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This article examines the economic performance of a certified laboratory that specializes in cell manipulation in a public health setting. The laboratory follows international standards for transplantation and related therapies to ensure high quality and patient safety. However, there are challenges in determining reimbursements for the costs associated with these standards. The authors analyze the laboratory's costs and incomes and find that it is experiencing a significant economic loss. To address this issue, the authors propose implementing charges for activities that are not economically recognized. Additionally, the article discusses the economic aspects of processing and storing autologous hematopoietic stem cell collections for transplantation. The current policies of disposing of unused products and the lack of specific reimbursement for long-term storage make processing laboratories financially unsustainable. The authors suggest that the affordability of cell therapies should be assessed using dedicated modeling strategies. [Extracted from the article]

Therapeutic apheresis (TA) includes a wide range of therapeutic procedures based on the separation of blood components and the collection of cells with therapeutic activity or the removal of unwanted plasma or cellular components involved in the etiology of various hematologic, renal, neurological, and medical diseases. The complexity of these interventions requires an organizing model to assure a proper clinical environment, technology, quality requirements, and personnel as well as an active system for outcome monitoring for safety and efficacy. Finally, a structured organizing model may favor the efficiency of the TA unit and economic affordability. Here, we describe the more relevant characteristics of a model of TA standards, named TA unit (TAU) standards, that may help to establish a quality program in units working in the field of TA (shown as supplementary material and available at http://www.ifeit.org/pdf/TAU_Standards_3.0.pdf. [ABSTRACT FROM AUTHOR]

Between September 15 and November 11, 2017, the area of Rome was subjected to cessation of donation in an area of approximately 1,300,000 inhabitants and with a 5-day quarantine for the rest of metropolitan areas due to Chikungunya virus (CHIKV) outbreak. Quarantine was applied to red blood cell (RBC) and plasma units while platelet concentrates (PCs) were subjected to pathogen inactivation methods (PIMs). Quarantine was based on an active recall of all donors and, in case of declared absence of any symptom or illness, on release of RBC and plasma units after 5 days. Four regional centers in which PIMs were already performed were charged for PIMs for the rest of Rome's area. These centers increased by 236% their previous PIM procedures, producing additional 1425 pathogen-reduced (PR) PCs in 57 days, beside their production (996 PR PCs) for local needs. The emergency support was close to the maximal production capacity of the four centers and was successful only thanks to the limited length of emergency. No adverse events were reported by all centers through a passive hemovigilance approach and by a follow-up of approximately 4 months. None of the donors referred symptoms or illness at recall and none of the blood products were discarded after quarantine. To date, no cases of CHIKV-transmitted infection were reported in transfused patients. This experience has taught some relevant strategic and organizing aspects that should be taken into account when an infectious outbreak must be faced in a large metropolitan area. [ABSTRACT FROM AUTHOR]

Background: Randomized trials comparing chemomobilization efficiency between lenograstim and biosimilar filgrastim are lacking. Our previous retrospective study suggested that lenograstim could be more effective than biosimilar filgrastim when used at the same conventional dosage (5 µg/kg) only in lymphoma patients undergoing peripheral blood stem cell mobilization. We planned a prospective randomized study comparing lenograstim 5 µg/kg with biosimilar filgrastim 10 µg/kg to verify the hypothesis of lenograstim superiority even at half the dosage (stress test). Herein we report data after enrolling 60% of planned patients.Study Design and Methods: From October 2014 to November 2017, a total of 42 of 70 planned patients with lymphoma were randomly assigned to receive lenograstim 5 µg/kg (21) or biosimilar filgrastim 10 µg/kg (21). Patients were stratified according to treatment line at the time of mobilization (1 or ≥2). Primary endpoint was the rate of achievement of the CD34+ cell collection target dose (≥ 4 × 106 /kg). An improvement by 23% was expected to validate the hypothesis of lenograstim superiority.Results: The two cohorts were balanced for all the baseline features. We observed an identical rate of patients able to reach the targeted CD34+ cell dose and of mobilization failures (90.4 and 4.8% in both cohorts) and a perfect equivalence in any of the secondary collection outcomes. The hypothesis of lenograstim superiority was not corroborated at interim analysis.Conclusion: Lenograstim at conventional dosage has failed to demonstrate its superiority over biosimilar filgrastim at double the dosage at interim analysis in their first head-to-head trial. [ABSTRACT FROM AUTHOR]

