Asparagine Dependency is a Targetable Metabolic Vulnerability in TP53-Altered Castration-Resistant Prostate Cancer.

The TP53 tumor suppressor is frequently altered in lethal, castration-resistant prostate cancer (CRPC). However, to date there are no effective treatments that specifically target TP53 alterations. Using transcriptomic and metabolomic analyses, we showed here that TP53-altered prostate cancer (PCa) exhibits an increased dependency on asparagine and overexpresses asparagine synthetase (ASNS), the enzyme catalyzing the synthesis of asparagine. Mechanistically, loss or mutation of TP53 transcriptionally activated ASNS expression, directly as well as via mTORC1-mediated ATF4 induction, driving de novo asparagine biosynthesis to support CRPC growth. TP53-altered CRPC cells were sensitive to asparagine restriction by knockdown of ASNS or L-asparaginase treatment to deplete the intracellular and extracellular sources of asparagine, respectively, and cell viability was rescued by asparagine addition. Notably, pharmacological inhibition of intracellular asparagine biosynthesis using a glutaminase inhibitor and depletion of extracellular asparagine with L-asparaginase significantly reduced asparagine production and effectively impaired CRPC growth. This study highlights the significance of ASNS-mediated metabolic adaptation as a synthetic vulnerability in CRPC with TP53 alterations, providing a rationale for targeting asparagine production to treat these lethal prostate cancers.

Effect of nanoplastic intake on the dopamine system during the development of male mice.

Exposure to environmental microplastics has been demonstrated to impact health. However, its effect on development remains unclear. This study investigated whether consumption of nanoplastics (NPx) during development affects social and cognitive functions in rodents. In this study, we utilized male Institute of Cancer Research mice; they were divided into five subgroups based on the duration of NPx administration. NPx (100 nm) was orally administered via gavage for 6 days from gestational day (GTD) 7, representing the mid-gestation period, and for 5-6 days from GTD13 to birth, representing the late-gestation period; the male offspring were used for experiments. NPx was orally administered for 15 days starting at postnatal day (PND) 21 as the juvenile, PND38 as the adolescent, and PND56 as adulthood. On PND77, offspring were assessed for locomotion, social behavior, and nest-building tests. We observed that NPx administration altered dopamine system responses in GTD13 and PND56 groups. Social behavior was similarly affected by NPx treatment, with GTD13 and PND56 groups displaying decreased familiarity. Additionally, NPx treatment enhanced local field potentials in the prefrontal cortex, nucleus accumbens, and amygdala of GTD7 group and in the striatum of GTD13 group, while amphetamine treatment induced changes of local field potentials compared to saline treatment in the prefrontal cortex and the ventral tegmental area of CTR, GTD7, PND21, and PND56 groups. Taken together, these results showed that NPx treatment induced changes in social behavior partly depending on developmental stage, and these changes are associated with neural circuits innervated by the dopamine system.

UK Cancer Healthcare Professionals Collaborating With Colleagues in Low- and Middle-Income Countries: Mapping the Extent and Nature of Partnerships; Future Implications.

AIMS: In 2020 the UK Global Cancer Network (UKGCN) was formed to unite those in the UK interested in Global Oncology and to strengthen collaborative partnerships with stakeholders working across low- and middle-income countries (LMICs) in cancer health systems, governance, and care. The UKGCN undertook a mapping exercise to document collaborations to inform the UK's global oncology strategy. MATERIALS AND METHODS: A semi-structured survey was developed and disseminated using a snowball method over ten weeks from February 2021 across the UK's cancer community, to identify individuals and institutions engaged in clinical practice, research, and/or education with partners in LMICs. The survey was sent to individuals in NHS hospitals, charities, universities, other organisations, UKGCN members, and to contacts identified by a literature and web search. RESULTS: A total of 639 invitations were sent, and 88 responses were received. Results demonstrate a range of collaborative efforts spanning many areas of cancer control: health promotion, prevention, diagnosis and treatment, survivorship, and palliative care. A wide range of countries were represented from Sub-Saharan Africa, South America, the MENA region, China, and South-East Asia. The projects included education and training (146), clinical practice/care (144), and research (226). CONCLUSION: This mapping exercise demonstrated considerable UK collaboration with stakeholders in LMICs across all three domains of education, clinical care, and research. The survey results provide an initial framework from which to promote in-depth strategic intelligence on the broad range of activities undertaken by the UK global oncology community. This information has been used as a catalyst to create new partnerships and connect colleagues working in similar geographical settings, encouraging bidirectional learning. The UKGCN will galvanise endeavours to improve equitable access to cancer services globally.

