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Cesaro S.,Pediatric Hematology Oncology | Tridello G.,Pediatric Hematology Oncology | Prete A.,Pediatric Hematology Oncology | Dallorso S.,Pediatric Hematology Oncology | And 5 more authors.
Transfusion | Year: 2015

Background: Recently biosimilars of granulocyte-colony-stimulating factor (G-CSF) became available for prophylaxis and treatment of postchemotherapy neutropenia and for mobilization of peripheral blood CD34+ cells for either autologous or allogeneic hematopoietic stem cell transplant. Most of the data on the mobilization efficacy and safety of biosimilar G-CSF are from adult patients, whereas no data are available in pediatric patients. Study Design and Methods: This was a retrospective study on cases treated at three Italian pediatric transplant centers, from January 2011 to October 2013. Data were collected on all children undergoing first peripheral blood stem cell (PBSC) mobilization after stimulation with biosimilar G-CSF and chemotherapy. The results were compared with a historical control group. Results: Twenty-nine children underwent mobilization with biosimilar G-CSF. Peak peripheral blood CD34+ cell count of 20 × 106/L was achieved in 90% of patients, with a median value of 71 × 106/L. Eighty-three percent reached the desired target (CD34+/kg) dose. The median number of collected CD34+ cells was 10 × 106/kg (range, 4.8 × 106-68.8 × 106/kg). No difference was observed in comparison with historical control group mobilized with originator filgrastim. Moreover, no major and/or unexpected side effects were reported. Conclusion: Biosimilar G-CSF resulted as effective and safe as originator filgrastim molecule in mobilizing PBSCs in children, with the advantage of a reduced cost. © 2014 AABB.

Zanconato G.,University of Verona | Cavaliere E.,University of Verona | Iacovella C.,University of Verona | Vassanelli A.,Immunohematology and Transfusion Service | And 3 more authors.
Journal of Maternal-Fetal and Neonatal Medicine | Year: 2012

Objective: To assess prevalence and causes of severe acute maternal morbidity cases and evaluate their impact on feto-maternal wellbeing and on facility resources. Study Design: Observational retrospective study adopting management-based criteria in a tertiary care public hospital during a 5-year period. Criteria adopted were: intensive care unit admission, blood transfusion≥ 4 units, emergency peripartum hysterectomy and arterial embolization at any time during pregnancy. Results: A total of 80 cases were identified, most of them (97.5%) through a combination of two criteria, ICU admission and blood transfusion. Commonest severe obstetric morbidities were major obstetric haemorrhage (48.8%) and hypertensive disorders (27.5%). Immigrant status (OR 1.68, 95% CI 1.032.7), pre-term birth (OR 4.15, 95% CI 2.56.8), Caesarean section (OR 7.74,95% CI 4.214.3) were factors significantly associated with SAMM cases. Major abdominal surgery was necessary in 26 women (32.5%), with emergency peripartum hysterectomy in 11 (13.5%). These events led to an average blood consumption per woman of 6.5±12.8 units and a mean hospital stay of 8.9±5.0 days, significantly longer (p<0.001) than the average duration of post-delivery care. Maternal mortality to morbility ratio was 1:80. Conclusions: An integrated intervention-based approach proved to be effective in finding severe acute maternal morbidity cases. Information on underlying causes and associated risk factors may improve prevention and treatment of obstetric morbidities, thus reducing feto-maternal adverse effects and hospital expenditures. © 2012 Informa UK, Ltd.

Soria A.,University of Milan Bicocca | Guerini F.R.,Foundation Medicine | Bandera A.,University of Milan Bicocca | Bolognesi E.,Foundation Medicine | And 8 more authors.
PLoS ONE | Year: 2011

