Human neural stem cell transplantation in ALS: initial results from a phase I trial

We report the initial results from a phase I clinical trial for ALS. We transplanted GMP-grade, fetal human neural stem cells from natural in utero death (hNSCs) into the anterior horns of the spinal cord to test for the safety of both cells and neurosurgical procedures in these patients. The trial was approved by the Istituto Superiore di Sanit\ue0 and the competent Ethics Committees and was monitored by an external Safety Board

How the First Year of the COVID-19 Pandemic Impacted Patients’ Hospital Admission and Care in the Vascular Surgery Divisions of the Southern Regions of the Italian Peninsula

Background: To investigate the effects of the COVID-19 lockdowns on the vasculopathic population. Methods: The Divisions of Vascular Surgery of the southern Italian peninsula joined this multicenter retrospective study. Each received a 13-point questionnaire investigating the hospitalization rate of vascular patients in the first 11 months of the COVID-19 pandemic and in the preceding 11 months. Results: 27 out of 29 Centers were enrolled. April-December 2020 (7092 patients) vs. 2019 (9161 patients): post-EVAR surveillance, hospitalization for Rutherford category 3 peripheral arterial disease, and asymptomatic carotid stenosis revascularization significantly decreased (1484 (16.2%) vs. 1014 (14.3%), p = 0.0009; 1401 (15.29%) vs. 959 (13.52%), p = 0.0006; and 1558 (17.01%) vs. 934 (13.17%), p < 0.0001, respectively), while admissions for revascularization or major amputations for chronic limb-threatening ischemia and urgent revascularization for symptomatic carotid stenosis significantly increased (1204 (16.98%) vs. 1245 (13.59%), p < 0.0001; 355 (5.01%) vs. 358 (3.91%), p = 0.0007; and 153 (2.16%) vs. 140 (1.53%), p = 0.0009, respectively). Conclusions: The suspension of elective procedures during the COVID-19 pandemic caused a significant reduction in post-EVAR surveillance, and in the hospitalization of asymptomatic carotid stenosis revascularization and Rutherford 3 peripheral arterial disease. Consequentially, we observed a significant increase in admissions for urgent revascularization for symptomatic carotid stenosis, as well as for revascularization or major amputations for chronic limb-threatening ischemia

Are You Telling Me the Truth? Authenticity of Responses in Virtual Worlds Research

Basing on social response theory of consumer behavior, which predicts that the use of social cues in human-computer interaction elicits more sincere responses (Moon 2000; Moon 2003), and recognizing that the social dimension is dominant in virtual worlds’ interactions, we hypothesize that virtual worlds are externally valid contexts for marketing research. We test our hypothesis comparing answers provided in a virtual world context to answers provided in a real context on two heuristics: evaluation and choice. Evidence obtained from two studies supports the external validity of virtual world setting for marketing research both when participants are asked to perform an evaluation and when participants are asked to make a choice

An uncommon case of arterial aneurysms association with high serum levels of plasma levels of Matrix Metalloproteinase-9 and Neutrophil Gelatinase-Associated Lipocalin

The association of an axillary artery aneurysm and an abdominal aortic aneurysm is extremely rare. In this study, we describe this association in a 69 year-old-man. We measured this patient's metalloproteinases (MMPs) and Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels over a three years period before the abdominal aortic aneurysm rupture. We speculate that high serium levels of MMPs and NGAL may have a prognostic role and may predict aneurysm rupture in patients with an uncommon association of arterial aneurysms

An uncommon case of arterial aneurysms association with high plasma levels of Matrix Metalloproteinase-9 and Neutrophil Gelatinase-Associated Lipocalin

The association of an axillary artery aneurysm and an abdominal aortic aneurysm is extremely rare. In this study, we describe this association in a 69 year-old-man. We measured this patient’s metalloproteinases (MMPs) and Neutrophil Gelatinase - Associated Lipocalin (NGAL) levels over a three years period before the abdominal aortic aneurysm rupture. We speculate that high serium levels of MMPs and NGAL may have a prognostic role and may predict aneurysm rupture in patients with an uncommon association of arterial aneurysms