Safety assessment of cocamidopropyl betaine, a cosmetic ingredient.

Cocamidopropyl betaine (CAPB) is a surfactant derived from coconut oil that is widely used in cosmetics and personal products for several purposes, such as a surfactant, foam booster, mildness, and viscosity control. Cocamidopropyl betaine is used at concentrations up to 30% in cosmetics. The acute toxicity, skin irritation, eye irritation, skin sensitization, repeated dose toxicity, genotoxicity, carcinogenicity, and phototoxicity of cocamidopropyl betaine were evaluated. Cocamidopropyl betaine was observed to induce mild skin irritation, eye irritation and skin sensitization. The NOAEL of cocamidopropyl betaine was determined to be 250 mg/kg/day based on the results of a 92-day repeated-dose oral toxicity study in rats. The systemic exposure dose of cocamidopropyl betaine was estimated to range from 0.00120 to 0.93195 mg/kg/day when used in cosmetic products. The margin of safety of cocamidopropyl betaine was calculated to be greater than 100 when used at a maximum concentration of 6% in leave-on products and 30% in rinse-off products, suggesting that its use in cosmetic products is safe under current usage conditions.

Self-assembly of Ni(II) with a chiral ligand pair vs. mixture of the chiral ligand pair: structural features and recognition ability of Ni2L4 cages.

The self-assembly of NiCl2 with a chiral bidentate ligand pair, (1R,2S)-(+)- and (1S,2R)-(-)-1-(nicotinamido)-2,3-dihydro-1H-inden-2-yl nicotinate (r,s-L and s,r-L) in a mixture of ethanol and dioxane, gives rise to stable crystals consisting of [2Cl@Ni2Cl2(s,r-L)4(H2O)2]·4C4H8O2·EtOH and [2Cl@Ni2Cl2(r,s-L)4(H2O)2]·4C4H8O2·EtOH chiral cages, respectively, with two encapsulated chloride anions in the cavities. The most interesting feature is that the self-assembly of NiCl2 with the mixture of r,s-L and s,r-L (1 : 1-1 : 4) produces crystals of thermodynamically stable achiral cages, [2Cl·2H2O@Ni2Cl2(s,r-L)2(r,s-L)2(H2O)2]·7C4H8O2, in the molar ratio range. Furthermore, the [2Cl@Ni2Cl2(s,r-L)4(H2O)2]·4C4H8O2·EtOH and [2Cl@Ni2Cl2(r,s-L)4(H2O)2]·4C4H8O2·EtOH chiral crystals can recognize the pairs of L-,D-tryptophan and L-,D-cysteine via cyclic voltammetry (CV) signals, in contrast to the [2Cl·2H2O@Ni2Cl2(s,r-L)2(r,s-L)2(H2O)2]·7C4H8O2 achiral crystal.

Factors Affecting Abdominal Obesity: Analyzing National Data.

The purpose of this study is to understand the factors affecting abdominal obesity. A secondary data analysis was conducted to analyze 5262 individuals' data from the 2020 Korea National Health and Nutrition Examination Survey. The prevalence of obesity was slightly higher in men than women, while abdominal obesity was more prevalent in women. A higher correlation with obesity was observed in young and middle-aged individuals, unmarried individuals, urban residents, those with good subjective health, low-stress perception, moderate alcohol consumption, nonsmokers, regular aerobic exercisers, and those getting more than seven hours of sleep. In contrast, middle-aged and elderly individuals, married individuals, rural residents, those with an elementary school or lower education level, those with low-to-moderate income, those with fair or poor subjective health, high stress perception, nondrinkers, smokers, nonregular aerobic exercisers, and those getting less than seven hours of sleep had a higher correlation with abdominal obesity. Health education suggests that everyone should maintain healthy lifestyle habits, such as getting sufficient sleep, exercise, smoking cessation, and moderate drinking. Specifically, diverse health management support focusing on population groups with demographic factors related to the risk of obesity and abdominal obesity is necessary.

Seeding recurrence of follicular thyroid carcinoma after transoral endoscopic thyroidectomy vestibular approach: a case report.

