Trial reportJournal of translational medicine2010
The application of adjuvant autologous antravesical macrophage cell therapy vs. BCG in non-muscle invasive bladder cancer: a multicenter, randomized trial.
Trial report in Journal of translational medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.
- BCG Intolerance in Nonmuscle Invasive Bladder Cancer-A Systematic Review.ANZ journal of surgery · 2025Pooled it
- Immunity and Beyond: Emerging Roles of Monocytes and Macrophages in Cancer.Advances in experimental medicine and biology · 2026Review
- Prospects of Synergy: Local Interventions and CAR T Cell Therapy in Solid Tumors.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
- Engineering approaches for innate immune-mediated tumor microenvironment remodeling.Immuno-oncology technology · 2024Review
- Intratumoral adoptive transfer of inflammatory macrophages engineered by co-activating TLR and STING signaling pathways exhibits robust antitumor activity.Clinical and experimental medicine · 2023Article
- Efficacy evaluation of chimeric antigen receptor-modified human peritoneal macrophages in the treatment of gastric cancer.British journal of cancer · 2023Article
- Adoptive cellular immunotherapy for solid neoplasms beyond CAR-T.Molecular cancer · 2023Review
- Racing CARs to veterinary immuno-oncology.Frontiers in veterinary science · 2023Review
- CDKN1A is a target for phagocytosis-mediated cellular immunotherapy in acute leukemia.Nature communications · 2022Article
- Induced overexpression of MARCH-1 in human macrophages altered to M2 phenotype for suppressing inflammation process.Iranian journal of basic medical sciences · 2022Article
- Adoptive Cell Therapy in Pediatric and Young Adult Solid Tumors: Current Status and Future Directions.Frontiers in immunology · 2022Review
- Review
- Article
- Defining Genome-Wide Expression and Phenotypic Contextual Cues in Macrophages Generated by Granulocyte/Macrophage Colony-Stimulating Factor, Macrophage Colony-Stimulating Factor, and Heat-Killed Mycobacteria.Frontiers in immunology · 2017Article
- Macrophage-based cell therapies: The long and winding road.Journal of controlled release : official journal of the Controlled Release Society · 2016Review
- Phenotypic and functional characterization of macrophages with therapeutic potential generated from human cirrhotic monocytes in a cohort study.Cytotherapy · 2015Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 16 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionWhile adjuvant immunotherapy with Bacille Calmette Guérin (BCG) is effective in non-muscle-invasive bladder cancer (BC), adverse events (AEs) are considerable. Monocyte-derived activated killer cells (MAK) are discussed as essential in antitumoural immunoresponse, but their application may imply risks. The present trial compared autologous intravesical macrophage cell therapy (BEXIDEM) to BCG in patients after transurethral resection (TURB) of BC. MATERIALS AND
methodsThis open-label trial included 137 eligible patients with TaG1-3, T1G1-2 plurifocal or unifocal tumours and >or=2 occurrences within 24 months and was conducted from June 2004 to March 2007. Median follow-up for patients without recurrence was 12 months. Patients were randomized to BCG or mononuclear cells collected by apheresis after ex vivo cell processing and activation (BEXIDEM). Either arm treatment consisted of 6 weekly instillations and 2 cycles of 3 weekly instillations at months 3 and 6. Toxicity profile (primary endpoint) and prophylactic effects (secondary endpoint) were assessed.
resultsPatient characteristics were evenly distributed. Of 73 treated with BCG and 64 with BEXIDEM, 85% vs. 45% experienced AEs and 26% vs. 14% serious AEs (SAE), respectively (p<0.001). Recurrence occurred significantly less frequent with BCG than with BEXIDEM (12% vs. 38%; p<0.001). DISCUSSION: This initial report of autologous intravesical macrophage cell therapy in BC demonstrates BEXIDEM treatment to be safe. Recurrence rates were significantly lower with BCG however. As the efficacy of BEXIDEM remains uncertain, further data, e.g. marker lesions studies, are warranted.
trial registrationThe trial has been registered in the ISRCTN registry http://isrctn.org under the registration number ISRCTN35881130.
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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.