ISCT MSC committee statement on the US FDA approval of allogenic bone-marrow mesenchymal stromal cells.

The December 2024 US Food and Drug Administration (FDA) approval of Mesoblast's Ryoncil (remestemcel-L-rknd)-allogeneic bone marrow mesenchymal stromal cell (MSC(M)) therapy-in pediatric acute steroid-refractory graft-versus-host-disease finally ended a long-lasting drought on approved MSC clinical products in the United States. While other jurisdictions-including Europe, Japan, India, and South Korea-have marketed autologous or allogeneic MSC products, the United States has lagged in its approval. The sponsor's significant efforts and investments, working closely with the FDA addressing concerns regarding clinical efficacy and consistent MSC potency through an iterative process that spanned several years, was rewarded with this landmark approval.

Relationship between plasma urea and copeptin in response to arginine stimulation in healthy adults, patients with vasopressin deficiency and primary polydipsia.

Background: Arginine infusion stimulates copeptin secretion, a surrogate marker of arginine vasopressin (AVP), thereby serving as a diagnostic test in the differential diagnosis of suspected AVP deficiency (AVP-D). Yet, the precise mechanism underlying the stimulatory effect of arginine on the vasopressinergic system remains elusive. Arginine plays a significant role in the urea cycle and increases the production of urea.

Estimating self-performance when making complex decisions.

Metacognition, the ability to monitor and reflect on our own mental states, enables us to assess our performance at different levels - from confidence in individual decisions to overall self-performance estimates (SPEs). It plays a particularly important part in computationally complex decisions that require a high level of cognitive resources, as the allocation of such limited resources presumably is based on metacognitive evaluations. However, little is known about metacognition in complex decisions, in particular, how people construct SPEs.

Exploring force-driven stochastic folding dynamics in mechano-responsive proteins and implications in phenotypic variation.

Single-point mutations are pivotal in molecular zoology, shaping functions and influencing genetic diversity and evolution. Here we study three such genetic variants of a mechano-responsive protein, cadherin-23, that uphold the structural integrity of the protein, but showcase distinct genotypes and phenotypes. The variants exhibit subtle differences in transient intra-domain interactions, which in turn affect the anti-correlated motions among the constituent β-strands.

Protocol for a systematic review and individual participant data meta-analysis for risk factors for lung cancer in individuals with lung nodules identified by low-dose CT screening.

Background: Worldwide, lung cancer (LC) is the second most frequent cancer and the leading cause of cancer related mortality. Low-dose CT (LDCT) screening reduced LC mortality by 20-24% in randomised trials of high-risk populations. A significant proportion of those screened have nodules detected that are found to be benign.

Impact of SARS-CoV-2 spike antibody positivity on infection and hospitalisation rates in immunosuppressed populations during the omicron period: the MELODY study.

Background: In the UK, booster COVID-19 vaccinations have been recommended biannually to people considered immune vulnerable. We investigated, at a population level, whether the absence of detectable anti-SARS-CoV-2 spike protein IgG antibody (anti-S Ab) following three or more vaccinations in immunosuppressed individuals was associated with greater risks of infection and severity of infection.

Methods: In this prospective cohort study using UK national disease registers, we recruited participants with solid organ transplants (SOTs), rare autoimmune rheumatic diseases (RAIRDs), and lymphoid malignancies.

Stopping of adalimumab in juvenile idiopathic arthritis-associated uveitis (ADJUST): a multicentre, double-masked, randomised controlled trial.

Background: Adalimumab is an effective treatment for juvenile idiopathic arthritis-associated uveitis. Data are scarce on the effects of discontinuing adalimumab after control of the disease had been reached. We aimed to assess efficacy and safety of discontinuing treatment in patients with juvenile idiopathic arthritis-associated uveitis.

Unique considerations in the assessment and management of traumatic brain injury in older adults.

The age-specific incidence of traumatic brain injury in older adults is rising in high-income countries, mainly due to an increase in the incidence of falls. The severity of traumatic brain injury in older adults can be underestimated because of a delay in the development of mass effect and symptoms of intracranial haemorrhage. Management and rehabilitation in older adults must consider comorbidities and frailty, the treatment of pre-existing disorders, the reduced potential for recovery, the likelihood of cognitive decline, and the avoidance of future falls.

SynPull: An advanced method for studying neurodegeneration-related aggregates in synaptosomes using super-resolution microscopy.

Synaptic dysfunction is a primary hallmark of both Alzheimer's and Parkinson's disease, leading to cognitive and behavioral decline. While alpha-synuclein, beta-amyloid, and tau are involved in the physiological functioning of synapses, their pathological aggregation has been linked to synaptopathology. The methodology for studying the small-soluble protein aggregates formed by these proteins is limited.

A forward genetic screen identifies potassium channel essentiality in SHH medulloblastoma maintenance.

Distinguishing tumor maintenance genes from initiation, progression, and passenger genes is critical for developing effective therapies. We employed a functional genomic approach using the Lazy Piggy transposon to identify tumor maintenance genes in vivo and applied this to sonic hedgehog (SHH) medulloblastoma (MB). Combining Lazy Piggy screening in mice and transcriptomic profiling of human MB, we identified the voltage-gated potassium channel KCNB2 as a candidate maintenance driver.

Timing of adverse childhood experiences and depressive, anxiety, comorbid symptoms among Chinese female nurses: A life course perspective.

Background: Nurses demonstrate a greater vulnerability to developing depressive and anxiety symptoms compared to the general population. Adverse Childhood Experiences (ACEs) are known risk factors for mental health issues, but impact of timing of these experiences remains unclear.