Background: While track recurrence of thyroid cancer following endoscopic and robotic transaxillary surgeries has been reported previously, no such cases have been reported for transoral endoscopic thyroidectomy vestibular approach (TOETVA). This case report describes the first documented case of recurrence of thyroid cancer along the surgical track after TOETVA. Case Description: The patient underwent right lobectomy via TOETVA for a 4 cm follicular thyroid carcinoma (FTC) initially diagnosed as benign follicular nodule on preoperative gun biopsy. The thyroid capsule partially ruptured within the surgical field during surgery. Ultrasonography and computed tomography conducted 27 months after surgery revealed seeding recurrence in the postsurgical thyroid bed, and subcutaneous layers of the right lower lip, submental area, and mid to right upper neck levels I, IIA, and VI. Two-stage re-operation was done to perform completion thyroidectomy, lymph node dissection, and excision of recurrent nodules, which were pathologically confirmed as metastatic FTC. The patient underwent two treatments of radioactive iodine therapy, and post-therapeutic whole-body scintigraphy and computed tomography showed no residual disease. Conclusions: Careful monitoring after TOETVA is essential due to the rare but potential risk of seeding recurrence, especially when the thyroid gland ruptures during surgery. Surgeons should be aware of this atypical complication and be prepared to recommend surgical and/or medical strategies to manage any local seeding of thyroid tissue that may occur.

Multiomics Analyses Identify AKR1A1 as a Biomarker for Diabetic Kidney Disease.

Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease. Because many genes associate with DKD, multiomics approaches were used to narrow the list of functional genes, gene products, and related pathways providing insights into the pathophysiological mechanisms of DKD. The Kidney Precision Medicine Project human kidney single-cell RNA-sequencing (scRNA-seq) data set and Mendeley Data on human kidney cortex biopsy proteomics were used. The R package Seurat was used to analyze scRNA-seq data and data from a subset of proximal tubule cells. PathfindR was applied for pathway analysis in cell type-specific differentially expressed genes and the R limma package was used to analyze differential protein expression in kidney cortex. A total of 790 differentially expressed genes were identified in proximal tubule cells, including 530 upregulated and 260 downregulated transcripts. Compared with differentially expressed proteins, 24 genes or proteins were in common. An integrated analysis combining protein quantitative trait loci, genome-wide association study hits (namely, estimated glomerular filtration rate), and a plasma metabolomics analysis was performed using baseline metabolites predictive of DKD progression in our longitudinal Diabetes Heart Study samples. The aldo-keto reductase family 1 member A1 gene (AKR1A1) was revealed as a potential molecular hub for DKD cellular dysfunction in several cross-linked pathways featured by deficiency of this enzyme.

Clinicopathological implications of immunohistochemical expression of TBX21, CXCR3, GATA3, CCR4, and TCF1 in nodal follicular helper T-cell lymphoma and peripheral T-cell lymphoma, not otherwise specified.

BACKGROUND: The classification of nodal peripheral T-cell lymphoma (PTCL) has evolved according to histology, cell-of-origin, and genetic alterations. However, the comprehensive expression pattern of follicular helper T-cell (Tfh) markers, T-cell factor-1 (TCF1), and Th1- and Th2-like molecules in nodal PTCL is unclear. METHODS: Eighty-two cases of nodal PTCL were classified into 53 angioimmunoblastic T-cell lymphomas (AITLs)/nodal T-follicular helper cell lymphoma (nTFHL)-AI, 18 PTCLs-Tfh/nTFHL-not otherwise specified (NOS), and 11 PTCLs-NOS according to the revised 4th/5th World Health Organization classifications. Immunohistochemistry for TCF1, TBX21, CXCR3, GATA3, and CCR4 was performed. RESULTS: TCF1 was highly expressed in up to 68% of patients with nTFHL but also in 44% of patients with PTCL-NOS (p > .05). CXCR3 expression was higher in AITLs than in non-AITLs (p = .035), whereas GATA3 expression was higher in non-AITL than in AITL (p = .007) and in PTCL-Tfh compared to AITL (p = .010). Of the cases, 70% of AITL, 44% of PTCLTfh/ nTFHL-NOS, and 36% of PTCL-NOS were subclassified as the TBX21 subtype; and 15% of AITL, 38% of PTCL-Tfh/nTFHL-NOS, and 36% of PTCL-NOS were subclassified as the GATA3 subtype. The others were an unclassified subtype. CCR4 expression was associated with poor progression-free survival (PFS) in patients with PTCL-Tfh (p < .001) and nTFHL (p = .023). The GATA3 subtype showed poor overall survival in PTCL-NOS compared to TBX21 (p = .046) and tended to be associated with poor PFS in patients with non-AITL (p = .054). CONCLUSIONS: The TBX21 subtype was more prevalent than the GATA3 subtype in AITL. The GATA3 subtype was associated with poor prognosis in patients with non-AITL and PTCL-NOS.

