic Active Antibody-Mediated Kidney Graft Rejection: Report of the Phase I/II Clinical Trial Case Series.Transplant international : official journal of the European Society for Organ Transplantation · 2022Trial
- Cardiovascular Effects of Autologous Bone Marrow-Derived Mesenchymal Stromal Cell Therapy With Early Tacrolimus Withdrawal in Renal Transplant Recipients: An Analysis of the Randomized TRITON Study.Journal of the American Heart Association · 2021Trial
- Stem cell therapies to modulate harmful immune responses in kidney disease: progress toward clinical validation.Stem cells (Dayton, Ohio) · 2026Review
- Alemtuzumab Exposure and T Lymphocyte Depletion: A Population Pharmacokinetic-Pharmacodynamic Model of Alemtuzumab Induction Therapy for Kidney Transplantation.Clinical pharmacology and therapeutics · 2025Article
- Regulatory cell therapy for kidney transplantation and autoimmune kidney diseases.Pediatric nephrology (Berlin, Germany) · 2025Review
- Mesenchymal Stromal Cells for Aging Cartilage Regeneration: A Review.International journal of molecular sciences · 2024Review
- IDOTransplantation direct · 2024Article
- Factors associated with changes in echocardiographic parameters following kidney transplantation.Clinical research in cardiology : official journal of the German Cardiac Society · 2024Article
- Advances and potential of regenerative medicine in pediatric nephrology.Pediatric nephrology (Berlin, Germany) · 2024Review
- Mechanisms of Stem Cells and Their Secreted Exosomes in the Treatment of Autoimmune Diseases.Current stem cell research & therapy · 2024Review
- Immune modulation in transplant medicine: a comprehensive review of cell therapy applications and future directions.Frontiers in immunology · 2024Review
- Allogenic MSC infusion in kidney transplantation recipients promotes within 4 hours distinct B cell and T cell phenotypes.Frontiers in immunology · 2024Article
- Comparing the Benefits and Drawbacks of Stem Cell Therapy Based on the Cell Origin or Manipulation Process: Addressing Immunogenicity.Immune network · 2023Review
- Menstrual blood-derived endometrial stem cell, a unique and promising alternative in the stem cell-based therapy for chemotherapy-induced premature ovarian insufficiency.Stem cell research & therapy · 2023Review
- Cell-free DNA measurement of three genomes after allogeneic MSC therapy in kidney transplant recipients indicates early cell death of infused MSC.Frontiers in immunology · 2023Article
- Dosing Limitation for Intra-Renal Arterial Infusion of Mesenchymal Stromal Cells.International journal of molecular sciences · 2022Article
- Clinical and Molecular Profiling to Develop a Potential Prediction Model for the Response to Alemtuzumab Therapy for Acute Kidney Transplant Rejection.Clinical pharmacology and therapeutics · 2022Article
- Chimeric Antigen Receptor (CAR) Regulatory T-Cells in Solid Organ Transplantation.Frontiers in immunology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
After renal transplantation, there is a need for immunosuppressive regimens which effectively prevent allograft rejection, while preserving renal function and minimizing side effects. From this perspective, mesenchymal stromal cell (MSC) therapy is of interest. In this randomized prospective, single-center, open-label trial, we compared MSCs infused 6 and 7 weeks after renal transplantation and early tacrolimus withdrawal with a control tacrolimus group. Primary end point was quantitative evaluation of interstitial fibrosis in protocol biopsies at 4 and 24 weeks posttransplant. Secondary end points included acute rejection, graft loss, death, renal function, adverse events, and immunological responses. Seventy patients were randomly assigned of which 57 patients were included in the final analysis (29 MSC; 28 controls). Quantitative progression of fibrosis failed to show benefit in the MSC group and GFR remained stable in both groups. One acute rejection was documented (MSC group), while subclinical rejection in week 24 protocol biopsies occurred in seven patients (four MSC; three controls). In the MSC group, regulatory T cell numbers were significantly higher compared to controls (p = .014, week 24). In conclusion, early tacrolimus withdrawal with MSC therapy was safe and feasible without increased rejection and with preserved renal function. MSC therapy is a potentially useful approach after renal transplantation.
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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.