Evidence map›Paper›PMID 37483623›Full record

ArticleFrontiers in immunology2023

Five-year follow-up of a phase I trial of donor-derived modified immune cell infusion in kidney transplantation.

Matthias Schaier, Christian Morath, Lei Wang, Christian Kleist, Gerhard Opelz, Thuong Hien Tran, Sabine Scherer, Lien Pham, Naruemol Ekpoom, Caner Süsal and 31 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Frontiers in immunology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02560220 (A Single-arm Phase-I Trial for the Determination of Safety and Feasibility of the Intravenous Administration of Mitomycin C-treated Donor Peripheral Blood Mononuclear Cells), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.8field-weighted citation impact, top 16% 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.

NCT02560220 phase1completednot on this map

A Single-arm Phase-I Trial for the Determination of Safety and Feasibility of the Intravenous Administration of Mitomycin C-treated Donor Peripheral Blood Mononuclear Cells (MICs) for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients (TOL-1 Study)

TypeinterventionalSponsorHeidelberg UniversityRan2015 to 2017Enrolled14ConditionsKidney Failure, ChronicArmsMitomycin C-induced peripheral blood mononuclear cells (MICs)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

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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

41 authors at 11 institutions in 6 countries.

Matthias SchaierDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Christian MorathDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Lei WangTolerogenixX GmbH, Heidelberg, ;Germany.
Christian KleistInstitute of Immunology, Heidelberg University Hospital, Heidelberg, ;Germany.
Gerhard OpelzInstitute of Immunology, Heidelberg University Hospital, Heidelberg, ;Germany.
Thuong Hien TranInstitute of Immunology, Heidelberg University Hospital, Heidelberg, ;Germany.
Sabine SchererInstitute of Immunology, Heidelberg University Hospital, Heidelberg, ;Germany.
Lien PhamInstitute of Immunology, Heidelberg University Hospital, Heidelberg, ;Germany.
Naruemol EkpoomInstitute of Immunology, Heidelberg University Hospital, Heidelberg, ;Germany.
Caner SüsalInstitute of Immunology, Heidelberg University Hospital, Heidelberg, ;Germany.
Gerald PonathDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Florian KälbleDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Claudius SpeerDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Louise BenningDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Christian NusshagDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Christoph F MahlerDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Luiza Pego da SilvaDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Claudia SommererDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Angela Hückelhoven-KraussDepartment of Hematology, Oncology and Rheumatology, Heidelberg University Hospital, Heidelberg, ;Germany.
David CzockDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, ;Germany.
Arianeb MehrabiDepartment of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, ;Germany.
Constantin SchwabInstitute of Pathology, Heidelberg University Hospital, Heidelberg, ;Germany.
Rüdiger WaldherrInstitute of Pathology, Heidelberg University Hospital, Heidelberg, ;Germany.
Paul SchnitzlerCenter for Infectious Diseases, Virology, Heidelberg University Hospital, Heidelberg, ;Germany.
Uta MerleDepartment of Gastroenterology, Heidelberg University Hospital, Heidelberg, ;Germany.
Vedat SchwengerDepartment of Nephrology, Klinikum der Landeshauptstadt Stuttgart, Stuttgart, ;Germany.
Markus KrautterDepartment of Nephrology, Klinikum der Landeshauptstadt Stuttgart, Stuttgart, ;Germany.
Stephan KemmnerTransplant Center, University Hospital Munich, Ludwig-Maximilians University (LMU), Munich, ;Germany.
Michael FischerederDivision of Nephrology, Department of Internal Medicine IV, University Hospital Munich, Ludwig-Maximilians-Universität München (LMU), Munich, ;Germany.
Manfred StanglDepartment of General, Visceral, and Transplant Surgery, University Hospital Munich, Ludwig-Maximilians-Universität München (LMU), Munich, ;Germany.
Ingeborg A HauserMedical Clinic III, Department of Nephrology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, ;Germany.
Anna-Isabelle KälschFifth Department of Medicine (Nephrology/Endocrinology/Rheumatology/Pneumology), University Medical Centre Mannheim, University of Heidelberg, Mannheim, ;Germany.
Bernhard K KrämerFifth Department of Medicine (Nephrology/Endocrinology/Rheumatology/Pneumology), University Medical Centre Mannheim, University of Heidelberg, Mannheim, ;Germany.
Georg A BöhmigDivision of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, ;Austria.
Carsten Müller-TidowDepartment of Hematology, Oncology and Rheumatology, Heidelberg University Hospital, Heidelberg, ;Germany.
Jochen ReiserDepartment of Medicine, Rush University, Chicago, IL, ;United States.
Martin ZeierDepartment of Nephrology, Heidelberg University Hospital, Heidelberg, ;Germany.
Michael SchmittDepartment of Hematology, Oncology and Rheumatology, Heidelberg University Hospital, Heidelberg, ;Germany.
Peter TernessInstitute of Immunology, Heidelberg University Hospital, Heidelberg, ;Germany.
Anita SchmittTolerogenixX GmbH, Heidelberg, ;Germany.
Volker DanielInstitute of Immunology, Heidelberg University Hospital, Heidelberg, ;Germany.
University Hospital Heidelberg · DEHeidelberg University · DEInstitute of Immunology · HRLudwig-Maximilians-Universität München · DEKlinikum Stuttgart · DEUniversity Medical Centre Mannheim · DEKoç University · TRMedical University of Vienna · ATRush University · USTiGenix (Spain) · ESUniversity Hospital Frankfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The administration of modified immune cells (MIC) before kidney transplantation led to specific immunosuppression against the allogeneic donor and a significant increase in regulatory B lymphocytes. We wondered how this approach affected the continued clinical course of these patients. Methods: Ten patients from a phase I clinical trial who had received MIC infusions prior to kidney transplantation were retrospectively compared to 15 matched standard-risk recipients. Follow-up was until year five after surgery. Results: The 10 MIC patients had an excellent clinical course with stable kidney graft function, no donor-specific human leukocyte antigen antibodies (DSA) or acute rejections, and no opportunistic infections. In comparison, a retrospectively matched control group receiving standard immunosuppressive therapy had a higher frequency of DSA (log rank Conclusions: MIC infusions together with reduced conventional immunosuppression were associated with good graft function during five years of follow-up, no Trial registration: https://clinicaltrials.gov/, identifier NCT02560220 (for the TOL-1 Study). EudraCT Number: 2014-002086-30.

Indexed as

Kidney TransplantationAntibodiesDisease ProgressionFollow-Up StudiesHumansProspective StudiesRetrospective StudiesAntibodiescell therapyphase I (drug development)regulatory B (Breg) cellstolerancetransplantation - kidney

Identifiers

PMID37483623
PMCPMC10361653
OpenAlexW4383597913

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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.