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First-in-human trial of atrial fibrillation ablation using real time tissue optical assessment to predict pulsed field lesion durability.
Europace
January 2025
Division of Cardiology, McGill University Medical Center, Montreal, Quebec, Canada.
Background: Loss of bipolar electrograms immediately after pulsed field ablation (PFA) makes lesion durability assessment challenging.
Objective: The aim of this trial (NCT06700226) was to evaluate a novel ablation system that can optically predict lesion durability by detecting structural changes in the tissue during ablation.
Methods: Patients with paroxysmal atrial fibrillation underwent pulmonary vein isolation (PVI) using PFA (AblaView®, MedLumics).
Synthesis, Preclinical Evaluation, and First-in-Human Assessment of ICG-PSMA-D5: A PSMA-Targeted Probe for Fluorescence-Guided Surgery of Prostate Cancer.
J Med Chem
January 2025
Key Laboratory of Radiopharmaceuticals, Ministry of Education, College of Chemistry, Beijing Normal University, Beijing 100875, China.
Precise surgical resection of prostate cancer (PCa) is a significant clinical challenge due to the impact of positive surgical margins on postoperative outcomes. Fluorescence-guided surgery (FGS) enables real-time tumor visualization using fluorescent probes. In this study, we synthesized and evaluated an indocyanine green (ICG)-based PSMA-targeted near-infrared probe, , for intraoperative imaging of PCa lesions.
View Article and Find Full Text PDFSafety and performance of a novel synthetic biomimetic scaffold for iliac crest defect reconstruction during surgical treatment of pelvic girdle pain: a first-in-human trial.
Br Med Bull
January 2025
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Introduction: Surgical treatment of pelvic girdle pain (PGP) involves arthrodesis of sacroiliac (SI) and pubic symphysis joints. Fusion of pubic symphysis involves the implantation of an autologous iliac crest tricortical graft harvested from the iliac crest. The objective was to assess the safety of a novel synthetic graft substitute (b.
View Article and Find Full Text PDFQuality and Regulatory Requirements for the Manufacture of Master Cell Banks of Clinical Grade iPSCs: The EU and USA Perspectives.
Stem Cell Rev Rep
January 2025
Faculty of Pharmacy, Universidade de Lisboa, Av. Prof. Gama Pinto, 1649-003, Lisboa, Portugal.
The discovery of induced pluripotent stem cells (iPSCs) and protocols for their differentiation into various cell types have revolutionized the field of tissue engineering and regenerative medicine. Developing manufacturing guidelines for safe and GMP-compliant final products has become essential. Allogeneic iPSCs-derived cell therapies are now the preferred manufacturing alternative.
View Article and Find Full Text PDFBI 1703880, a novel STimulator of INterferon Genes (STING) agonist, has demonstrated preclinical antitumor activity. As STING activation can upregulate programmed death ligand 1 and human leukocyte antigen in tumor cells, a combination of BI 1703880 and an anti-programmed cell death protein 1-antibody, such as ezabenlimab, may improve efficacy. This first-in-human phase Ia study (NCT05471856) is evaluating BI 1703880 plus ezabenlimab in patients with advanced solid tumors.
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