A radiologist's guide to median sternotomy.

Median sternotomy is widely recognised as the primary incision technique in cardiac surgery. This surgical procedure involves dividing the sternum to gain access to the heart and lungs, making it invaluable in correcting congenital heart defects. Furthermore, it is frequently employed in adult patients, particularly during coronary artery bypass graft (CABG) procedures. In this imaging review, we present a comprehensive overview of the pre-procedural assessment and various post-sternotomy complications encountered within our clinical experience at a tertiary cardiothoracic centre. The focus of this review is to outline the imaging features associated with mediastinal adhesions and establish the minimal safe distance between the sternum and common mediastinal structures when considering re-sternotomy. By providing visual examples, we aim to facilitate a better understanding of these key concepts. Moreover, we delve into a detailed discussion of a spectrum of postoperative complications that may arise following median sternotomy including those related to metalwork (sternal wire fracture), bone (sternal dehiscence, non-union and osteomyelitis), and soft tissue (abscess, haematoma).

An ICT-based highly fluorescent isoquinoline scaffold for selective Hg(II) detection in real-water samples: Development of a smart, low-cost RGB-Arduino electronic platform.

Selective detection and quantification of Hg2+ ions is crucial to minimize health and environmental risks. Fluorescent organic small-molecule probes have been expeditiously utilized owing to their unique set of improved properties. However, isoquinoline core has not been extensively explored as a fluorescence platform partly due to synthetic challenges. Herein, a serendipitously discovered synthetic route to access a small yet highly functionalized novel isoquinoline-based probe, IQ is reported. The synthesis is achieved through the in-situ generation of ammonia, followed by intermolecular [5C + 1 N] aza-annulation reaction with a ketendithioacetal-based precursor, P-IQ. IQ displayed excellent recognition ability towards Hg2+ ions in H2O:ACN (99:1, v/v) via ICT-off fluorescent quenching behavior. Comparative FT-IR, 1H/13C NMR, mass spectral studies, and DFT analyses were carried out to validate the suggested mechanisms. Reversible studies confirm the secondary recognition effect of in-situ generated (IQ + Hg2+) complex on cysteine. The binding constant and LOD were estimated to be 3.7 × 104 M-1 and 0.86 µM, respectively. Further, IQ was utilized to evaluate the mercury ion content in real water samples demonstrating its effectiveness in water quality monitoring. The practical utility of IQ was further explored by developing TLC strips, Whatman filter-paper strips, and a low-cost, portable Arduino-based platform. Arduino microcontroller is interfaced with an RGB sensor to detect color changes and quantify mercury concentration w.r.t. RGB values.

Intranasal mRNA Delivery via Customized RNA-Polyplex Nanoparticles Enhancing Gene Expression through Photochemical Mechanisms.

Achieving effective mRNA expression in vivo requires careful selection of an appropriate delivery vehicle and route of administration. Among the various routes of administration, intranasal administration has received considerable attention due to its ability to induce potent immune responses. In this context, we designed a specialized cationic polymer tailored for delivery of mRNA into the nasal cavity. These polymers are designed with varying degrees of substitution in different amine groups to allow for identification of the most suitable amine moiety for effective mRNA delivery. We also incorporated a photosensitizer within the polymer structure that can trigger the generation of reactive oxygen species when exposed to light. The synthesized cationic polymer is complexed with anionic mRNA to form a polyplex. Illuminating these polyplexes with laser light enhances their escape from intracellular endosomes, stimulating mRNA translocation into the cytoplasm, followed by increased mRNA expression at the cellular level. Through intranasal administration to C57BL/6 mice, it was confirmed that these photoactive polyplexes effectively induce mRNA expression and activate immune responses in vivo using photochemical effects. This innovative design of a photoactivated cationic polymer presents a promising and reliable strategy to achieve efficient intranasal mRNA delivery. This approach has potential applications in the development of mRNA-based vaccines for both prophylactic and therapeutic purposes.