Harpagophytum procumbens is a plant species that displays anti-inflammatory properties in multiple tissues. The iridoid glycosides arpagoside, harpagide, and procumbide appear to be the most therapeutically important constituents. In addition, harpagoside treatment exerted neuroprotective effects both in vitro and in vivo. Considering these findings, the aim of the present work is to explore the possible protective role of the previously described microwave-assisted aqueous extract of H. procumbens on rat hypothalamic (Hypo-E22) cells, and in rat cortex challenged with amyloid β-peptide (1-40). In this context, we assayed the protective effects induced by H. procumbens by measuring the levels of malondialdehyde, 3-hydroxykynurenine (3-HK), brain-derived neurotrophic factor, and tumor necrosis factor-α, 3-HK. Finally, we evaluated the effects of H. procumbens treatment on cortex levels of dopamine, norepinephrine, and serotonin. H. procumbens extract was well tolerated by Hypo-E22 cells and upregulated brain-derived neurotrophic factor gene expression but down-regulated tumor necrosis factor-α gene expression. In addition, the extract reduced amyloid β-peptide stimulation of malondialdehyde and 3-HK and blunted the decrease of dopamine, norepinephrine, and serotonin, in the cortex. In this context, our work supports further studies for the evaluation and confirmation of Harpagophytum in the management of the clinical symptoms related to Alzheimer's disease. Copyright © 2017 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Harpagophytum procumbens has a long story of use for the treatment of inflammatory diseases. Considering both the antiinflammatory effects of H. procumbens in multiple tissues and the stability of harpagoside in artificial intestinal fluid, the aim of the present study was to explore the possible protective role of a microwave-assisted aqueous Harpagophytum extract (1-1000 μg/mL) on mouse myoblast C2C12 and human colorectal adenocarcinoma HCT116 cell lines, and isolated rat colon specimens challenged with lipopolysaccharide (LPS), a validated ex vivo model of acute ulcerative colitis. In this context, we evaluated the effects on C2C12 and HCT116 viability, and on LPS-induced production of serotonin (5-HT), tumor necrosis factor (TNF)-α, prostaglandin (PG)E2 and 8-iso-prostaglandin (8-iso-PG)F2α . Harpagophytum extract was well tolerated by C2C12 cells, while reduced HCT116 colon cancer cell viability. On the other hand, Harpagophytum extract reduced H2 O2 -induced (1 mM) reactive oxygen species (ROS) production, in both cell lines, and inhibited LPS-induced colon production of PGE2 , 8-iso-PGF2α , 5-HT and TNFα. Concluding, we demonstrated the efficacy of a microwave-assisted Harpagophytum aqueous extract in modulating the inflammatory, oxidative stress and immune response in an experimental model of inflammatory bowel diseases (IBD), thus suggesting a rational use of Harpagophytum in the management and prevention of ulcerative colitis in humans. Copyright © 2017 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Inflammatory bowel diseases (IBDs) are chronic disorders characterized by disruption and ulceration of the colonic mucosa or of any part of the digestive tract (Crohn's disease). Antioxidant/anti-inflammatory herbal extract supplementation could represent an innovative approach to contrast IBDs. Clinical trials demonstrated the efficacy of natural formulas, containing chamomile, in patients with gastrointestinal disorders. This is consistent, albeit in part, with the antioxidant and anti-inflammatory properties of chamomile. The aim of the present study was to explore the possible protective role of a chamomile extract, on human colorectal adenocarcinoma HT29 cell, and rat colon specimens treated with lipopolysaccharide (LPS) to induce an inflammatory stimulus, a well established model of acute ulcerative colitis. In this context, the activities of different biomarkers of inflammation and lipid peroxidation such as ROS, myeloperoxidase (MPO), serotonin (5-HT), prostaglandin (PG)E2 , 8-iso-prostaglandin (8-iso-PG)F2α , NF-kB, tumor necrosis factor (TNF)α and interleukin (IL)-6 were assessed. We found that chamomile extract was as effective as sulfasalazine (2 mg/ml) in reducing the production of MPO, 5-HT, IL-6, NF-kB, TNFα, PGE2 and 8-iso-PGF2α , after inflammatory stimulus. The observed modulatory effects support a rationale use of chamomile supplementation as a promising pharmacological tool for the prevention and management of ulcerative colitis in humans. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Currently little is known as to how nutritionally derived compounds may affect dendritic cell (DC) maturation and potentially prevent inappropriate inflammatory responses that are characteristic of chronic inflammatory syndromes. Previous observations have demonstrated that two polyphenols quercetin and piperine delivered through reconstituted oil bodies (ROBs-QP) can influence DC maturation in response to LPS leading to a modulated inflammatory response. In the present study, we examined the molecular effects of ROBs-QP exposure on DC differentiation in mice and identified a unique molecular signature in response to LPS administration that potentially modulates DC maturation and activity in inflammatory conditions. Following LPS administration, ROBs-QP-exposed DCs expressed an altered molecular profile as compared with control DCs, including cytokine and chemokine production, chemokine receptor repertoire, and antigen presentation ability. In vivo ROBs-QP administration suppresses antigen-specific T-cell division in the draining lymph nodes resulting from a reduced ability to create stable immunological synapse. Our data demonstrate that polyphenols exposure can drive DCs toward a new anti-inflammatory molecular profile capable of dampening the inflammatory response, highlighting their potential as complementary nutritional approaches in the treatment of chronic inflammatory syndromes. [ABSTRACT FROM AUTHOR]

