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.

Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial.

Encorafenib + cetuximab (EC) is approved for previously treated BRAF V600E-mutant metastatic colorectal cancer (mCRC) based on the BEACON phase 3 study. Historically, first-line treatment of BRAF V600E-mutant mCRC with chemotherapy regimens has had limited efficacy. The phase 3 BREAKWATER study investigated EC+mFOLFOX6 versus standard of care (SOC) in patients with previously untreated BRAF V600E mCRC.

Exploratory study of patients' and carers' preferences for postdischarge surgical wound monitoring using survey and interviews.

Objectives: To explore patients' and carers' preferences for postdischarge surgical wound monitoring.

Design: Explanatory mixed methods study with an online survey followed by online interviews.

Setting: The online survey was distributed via the Cardiothoracic Interdisciplinary Research Network and cardiac surgery patient and public involvement groups in London and Leicester, UK.

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.

Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver disease.

Background & Aims: Current guidelines recommend a 2-step approach for risk stratification in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) with Fibrosis-4 index (FIB-4) followed by liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) or similar second-line tests. This study aimed to examine to prognostic performance of this approach.

Methods: The VCTE-Prognosis Study was a longitudinal study of patients with MASLD who had undergone VCTE examinations at 16 centres from the US, Europe and Asia with subsequent follow-up for clinical events.

Leveraging Epigenetic Alterations in Pancreatic Ductal Adenocarcinoma for Clinical Applications.

Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive malignancy characterized by late detection and poor prognosis. Recent research highlights the pivotal role of epigenetic alter- ations in driving PDAC development and progression. These changes, in conjunction with genetic mutations, contribute to the intricate molecular landscape of the disease.

Advancing medication compounding: Use of a pharmaceutical 3D printer to auto-fill minoxidil capsules for dispensing to patients in a community pharmacy.

Compounding medications in pharmacies is a common practice for patients with prescriptions that are not available commercially, but it is a laborious and error-prone task. The incorporation of emerging technologies to prepare personalised medication, such as 3D printing, has been delayed in smaller pharmacies due to concerns about potential workflow disruptions and learning curves associated with novel technologies. This study examines the use in a community pharmacy of a pharmaceutical 3D printer to auto-fill capsules and blisters using semisolid extrusion, incorporating an integrated quality control system.

Dynamic cycles between brain states during creative storytelling.

Many theories suggest that creative thinking involves a dynamic transition between different mental states, yet empirical evidence supporting this notion remains scarce. The dual process model proposes that spontaneous thinking and deliberate thinking drive the dwell in and the transitions between different mental states during creative thinking, but there is a debate over whether the two types of thinking operate in parallel or in sequence. To address these gaps, we conducted a functional magnetic resonance imaging (fMRI) study in 41 college students during a creative storytelling task.

Specific symptomatology profile associated with treatment resistant depression: A multicentric study from the Group for the Study of Resistant Depression with a focus on sex.

Background: Clinical predictors of treatment-resistant depression could improve treatment strategies. Depressive symptom profiles at baseline are potential outcome predictors, but little evidence is available, and sex-specific profiles have been scarcely investigated.

Methods: Baseline symptom scores of 1294 patients with major depressive disorder were assessed by the Montgomery-Åsberg depression rating scale (MADRS) as part of a multicenter study by the "Group for the Studies of Resistant Depression".

A mixed method evaluation of a novel targeted health messaging intervention to promote COVID-19 protective behaviours and vaccination among Black and South Asian communities living in the UK (The COBHAM study).

Aim: To evaluate an intervention (a film and electronic leaflet) disseminated via text message by general practices to promote COVID-19 preventative behaviours in Black and South Asian communities.

Methods: We carried out a before-and-after questionnaire study of attitudes to and implementation of COVID-19 preventative behaviours and qualitative interviews about the intervention with people registered with 26 general practices in England who identified as Black or South Asian.

Results: In the 108 people who completed both questionnaires, we found no significant change in attitudes to and implementation of COVID-19 preventative behaviours, although power was too low to detect significant effects.

Dosimetric comparison of CyberKnife and conventional linac prostate SBRT plans: analysis of the PACE-B Study.