Background: In HIV-infected individuals, mechanisms underlying unsatisfactory immune recovery during effective combination antiretroviral therapy (cART) have yet to be fully understood. We investigated whether polymorphism of genes encoding immune-regulating molecules, such as killer immunoglobulin-like receptors (KIR) and their ligands class I human leukocyte antigen (HLA), could influence immunological response to cART. Methods: KIR and HLA frequencies were analyzed in 154 HIV-infected and cART-treated patients with undetectable viral load divided into two groups: 'immunological non responders' (INR, N = 50, CD4 + T-cell count <200/mm 3) and full responders (FR, N = 104, CD4 + T-cell count >350/mm 3). Molecular KIR were typed using polymerase chain reaction-based genotyping. Comparisons were adjusted for baseline patient characteristics. Results: The frequency of KIR2DL3 allele was significantly higher in FR than in INR (83.7% vs. 62%, P = 0.005). The functional compound genotype HLA-C1 +/KIR2DL3 +, even at multivariable analysis, when adjusted for nadir CD4 + T-cell count, was associated with reduced risk of INR status: odds ratio (95% Confidence Intervals) 0.34 (0.13-0.88), P = 0.03. Conclusions: Reduced presence of the inhibitory KIR2DL3 genotype detected in INR might provoke an imbalance in NK function, possibly leading to increased immune activation, impaired killing of latently infected cells, and higher proviral burden. These factors would hinder full immune recovery during therapy. © 2011 Soria et al.

Sambataro M.,Metabolism Disease and Clinical Nutrition Unit | Seganfreddo E.,Metabolism Disease and Clinical Nutrition Unit | Canal F.,Santa Maria di Ca Foncello Hospital | Furlan A.,Hematology Unit | And 5 more authors.
International Journal of Vascular Medicine | Year: 2014

Objective. We studied circulating precursor cells (CPC) in type 2 diabetes mellitus (T2DM) with neuropathic foot lesions with or without critical limb ischemia and relationships between endothelial precursor cells (EPC) and peripheral neuropathy. Methods and Subjects. We measured peripheral blood CD34, CD133, and CD45 markers for CPC and KDR, CD31 markers for EPC by citofluorimetry and systemic neural nociceptor CGRP (calcitonin gene related protein) by ELISA in 8 healthy controls (C) and 62 T2DM patients: 14 with neuropathy (N), 20 with neuropathic foot lesions (N1), and 28 with neuroischemic recent revascularized (N2) foot lesions. Timing of lesions was: acute (until 6 weeks), healed, and not healed. Results. CD34+ and CD133+ were reduced in N, N1, and N2 versus C, and CD34+ were lower in N2 versus N1 (P=0.03). In N2 CD34+KDR+ remain elevated in healed versus chronic lesions and, in N1 CD133+31+ were elevated in acute lesions. CGRP was reduced in N2 and N1 versus C (P<0.04 versus C 26±2 pg/mL). CD34+KDR+ correlated in N2 with oximetry and negatively in N1 with CGRP. Conclusions. CD34+ CPC are reduced in diabetes with advanced complications and diabetic foot. CD34+KDR+ and CD31+133+ EPC differentiation could have a prognostic and therapeutic significance in the healing process of neuropathic and neuroischemic lesions. © 2014 Maria Sambataro et al.

Rattazzi M.,University of Padua | Villalta S.,Medicina Interna I | Galliazzo S.,Medicina Interna I | Del Pup L.,Immunohematology and Transfusion Service | And 12 more authors.
Clinical Science | Year: 2013

The relationship between MetS (metabolic syndrome), levels of circulating progenitor/immune cells and the risk of VTE (venous thromboembolism) has not yet been investigated. We studied 240 patients with previous VTE and 240 controls. The presence of MetS was identified according to NCEP ATP III guidelines and flow cytometry was used to quantify circulating CD34+ cells. VTE patients showed higher BMI (body mass index), waist circumference, triacylglycerol (triglyceride) levels, blood glucose, hs-CRP (high-sensitivity C-reactive protein) and lower HDL-C (high-density lipoprotein cholesterol) levels. The prevalence of MetS was significantly higher in VTE (38.3%) than in control individuals (21.3%) with an adjusted OR (odds ratio) for VTE of 1.96 (P=0.002). VTE patients had higher circulating neutrophils (P<0.0001), while the CD34+ cell count was significantly lower among patients with unprovoked VTE compared with both provoked VTE (P=0.004) and controls (P=0.003). Subjects were also grouped according to the presence/absence of MetS (MetS+ or MetS- ) and the level (high/low) of both CD34+ cells and neutrophils. Very high adjusted ORs for VTE were observed among neutrophils_high/MetS+ (OR, 3.58; P<0.0001) and CD34+ _low/MetS+ (OR, 3.98; P<0.0001) subjects as compared with the neutrophils_low/MetS- and CD34+ _high/MetS- groups respectively. In conclusion, low CD34+ blood cell count and high circulating neutrophils interplay with MetS in raising the risk for venous thromboembolic events. © The Authors Journal compilation 2013 Biochemical Society.

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