Association of immunotoxicological indices with lung cancer biomarkers in poultry, grape, and rose farming workers.

Exposure to occupational hazards like dust, pesticides, diesel emission particles, or physical hazards in the agricultural sector is known to cause adverse health effects on farm workers. Our study aimed at addressing the association of immunomodulatory status with plasma levels of lung cancer biomarkers in farming population, attempting to recognition of vulnerable farming group. Blood samples from apparently healthy 51 chicken husbandry, 19 grape orchard, and 21 rose greenhouse workers were subjected to evaluate plasma levels of two representative lung cancer biomarkers, pro-gastrin releasing peptide (Pro-GRP) and cytokeratin fragment 19 (CYFRA 21-1). Peripheral blood mononuclear cells obtained from farmers were used for natural killer (NK) cell phenotyping and cytokines (interferon-gamma, IFN-γ and interleukin-13, IL-13) profiling in the culture supernatant. Compared to the rose greenhouse farmers, the grape orchard and chicken husbandry workers revealed a significantly upregulated plasma Pro-GRP and CYFRA 21-1 level. A low proportion of NK cells was observed among the female grape orchard workers and a lowered IFN- γ:IL-13 ratio was seen in the grape and chicken husbandry workers than the rose workers. Our findings imply that grape orchard and chicken husbandry workers have more disturbed immune homeostasis implicated with augmentation in the levels of lung cancer biomarkers than the rose greenhouse workers.

First Observation of Cyclotron Radiation from MeV-Scale e

We present an apparatus for detection of cyclotron radiation yielding a frequency-based ß^{±} kinetic energy determination in the 5 keV to 2.1 MeV range, characteristic of nuclear ß decays. The cyclotron frequency of the radiating ß particles in a magnetic field is used to determine the ß energy precisely. Our work establishes the foundation to apply the cyclotron radiation emission spectroscopy (CRES) technique, developed by the Project 8 Collaboration, far beyond the 18-keV tritium endpoint region. We report initial measurements of ß^{-}'s from ^{6}He and ß^{+}'s from ^{19}Ne decays to demonstrate the broadband response of our detection system and assess potential systematic uncertainties for ß spectroscopy over the full (MeV) energy range. To our knowledge, this is the first direct observation of cyclotron radiation from individual highly relativistic ß's in a waveguide. This work establishes the application of CRES to a variety of nuclei, opening its reach to searches for new physics beyond the TeV scale via precision ß-decay measurements.

Vutrisiran: A Review in Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis.

Silencing the transthyretin (TTR) gene is an effective strategy in the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis. Vutrisiran (Amvuttra®), an RNA interference (RNAi) therapeutic targeting TTR mRNA, is approved in the USA and EU for the treatment of adults with polyneuropathy of hATTR amyloidosis. N-acetylgalactosamine conjugation and enhanced stabilisation chemistry are utilised to target vutrisiran to the liver and increase stability, respectively, allowing for subcutaneous administration once every 3 months. In a pivotal phase 3 study in patients with hATTR amyloidosis with polyneuropathy, subcutaneous vutrisiran 25 mg every 3 months significantly reduced neuropathy impairment versus external placebo. Vutrisiran was also associated with significant improvements in neuropathy-specific quality of life, gait speed, nutritional status and disability scores. Vutrisiran was generally well tolerated; the only common adverse events to occur at a greater incidence than with external placebo were pain in extremity and arthralgia. Vutrisiran reduces serum vitamin A levels and vitamin A supplementation is recommended. In conclusion, vutrisiran is an efficacious and generally well-tolerated alternative option for the treatment of polyneuropathy of hATTR amyloidosis, which has the potential advantage of infrequent subcutaneous dosage.