Purpose: In the PACE-B study, a non-randomised comparison of toxicity outcomes between stereotactic body radiotherapy (SBRT) platforms revealed fewer urinary side-effects with CyberKnife (CK) compared to conventional linac (CL) SBRT. This analysis compares baseline characteristics and planning dosimetry between the CK-SBRT and CL-SBRT cohorts in PACE-B, aiming to provide insight into possible reasons for differing toxicity outcomes between the platforms.

Methods: Dosimetric parameters for the surrogate urethra (SU), contoured urethra, bladder, bladder trigone (BT), and rectum were extracted from available CT planning scans of PACE-B SBRT patients.

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.

Grandparental childcare and subjective well-being: The role of activities and reasons for care.

Despite extensive research on the impact of grandchild care on grandparents' well-being, no studies have examined the frequency of activities that grandparents engage in with their grandchildren or the reasons for care using nationally representative data. We address this gap using waves 8 (2016/2017) and 9 (2018/19) of the English Longitudinal Study of Ageing, a nationally representative study of English older adults. We employ hybrid regression models to distinguish between within- and between-individual effects on grandparents' subjective wellbeing, as captured by quality of life and depressive symptoms.

Flies as carriers of antimicrobial resistant (AMR) bacteria in Nigerian hospitals: A workflow for surveillance of AMR bacteria carried by arthropod pests in hospital settings.

The dissemination of antimicrobial resistant (AMR) bacteria by flies in hospitals is concerning as nosocomial AMR infections pose a significant threat to public health. This threat is compounded in low- and middle-income countries (LMICs) by several factors, including limited resources for sufficient infection prevention and control (IPC) practices and high numbers of flies in tropical climates. In this pilot study, 1,396 flies were collected between August and September 2022 from eight tertiary care hospitals in six cities (Abuja, Enugu, Kaduna, Kano, Lagos and Sokoto) in Nigeria.

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.

MetAssimulo 2.0: a web app for simulating realistic 1D & 2D Metabolomic 1H NMR spectra.

Unlabelled: Metabolomics extensively utilizes Nuclear Magnetic Resonance (NMR) spectroscopy due to its excellent reproducibility and high throughput. Both one-dimensional (1D) and two-dimensional (2D) NMR spectra provide crucial information for metabolite annotation and quantification, yet present complex overlapping patterns which may require sophisticated machine learning algorithms to decipher. Unfortunately, the limited availability of labeled spectra can hamper application of machine learning, especially deep learning algorithms which require large amounts of labelled data.

Extreme heat risk and the potential implications for the scheduling of football matches at the 2026 FIFA World Cup.

Climate change is making extreme heat events more frequent and intense. This negatively impacts many aspects of society, including organised sport. As the world's most watched sporting event, the FIFA World Cup commands particular attention around the threat of extreme heat.

Abdominopelvic imaging in the follow-up of testicular germ-cell tumors in adults: recommendations of the Scrotal and Penile Imaging Working Group of the European Society of Urogenital Radiology.

Objectives: The Scrotal and Penile Imaging Working Group (SPIWG) of the European Society of Urogenital Radiology (ESUR) aimed to formulate recommendations on the imaging modalities and minimal technical requirements for abdominopelvic imaging in the follow-up of adult patients treated for testicular germ-cell tumors (TGCT).

Methods: The SPIWG members performed an extensive literature search, reviewed the current clinical practice, and reached a consensus based on the opinions of experts in the field.

Results: Recurrence in patients treated for TGCT mainly occurs in retroperitoneal lymph nodes (LNs).

Distribution of informal caregiving for older adults living with or at risk of cognitive decline within and beyond family in rural South Africa.

Objectives: Aging populations will increasingly need care, much of this provided informally particularly in rural areas and in low and middle-income countries. In rural South Africa, formal support is severely limited, and adult children are frequently unavailable due to morbidity, early mortality, employment and migration. We describe how care is shared within and between households.

The 100 most-cited articles in WALANT hand surgery: A bibliometric and visualized analysis.

This bibliometric analysis aimed to define important topics and developments across wide awake local anaesthesia no tourniquet (WALANT) hand surgery, an innovative ambulatory technique that gained popularity during the COVID-19 pandemic. Articles were searched and screened using the Web of Science core collection database. VOSviewer 1.

'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.