Objective: To investigate associations between timing of ACEs and depressive, anxiety, comorbid symptoms.

Pro-cumulin addition in a biphasic in vitro oocyte maturation system modulates human oocyte and cumulus cell transcriptomes.

Biphasic in vitro oocyte maturation (IVM) can be offered as a patient-friendly alternative to conventional ovarian stimulation in in vitro fertilization (IVF) patients predicted to be hyper-responsive to ovarian stimulation. However, cumulative live birth rates after IVM per cycle are lower than after conventional ovarian stimulation for IVF. In different animal species, supplementation of IVM media with oocyte-secreted factors (OSFs) improves oocyte developmental competence through the expression of pro-ovulatory genes in cumulus cells.

Human Metapneumovirus: an emerging respiratory pathogen and the urgent need for improved Diagnostics, surveillance, and vaccine development.

Human Metapneumovirus (HMPV) is a re-emerging respiratory pathogen causing significant morbidity and mortality, particularly among young children, the elderly, and immunocompromised individuals. First identified in 2001, HMPV has since been recognised as a leading cause of acute respiratory tract infections (ARTIs) worldwide. Its transmission occurs through droplets, direct contact, and surface contamination, with crowded spaces and healthcare facilities serving as key environmental amplifiers.

All-solid Conductive Elastomers Bridging Mechanical Performance and Sustainability for Durable and Multifunctional Electronics.

The next generation of stretchable electronics seeks to integrate superior mechanical properties with sustainability and sensing stability. Ionically conductive and liquid-free elastomers have gained recognition as promising candidates, addressing the challenges of evaporation and leakage in gel-based conductors. In this study, a sustainable polymeric deep eutectic system is synergistically integrated with amino-terminated hyperbranched polyamide-modified fibers and aluminum ions, forming a conductive supramolecular network with significant improvements in mechanical performance.

'It is scary to pause treatment': perspectives on HIV cure-related research and analytical treatment interruptions from women diagnosed during acute HIV in Durban, South Africa.

Background: HIV remains a major challenge in KwaZulu-Natal, South Africa, particularly for young women who face disproportionate risks and barriers to prevention and treatment. Most HIV cure trials, however, occur in high-income countries.

Objective: To examine the perspectives of young women diagnosed with acute HIV in a longitudinal study, focusing on their perceptions on ATI-inclusive HIV cure trials and the barriers and facilitators to participation.

2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry ( - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV).

The 18 Workshop on Recent Issues in Bioanalysis (18 WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

The 18 Workshop on Recent Issues in Bioanalysis (18 WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).

The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

The Association Between Egg and Egg-Derived Cholesterol Consumption, and Their Change Trajectories, with Obesity Among Chinese Adults: Results from the China Health and Nutrition Survey.

As a widely consumed, nutritious, and affordable food, eggs and their derivatives' impacts on obesity remain inconclusive. In this study, we aimed to determine the association between egg and egg-derived cholesterol consumption, and their change trajectories, with obesity among Chinese adults. : Longitudinal data collected by the China Health and Nutrition Survey from 1997 to 2015 were analyzed.

Associations Between Adherence to the Mediterranean Diet and Incident Sarcopenia in Prospective Cohort Studies.

The loss of skeletal muscle mass and strength, known as sarcopenia, is prevalent in older adults and linked to an increased risk of disability, frailty, and early mortality. Muscle health is crucial for the functionality and independence of older adults. As the aging population continuously grows, finding cost-effective strategies for preventing and treating sarcopenia is an important public health priority.

The Application of Olive-Derived Polyphenols on Exercise-Induced Inflammation: A Scoping Review.

Background/objectives: There is current scientific interest pertaining to the therapeutic effects of olive-derived polyphenols (ODPs), in particular their associated anti-inflammatory properties, following the wealth of research surrounding the physiological impact of the Mediterranean Diet (MD). Despite this association, the majority of the current literature investigates ODPs in conjunction with metabolic diseases. There is limited research focusing on ODPs and acute inflammation following exercise, regardless of the knowledge surrounding the elevated inflammatory response during this time.

Characterization of RAP Signal Patterns, Temporal Relationships, and Artifact Profiles Derived from Intracranial Pressure Sensors in Acute Traumatic Neural Injury.

Goal: Current methodologies for assessing cerebral compliance using pressure sensor technologies are prone to errors and issues with inter- and intra-observer consistency. RAP, a metric for measuring intracranial compensatory reserve (and therefore compliance), holds promise. It is derived using the moving correlation between intracranial pressure (ICP) and the pulse amplitude of ICP (AMP).

Towards the Measurement of Sea-Ice Thickness Using a Time-Domain Inductive Measurement System.

Frequency-domain electromagnetic induction (EMI) is routinely used to detect the presence of seawater due to the inherent electrical conductivity of the seawater. This approach is used to infer sea-ice thickness (SIT). A time-domain EMI sensor is presented, which demonstrates the potential for correlating the spectroscopic properties of the received signal with the distance to the sea surface.

The Evaluation and Modification of Standard Airway Assessment Tests for Virtual Anaesthetic Assessments: A Pilot Study.

Virtual preoperative anaesthetic assessments can significantly reduce healthcare costs and improve patient convenience. The challenge with virtual consults is often the airway assessments, which screen for potentially difficult airways (PDAs). The objective of this pilot study was to determine the reliability of standard airway screening tests for detecting PDAs when conducted virtually.