Trial reportGastroenterology2012
Safety and efficacy of antigen-specific regulatory T-cell therapy for patients with refractory Crohn's disease.
Trial report in Gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02327221 (A Phase IIb, Multicentre, Randomised, Double-blinded, Placebo-controlled, Multi-dose and Multi-injection, Parallel Groups Study to Evaluate the Efficacy and the Safety of Ovasave in Patients With Active Refractory Crohn's Disease), which is not on this map. Cited by 227 papers, 1 of them a synthesis that pooled it.
What it found
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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.
A Phase IIb, Multicentre, Randomised, Double-blinded, Placebo-controlled, Multi-dose and Multi-injection, Parallel Groups Study to Evaluate the Efficacy and the Safety of Ovasave in Patients With Active Refractory Crohn's Disease
Who cites it
227 citing papers in PubMed, 1 synthesis or guideline pooled it, 372 citations in OpenAlex.
- Emerging CAR-Treg and regulatory T cell therapies for inflammatory bowel diseases: a systematic review of a new era of treatment.Frontiers in immunology · 2026Pooled it
- Nonclinical safety assessment of SBT777101, a CAR-engineered regulatory T cell therapy for autoimmune diseases.Toxicological sciences : an official journal of the Society of Toxicology · 2026Article
- Engineering immune cell therapies for inflammatory bowel disease: from stem cells to CAR T cells.Nature reviews. Gastroenterology & hepatology · 2026Review
- Review
- Review
- Review
- Vortex-actuated pre-enrichment accelerates human regulatory T cell sorting and improves early fitness.Molecular therapy. Advances · 2026Article
- Are All Cells Created Equal? Novel Cell-Based Regenerative Therapies in Inflammatory Bowel Disease.International journal of molecular sciences · 2026Review
- Cytokines Associated with Activation of CD4International journal of molecular sciences · 2026Review
- Characteristics of T-Cells Expressing IL-37 and Its Receptors in Inflammatory Bowel Disease.International journal of molecular sciences · 2026Article
- Chimeric antigen receptor technology: an emerging translational immunotherapy in nonneoplastic diseases.Frontiers in immunology · 2026Review
- Regulatory T cell therapy in autoimmune and immune-mediated diseases: from basic research to clinical practice and future perspectives.Frontiers in immunology · 2026Review
- Regulatory T cell therapies: biological foundations, engineering strategies, and clinical translation.Frontiers in immunology · 2026Review
- FOXP3 Stability-Adaptation Paradox: Reshaping Treg-Based Therapies for Intestinal Diseases.International journal of biological sciences · 2026Review
- Engineering allogeneic type 1 regulatory T cells: a scalable, off-the-shelf platform for restoring immune tolerance.Frontiers in immunology · 2026Article
- T Regulatory Cells in Inflammatory Bowel Disease-Are They Major Players?International journal of molecular sciences · 2025Review
- Gut microbiota in regulatory T cell generation and function: mechanisms and health implications.Gut microbes · 2025Review
- Regulatory T cell therapy for Sjögren's disease: From pathogenesis to targeted treatment.Journal of translational autoimmunity · 2025Review
- The Potential of β-Synuclein-Specific Regulatory T Cell Therapy as a Treatment for Progressive Multiple Sclerosis.International journal of molecular sciences · 2025Review
- Pathogenic drivers of lupus myocarditis and potential therapeutic targets.Experimental & molecular medicine · 2025Review
167 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
17 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
aimsNew therapeutic strategies are needed for patients with refractory Crohn's disease (CD). We evaluated data from the Crohn's And Treg Cells Study (CATS1) to determine the safety and efficacy of antigen-specific T-regulatory (Treg) cells for treatment of patients with refractory CD.
methodsWe performed a 12-week, open-label, multicenter, single-injection, escalating-dose, phase 1/2a clinical study in 20 patients with refractory CD. Ovalbumin-specific Treg cells (ova-Tregs) were isolated from patients' peripheral blood mononuclear cells (PBMCs), exposed to ovalbumin, and administrated intravenously. Safety and efficacy were assessed using clinical and laboratory parameters. We evaluated proliferation of PBMCs in response to ovalbumin.
resultsInjections of ova-Tregs were well tolerated, with 54 adverse events (2 related to the test reagent) and 11 serious adverse events (3 related to the test reagent, all recovered). Overall, a response, based on a reduction in Crohn's Disease Activity Index (CDAI) of 100 points, was observed in 40% of patients at weeks 5 and 8. Six of the 8 patients (75%) who received doses of 10(6) cells had a response at weeks 5 and 8, with a statistically significant reduction in CDAI. In this group, remission (based on CDAI ≤150) was observed in 3 of 8 patients (38%) at week 5 and 2 of 8 patients (25%) at week 8.
conclusionsAdministration of antigen-specific Tregs to patients with refractory CD (CATS1) was well tolerated and had dose-related efficacy. The ovalbumin-specific immune response correlated with clinical response, supporting immune-suppressive mechanisms of ova-Tregs. The consistency of results among different assessment methods supports the efficacy of ova-Tregs; this immune therapy approach warrants further clinical and mechanistic studies in refractory CD. Eudract, Number: 2006-004712-44.
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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.