Good clinical response, remission, and predictors of remission in rheumatoid arthritis patients treated with tumor necrosis factor-alpha blockers: The GISEA study

none28OBJECTIVE: To assess the prevalence of good clinical response and remission in rheumatoid arthritis (RA) patients with longstanding disease treated with anti-tumor necrosis factor-alpha (TNF-alpha) drugs at outpatient clinics. METHODS: Retrospective national study of 14 academic tertiary referral rheumatology medical centers. RA patients with a Disease Activity Score (DAS28) > 3.2 were defined as having active disease and could start TNF-alpha blockers. All patients received one TNF-alpha blocker plus methotrexate (10-20 mg/wk). At the third month the patients were categorized as responders or nonresponders, based on improvement of at least 0.25 of the Health Assessment Questionnaire (HAQ). Those who had improved by at least 0.25 HAQ were analyzed for possible predictors of DAS28 remission at the sixth month. RESULTS: A total of 1257 patients started TNF-alpha blockers. Of these, 591 (46.7\%) reached the sixth month with an improvement of HAQ of 0.25 at the third month. In the cohort of patients reaching HAQ of 0.25, DAS28 remission was seen in 24\% of rheumatoid factor (RF)-positive and 36\% of RF-negative patients (p = 0.03). Logistic regression analysis for predictors of remission identified age at baseline, HAQ < 1.63, and RF negativity as positive predictors of remission at 6 months along with sex (male). CONCLUSION: We show that only a minority of patients with longstanding RA achieve a good clinical response or remission at the outpatient community level. Predictors of remission identify characteristics commonly observed in subsets with less severe RA.noneLuana Mancarella; Francesca Bobbio-Pallavicini; Fulvia Ceccarelli; Paola Chiara Falappone; Angelo Ferrante; Domenico Malesci; Alfonso Massara; Francesca Nacci; Maria Elena Secchi; Stefania Manganelli; Fausto Salaffi; Maria Lisa Bambara; Stefano Bombardieri; Maurizio Cutolo; Clodoveo Ferri; Mauro Galeazzi; Roberto Gerli; Roberto Giacomelli; Walter Grassi; Giovanni Lapadula; Marco Matucci Cerinic; Carlomaurizio Montecucco; Francesco Trotta; Giovanni Triolo; Gabriele Valentini; Guido Valesini; Gianfranco F Ferraccioli; G. I. S.Luana, Mancarella; Francesca Bobbio, Pallavicini; Fulvia, Ceccarelli; Paola Chiara, Falappone; Angelo, Ferrante; Domenico, Malesci; Massara, Alfonso; Francesca, Nacci; Maria Elena, Secchi; Stefania, Manganelli; Fausto, Salaffi; Maria Lisa, Bambara; Stefano, Bombardieri; Maurizio, Cutolo; Clodoveo, Ferri; Mauro, Galeazzi; Roberto, Gerli; Roberto, Giacomelli; Walter, Grassi; Giovanni, Lapadula; Marco Matucci, Cerinic; Carlomaurizio, Montecucco; Trotta, Francesco; Giovanni, Triolo; Gabriele, Valentini; Guido, Valesini; Gianfranco F., Ferraccioli; G. I., S

Good clinical response, remission, and predictors of remission in rheumatoid arthritis patients treated with tumor necrosis factor-alpha blockers: the GISEA study.

OBJECTIVE: To assess the prevalence of good clinical response and remission in rheumatoid arthritis (RA) patients with longstanding disease treated with anti-tumor necrosis factor-alpha (TNF-alpha) drugs at outpatient clinics. METHODS: Retrospective national study of 14 academic tertiary referral rheumatology medical centers. RA patients with a Disease Activity Score (DAS28) > 3.2 were defined as having active disease and could start TNF-alpha blockers. All patients received one TNF-alpha blocker plus methotrexate (10-20 mg/wk). At the third month the patients were categorized as responders or nonresponders, based on improvement of at least 0.25 of the Health Assessment Questionnaire (HAQ). Those who had improved by at least 0.25 HAQ were analyzed for possible predictors of DAS28 remission at the sixth month. RESULTS: A total of 1257 patients started TNF-alpha blockers. Of these, 591 (46.7\%) reached the sixth month with an improvement of HAQ of 0.25 at the third month. In the cohort of patients reaching HAQ of 0.25, DAS28 remission was seen in 24\% of rheumatoid factor (RF)-positive and 36\% of RF-negative patients (p = 0.03). Logistic regression analysis for predictors of remission identified age at baseline, HAQ < 1.63, and RF negativity as positive predictors of remission at 6 months along with sex (male). CONCLUSION: We show that only a minority of patients with longstanding RA achieve a good clinical response or remission at the outpatient community level. Predictors of remission identify characteristics commonly observed in subsets with less severe RA

Sex-Related Differences and Factors Associated with Peri-Procedural and 1 Year Mortality in Chronic Limb-Threatening Ischemia Patients from the CLIMATE Italian Registry

