West Nile virus: the Italian national transplant network reaction to an alert in the north-eastern region, Italy 2011.

We report four cases of West Nile virus (WNV) transmission following a single multiorgan donation in north-eastern Italy. The transmissions were promptly detected by local transplant centres. The donor had been tested for WNV by nucleic acid amplification test (NAT) prior to transplantation and was negative. There were no detected errors in the nationally implemented WNV safety protocols

The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for <i>Clostridioides difficile</i> Infection in Italy

Faecal microbiota transplantation (FMT) is regarded as an efficacious treatment for recurrent C. difficile infection. Unfortunately, widespread patient access is hindered by regulatory hurdles, which are the primary barriers to incorporating FMT into clinical practice. At the European and International level, there is no uniform perspective on FMT classification, and a coordinated effort is desirable to solve this regulatory puzzle. In this communication, we report the regulatory principles and the implementation approach for FMT application in Italy. Our experience suggests that the EU Tissue and Cell Directives are suited to ensure safe and efficient FMT for C. difficile management, especially through extensive high-quality donor selection and full traceability maintenance

Daunorubicin Impairs 1-Beta-D-Arabinofuranosylcytosine Uptake

Daunorubicin (DNR) and l-β-D-arabinofuranosylcytosine (Ara-C) act in a schedule-dependent fashion on leukemic cells. The present study was undertaken to determine whether the inhibition exerted by DNR on Ara-C cytotoxicity on HL 60 cells could be accounted for by an impairment of its uptake. After 250 ng/ml DNR treatment for 30 min, the time course of Ara-C uptake was measured, up to 128 min of incubation at 37°C and at 4°C, compared with controls. We found that DNR inhibits Ara-C uptake both at 37 and 4°C, mostly acting on passive diffusion

Organ donor screening for carbapenem-resistant gram-negative bacteria in Italian intensive care units: the DRIn study

The 759 cases of brain death declaration (BDD [Italian law, 6&nbsp;hours of observation time]) that occurred in 190 Italian intensive care units (ICUs) between May and September 2012 were studied to quantify carbapenem-resistant gram-negative bacteria (CR-GN) isolated in organ donors, to evaluate adherence to national screening guidelines, and to identify risk factors for CR-GN isolation. Mandatory blood, bronchoalveolar lavage, and urine cultures were performed on the BDD day in 99% of used donors. Because results were rarely made available before transplant, &gt;20% of transplants were performed before obtaining any microbiological information, and organs from 15 of 22 CR-GN cases were used. Two (lung-liver) of the 37 recipients died, likely because of donor-derived early CR-GN sepsis. ICU stay &gt;3&nbsp;days (odds ratio [OR]&nbsp;=&nbsp;7.49, P&nbsp;=&nbsp;.004), fever (OR&nbsp;=&nbsp;3.11, P&nbsp;=&nbsp;.04), age &lt;60&nbsp;years (OR&nbsp;=&nbsp;2.80, P&nbsp;=&nbsp;.06), and positive ICU epidemiology (OR&nbsp;=&nbsp;8.77, P&nbsp;=&nbsp;.07) were associated with CR-GN isolation. An association between single ICU and risk of CR-GN was observed, as a result of differences across ICUs (ICC&nbsp;=&nbsp;29%; 95% confidence interval [CI] 6.5%-72%) probably related to inadequate practices of infection control. Continuous education aimed at implementing priority actions, including stewardship programs for a rational use of antimicrobials, is a priority in healthcare systems and transplant networks. Improved awareness among ICU personnel regarding the importance of early CR-GN detection and timely alert systems might facilitate decisions regarding organ suitability and eventually save recipient lives

A survey on preoperative autologous blood donation policy in bone marrow stem cell donors in Italy

Background: The high safety of homologous blood components, together with the introduction of the Patient Blood Management strategy, has led to the progressive abandonment of preoperative autologous blood donation (PAD) in surgery. Furthermore, recent scientific publications provide evidence about the non-usefulness of PAD in the collection of hematopoietic stem cells (HSC) from bone marrow (BM), also in consideration of harvest procedure safety. Nevertheless, no conclusive studies have been published yet. Materials and methods: Blood Establishments (BE) and Bone Marrow Collection Centers (BMCC) participated in a specific qualitative survey proposed by Italian National Blood and Transplant centers with the support of the relevant Italian Scientific Societies. The survey aimed at evaluating the policy adopted for PAD in related and unrelated adult HSC donors in Italy during the period 2018-2020. Results: Forty-one BE corresponding to 37 BMCC filled in the questionnaire. Of 830 BM donors, 661 (80%) underwent 1063 PAD (mean 1.6 PAD/donor). The remaining 169 donors (20%) underwent BM harvest without PAD. No serious adverse events were reported for either donor group. In the case of ineligibility of donors for the PAD program, due to low hemoglobin values, 7/10 centers shifted donors to peripheral blood stem cell collection and three centers chose a different donor. Remarkably, only 51% of the PAD units requested were eventually transfused during the BM harvest process. Finally, the iron support policy among centers was heterogeneous. Discussion: The results of this survey show that PAD is heterogeneously applied in Italian BMCC, as in other countries. However, all BMCC except two are willing to adopt a Patient Blood Management strategy as an alternative approach to adult related and unrelated BM donor harvests

A policy for the disposal of autologous hematopoietic progenitor cells: report from an Italian consensus panel

Background: Autologous stem cell transplantation (ASCT) requires collection and cryopreservation of hematopoietic progenitor cells (HPCs), which in turn may be partially or never reinfused. Thus, HPC storage has become a logistic, ethical, and economic issue. SIDEM, GITMO, and CNT/ISS endorsed a project aimed to define national criteria for HPC disposal aimed to guarantee appropriateness and equity. Study Design and Methods: A multidisciplinary panel was convened including HPC harvest and manipulation experts from apheresis units, hematologists with clinical expertise in ASCT, a representative of the national health authority, and a bioethicist. An analytic hierarchy process (AHP) was carried out to select disposal criteria. Results: The AHP selected two criteria for prompt disposal of freshly collected HPCs: an abnormal freezing procedure causing highly reduced viability or major microbiology contamination. Moreover, AHP selected six major criteria, each one of them allowing for the disposal of stored HPC units: patient death, withdrawal of consent to ASCT, contraindications or loss of indications to ASCT, a damaged label that prevents correct identification of the unit, and time elapsed since harvest longer than 10 years. Three minor criteria were additionally identified that allowed to anticipate disposal only provided that viability levels are below the limit of acceptance: a documented cold chain interruption, loss of bag integrity, and total amount of stored CD34+ cells lower than 1×106/kg or lower than 2×106/kg in patients with a successfully completed stem cell transplantation program. Conclusions: A formal consensus process allowed SIDEM and GITMO to propose a policy for autologous HPC disposal that fulfills clinical, ethical, and economic criteria. © 2014 AABB

Management of carbapenem resistant Klebsiella pneumoniae infections in stem cell transplant recipients: An italian multidisciplinary consensus statement

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Risk factors of extraneural spreading in astrocytomas and oligodendrogliomas in donors with gliomas: A systematic review

Patients with a history of primary brain tumors can be eligible for organ donation under extended criteria. The risk assessment of tumor transmission via organ transplant in primary brain tumors is primarily based on the assessment of tumor histotype and grade. Previous surgeries, chemo-/radiotherapy, and ventriculo-peritoneal shunt placement can lead to a disruption of the blood-brain barrier, concurring to an increase in the transmission risk