ArticleTrials2025
Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis-2 (AuToDeCRA-2) study: protocol for a single-centre, experimental medicine study investigating the route of delivery and potential efficacy of autologous tolerogenic dendritic cell (TolDC) therapy for rheumatoid arthritis.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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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
6 citing papers in PubMed.
- Challenges of experimental medicine studies.Clinical rheumatology · 2026Article
- Dendritic cells as orchestrators in the allergen-specific immunotherapy of allergic diseases.Clinical reviews in allergy & immunology · 2026Review
- Immune reset and immune retune: approaching cure?Nature reviews. Rheumatology · 2026Article
- HLA class I-naturally presented synovial tissue peptides are recognized by CD8+ T lymphocytes from rheumatoid arthritis patients.Frontiers in immunology · 2026Article
- Sustained microparticle-mediated intracellular immunomodulation enhances tolerogenic dendritic cell stability and antigen-specific Treg induction.Frontiers in immunology · 2026Article
- Restoring Immunological Tolerance via Dendritic Cells in Rheumatoid Arthritis.European journal of immunology · 2026Review
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Authors and funding
17 authors.
Funding
Abstract
backgroundDendritic cells are professional antigen presenting cells with the ability, in their immature state, to induce tolerance in T cells. A protocol to develop phenotypically stable tolerogenic dendritic cells (TolDC) was developed in Newcastle and cells administered to participants in the phase I AuToDeCRA study, demonstrating that TolDC were safe and well tolerated. More knowledge of the TolDC product is now needed, such as optimal dose, route of administration and antigen loading. Establishing this and developing a biomarker profile to demonstrate favourable immunomodulation is the focus of AuToDeCRA-2.
methodsAuToDeCRA-2 is a non-commercial, phase IIa, 5-arm, randomised, unblinded, single-centre study. It is designed to demonstrate and compare immunomodulation achieved by TolDC administered via three distinct routes: intra-nodal, intra-articular, intra-dermal and, in the case of intra-nodal administration, at 2 doses. Participants will be randomised to one of these four active intervention arms or standard care. Participants in intervention arms will receive a single dose of TolDC loaded with synthetic citrullinated peptides (TolDC DISCUSSION: TolDC therapy is an emerging cellular therapy aimed at reversing the underlying abnormality in autoimmune disease by inducing tolerance to autoantigen. Expected challenges to this study include recruitment of potentially asymptomatic participants to a complex and intensive experimental medicine study. Limitations include the relatively small number of participants although adequate to address the aims of the study. Establishing acceptable route(s) of administration as well as demonstrating favourable immunomodulation via the development of a biomarker profile is the focus of AuToDeCRA-2, which aims to address some of the existing scientific gaps necessary for the development of TolDC therapy in autoimmune disease.
trial registrationISRCTN, ISRCTN14999554. Registered on 27th September 2023.
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