The aim of this retrospective, multicenter study was to compare high- versus standard-dose lenograstim after chemotherapy in collecting target dose of CD34+ peripheral blood progenitor cells (PBPCs) in adult candidates for autologous transplant. A total of 166 consecutive patients (28 acute leukemias [ALs], 77 lymphomas, 61 multiple myeloma [MM]) underwent 182 mobilization procedures. Only the first were analyzed. The CD34+ cell target was at least 2 × 10, 4 × 10, and 8 × 10/kg and lenograstim started on days +19, +1, and +5 from the end of chemotherapy for AL, lymphomas, and MM, respectively. Eighty-seven and 79 patients, respectively, received 5 and 10 µg/kg/day lenograstim subcutaneously (sc). An analysis to evaluate factors predicting satisfactory procedures and outcome of transplants performed with first-mobilization-procedure PBPCs was conducted. Most patients received 6 mg of pegfilgrastim or 5 µg/kg/day lenograstim sc after transplant. In multivariate analysis, high-dose lenograstim (p = 0.053) in MM and male sex (p = 0.028) were positive predictive factors for reaching cell target. Fludarabine negatively influenced stimulation length (p = 0.002). Apheresis, CD34+ cells mobilized and collected, blood volume processed, side effects, transplants performed, and engraftment time were similar between lenograstim cohorts. Pegfilgrastim versus lenograstim delayed platelet (PLT) recovery times (13 days vs. 11 days, p = 0.036). High-dose lenograstim more efficiently mobilized MM patients requiring the highest PBPC target but did not influence transplants performed and engraftment time. Male patients mobilized more efficiently. Fludarabine negatively influenced stimulation length. Finally, pegfilgrastim seems to delay PLT recovery. [ABSTRACT FROM AUTHOR]

Background: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) encompasses a spectrum of histological conditions ranging from simple steatosis to fibrosing steatohepatitis, and is a risk factor for cardiovascular diseases (CVD). While oxidised apolipoproteins A and B have been linked to obesity and CVD, the association between other oxidised apolipoproteins and MASLD is yet to be established. To fill this gap, we characterised the circulating serum peptidome of patients with MASLD., Methods: We studied the serum of 87 biopsy-confirmed MASLD patients and 20 age- and sex-matched control (CTRL) subjects. We first employed an untargeted LC-MS/MS peptidomics approach (9 CTRL, 32 MASLD) to identify key hits differentially modulated, and subsequently validated the most relevant findings through targeted peptidomics in an enlarged study population (87 MASLD and 20 CTRL)., Results: Untargeted serum peptidomics identified several oxidised apolipoprotein peptide fragments, including ApoE and ApoC-III, significantly upregulated in MASLD compared to CTRL. Specifically focusing on the oxidative status of intact ApoC-III, studied through its major glycoforms (ApoC-III 0 , ApoC-III i and ApoC-III ii ), we observed a marked reduction in non-oxidised forms of these circulating peptides alongside substantially increased levels of their oxidised proteoforms in MASLD versus controls (but not within the disease stages). Oxidised ApoE and ApoC-III peptide fragments were also significantly correlated with obesity, insulin resistance, dyslipidaemia and transaminases, suggesting a potential link between circulating apolipoprotein oxidation and systemic/hepatic metabolic dysfunction., Conclusion: Our data reveals a previously unreported oxidised apolipoprotein profile associated with MASLD. The functional and clinical implications of these findings warrant further mechanistic investigation., (© 2025 The Author(s). Liver International published by John Wiley & Sons Ltd.)