Background: Identifying sex-related differences/variables associated with 30 day/1 year mortality in patients with chronic limb-threatening ischemia (CLTI). Methods: Multicenter/retrospective/observational study. A database was sent to all the Italian vascular surgeries to collect all the patients operated on for CLTI in 2019. Acute lower-limb ischemia and neuropathic-diabetic foot are not included. Follow-up: One year. Data on demographics/comorbidities, treatments/outcomes, and 30 day/1 year mortality were investigated. Results: Information on 2399 cases (69.8% men) from 36/143 (25.2%) centers. Median (IQR) age: 73 (66-80) and 79 (71-85) years for men/women, respectively (p &lt; 0.0001). Women were more likely to be over 75 (63.2% vs. 40.1%, p = 0.0001). More men smokers (73.7% vs. 42.2%, p &lt; 0.0001), are on hemodialysis (10.1% vs. 6.7%, p = 0.006), affected by diabetes (61.9% vs. 52.8%, p &lt; 0.0001), dyslipidemia (69.3% vs. 61.3%, p &lt; 0.0001), hypertension (91.8% vs. 88.5%, p = 0.011), coronaropathy (43.9% vs. 29.4%, p &lt; 0.0001), bronchopneumopathy (37.1% vs. 25.6%, p &lt; 0.0001), underwent more open/hybrid surgeries (37.9% vs. 28.8%, p &lt; 0.0001), and minor amputations (22% vs. 13.7%, p &lt; 0.0001). More women underwent endovascular revascularizations (61.6% vs. 55.2%, p = 0.004), major amputations (9.6% vs. 6.9%, p = 0.024), and obtained limb-salvage if with limited gangrene (50.8% vs. 44.9%, p = 0.017). Age &gt; 75 (HR = 3.63, p = 0.003) is associated with 30 day mortality. Age &gt; 75 (HR = 2.14, p &lt; 0.0001), nephropathy (HR = 1.54, p &lt; 0.0001), coronaropathy (HR = 1.26, p = 0.036), and infection/necrosis of the foot (dry, HR = 1.42, p = 0.040; wet, HR = 2.04, p &lt; 0.0001) are associated with 1 year mortality. No sex-linked difference in mortality statistics. Conclusion: Women exhibit fewer comorbidities but are struck by CLTI when over 75, a factor associated with short- and mid-term mortality, explaining why mortality does not statistically differ between the sexes

Secondary endovascular procedures improve overall patency and limb salvage in patients undergoing in situ saphenous vein infragenicular bypass

BACKGROUND: Secondary interventions strongly improves patency and limb salvage rates in patients undergoing infrainguinal vein bypass. The aim of this study was to evaluate the influence of secondary endovascular procedures performed during the follow-up on patency and limb salvage in patients with critical limb-threatening ischemia (CLTI) undergoing in situ saphenous vein infragenicular bypass. METHODS: From January 2018 to December 2019 541 patients in 43 centers have been enrolled into the LIMBSAVE registry (treatment of critical Limb IschaeMia with infragenicular Bypass adopting in situ SAphenous VEin technique). In all patients a strict surveillance program with Duplex scan was established (1, 3, 6, 9, 12, 18, 24 months). During the follow-up indications for endovascular procedures were anastomotic stenoses, improvement of run-in (iliac stenosis) or run-off (tibial vessels' stenoses or occlusions). Two-year estimated outcomes in terms of overall patency, and limb salvage were analyzed by life-table analysis (Kaplan-Meier test). Outcomes obtained in patients undergoing endovascular procedure (Group-endo) were compared by means of Gehan-Breslow-Wilcoxon Test with those obtained in patients with no secondary RESULTS: Two groups were homogeneous in terms of demographics and intraprocedural details. Overall mean duration of follow-up was 12.1 months (range 1-24). During the follow-up period (&gt;30 days) 55 endovascular procedures were performed in 49 patients (9.1%) (Group-endo). Most of endovascular procedures (37/55, 67.3%) was performed to treat stenoses at proximal or distal anastomosis. Secondary endovascular procedures (40/55, 72.7%) were predominantly performed within 6 months from the index procedure. Estimated 2-year overall patency (97.9% vs. 85.2%, P=0.05), and limb salvage (100% vs. 93.9%, P=0.05) rates were significantly better in Group-endo. CONCLUSIONS: Secondary endovascular procedures in patients with CLTI undergoing in situ saphenous infragenicular bypass significantly improve the rates of overall patency and limb salvage in the mid-term period. improve overall patency and limb salvage in patients undergoing in situ saphenous vein infragenicular bypass. J Cardiovasc Surg 2023;64:430-6. DOI