Hereditary transthyretin-mediated (hATTR) amyloidosis is a progressive and disabling disease caused by variants in the transthyretin (TTR) gene, which cause destabilisation and misfolding of the TTR protein. Deposition of misfolded TTR protein (amyloid) around nerves causes a range of neuropathic symptoms. Vutrisiran (Amvuttra^®) silences the TTR gene via RNA interference (RNAi). Vutrisiran, administered subcutaneously once every 3 months, is approved in the USA and EU for the treatment of polyneuropathy of hATTR amyloidosis in adults. In a phase 3 study in patients with hATTR amyloidosis with polyneuropathy, vutrisiran significantly reduced neuropathy impairment and improved other disease-related outcomes versus external placebo. Vutrisiran was generally well tolerated, with most adverse events being mild or moderate in severity. As vutrisiran decreases vitamin A levels, patients undergoing vutrisiran treatment should supplement with vitamin A. In conclusion, vutrisiran is an efficacious and generally well-tolerated alternative option for the treatment of polyneuropathy of hATTR amyloidosis, with a convenient dosage regimen.

Perivascular wall tumour presenting as pastern mass in a Standardbred gelding.

A 2-year-old Standardbred gelding was referred for a mass on the palmaromedial right front pastern which was accompanied by progressively worsening lameness. The mass was firm to palpation and covered by normal skin. Ultrasonographically, a smooth encapsulated mass was present, medial to the flexor tendons and palmar to the neurovascular bundle. Because of a poor prognosis for future athletic performance without surgical or chemotherapeutic intervention and economic constraints preventing further diagnostics and treatment, the horse was euthanised. Post-mortem magnetic resonance imaging, histopathology and immunohistochemistry revealed the mass to be a perivascular wall tumour, the first record of such a neoplasia in the horse.

Factors associated with Pap test screening among South Korean women aged 20 to 39 years.

The number of hospital visits with cervical cancer as the chief complaint among South Korean women aged 20 to 39 has increased by 1.2 times between 2016 and 2020, indicating a need for active screening for the disease. This study aimed to investigate the status of the Papanicolaou (Pap) test and identify factors influencing Pap test experience among South Korean women aged 20 to 39 years. An online questionnaire survey was conducted over 5 days starting from November 19, 2021. A total of 338 participants who were randomly sampled by age completed the survey. Data were analyzed using descriptive statistics, t test, χ2 test, and logistic regression. The mean age of the participants was 29.9 years, and participants with and without Pap test experience accounted for 60.7% and 39.3% of the total, respectively. There were significant differences in age, marital status, employment status, smoking status, experience of coitus, awareness of the National Cancer Screening Program, and human papillomavirus (HPV) vaccination status according to the Pap test experience (P < .05) of the participants. Pap test attitude, Pap test self-efficacy, cervical cancer knowledge, HPV knowledge, and cancer prevention behavior scores were significantly higher in the Pap test experience group than in the no Pap test experience group (P < .05). Logistic regression analysis showed that experience of coitus (odds ratio [OR] = 10.46, 95% confidence interval [CI]: 4.54-24.11), marital status (OR = 5.96, 95% CI: 2.25-15.77), awareness of the National Cancer Screening Program (OR = 4.39, 95% CI: 1.66-11.58), HPV vaccination (OR = 2.62, 95% CI: 1.35-5.09), employment status (OR = 2.22, 95% CI: 1.08-4.59), and self-efficacy (OR = 1.09, 95% CI: 1.01-1.19) were the influencing factors in the Pap test experience group. To improve the Pap test screening rate among South Korean women aged 20 to 39, reinforcement strategies and intervention programs that involve age-specific approaches must be established.

Flotufolastat F 18: Diagnostic First Approval.

Flotufolastat F 18 (POSLUMA®) is an 18F-labelled radiohybrid (rh) prostate-specific membrane antigen (PSMA)-targeted imaging agent being developed by Blue Earth Diagnostics, a subsidiary of Bracco Imaging, for prostate cancer imaging. In May 2023, flotufolastat F 18 received its first approval in the USA as a radioactive diagnostic agent for positron emission tomography (PET) of PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. This article summarizes the milestones in the development of flotufolastat F 18 leading to this first approval.

Omidubicel: First Approval.

Omidubicel (omidubicel-onlv; Omisirge®) is a nicotinamide-modified stem cell graft derived from cord blood that is being developed by Gamida Cell for the treatment of haematological malignancies and haemoglobinopathies. In April 2023, omidubicel received its first approval in the USA for use in adults and children aged ≥ 12 years with haematological malignancies who are planned for cord blood transplantation following myeloablative conditioning to reduce the incidence of infection and the time to neutrophil recovery. This article summarizes the milestones in the development of omidubicel leading to this first approval.