Protocol for a first-in-human feasibility study of T regulatory cells (TR004) for inflammatory bowel disease using (ex vivo) Treg expansion (TRIBUTE).

Introduction: Crohn's disease (CD) is a chronic, immune-mediated inflammatory bowel disease (IBD), presenting with symptoms of abdominal pain and bleeding from the gastrointestinal tract. There is no known cure. In vitro-expanded 'thymus-derived' regulatory T cells (tTreg) have shown promise in preclinical models of IBD, leading to interest in their use as a potential therapy in CD.

Longitudinal change in ultrasound-derived rectus femoris cross-sectional area in COPD.

Background: Skeletal muscle dysfunction is common in COPD. Ultrasound-derived rectus femoris cross-sectional area (RFCSA) is a radiation free, non-invasive measure of muscle bulk that relates to quadriceps strength in people with COPD. However, there are limited longitudinal data for RFCSA, and it is not known whether longitudinal change in RFCSA reflects change in quadricep strength, exercise capacity, lower limb function or muscle mass.

Considerations for Colorectal Neoplasia Detection in Inflammatory Bowel Disease Clinical Trials.

Background: High-quality colonoscopic surveillance can lead to earlier and increased detection of colorectal neoplasia in patients with inflammatory bowel disease (IBD). In IBD clinical trials, endoscopy is used to assess mucosal disease activity before and after treatment but also provides an opportunity to surveil for colorectal neoplasia during follow-up.

Summary: Best practices for colorectal cancer identification in IBD clinical trials require engagement and collaboration between the clinical trial sponsor, site endoscopist and/or principal investigator, and central read team.

Efficacy and Safety of Approximately 3 Years of Continuous Ozanimod in Moderately to Severely Active Ulcerative Colitis: Interim Analysis of the True North Open-label Extension.

Backgrounds And Aims: This interim analysis from the True North open-label extension [OLE] study examines efficacy and safety of approximately 3 years of continuous ozanimod treatment in patients with moderately to severely active ulcerative colitis.

Methods: Clinical responders after 52 weeks of ozanimod during the phase 3 True North study, who continued treatment in the OLE, were evaluated. Efficacy, including endoscopic and histological endpoints, was assessed during the OLE for approximately 2 additional years through OLE Week 94, using observed case [OC] and nonresponder imputation [NRI] analyses.

Intereye Differences in the Clinical Assessment of Intraocular Pressure and Ocular Biomechanics.

Significance: Clinicians and researchers will have evidence whether intereye differences confound clinical measurements of intraocular pressure or of ocular biomechanical parameters.

Purpose: The purpose of this study was to determine whether intraocular pressure and biomechanical parameters, as measured by the Ocular Response Analyzer (ORA) and by Cornea Visualization with Scheimpflug Technology (CorVis ST), are different between the first and second eye measured.

Methods: Intraocular pressure and biomechanical parameters were collected from both eyes of healthy participants (N = 139).