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Abstract Background A novel approach suggested that cognitive and dispositional features may explain in depth the health behaviors adoption and the adherence to prevention programs. The Health Orientation Scale (HOS) has been extensively used to map the adoption of health and unhealthy behaviors according to cognitive and dispositional features. Coherently, the main aim of the current research was to assess the factor structure of the Italian version of the HOS using exploratory and confirmatory factor analysis and testing the construct validity of the scale by assessing differences in health orientations between tobacco cigarette smokers and nonsmokers. Method The research protocol was organized in two studies. Study 1 evaluated the dimensionality of the HOS in a sample of Northern Italian healthy people. Three hundred and twenty-one participants were enrolled; they were 229 women (71.3%) and 92 men (28.7%). In Study 2, the factor structure and construct validity of the HOS Italian version was assessed trough confirmatory factor analysis using a tobacco cigarette smokers and nonsmokers population. Two hundred and nineteen participants were enrolled; they were 164 women (75.2%) and 55 men (24.8%). Results In Study 1, a seven factors solution was obtained explaining 60% of cumulative variance instead of 10 factors solution of the original version of the HOS. In Study 2, the factor structure of the Italian version of the HOS was confirmed and applied to the smokers and nonsmokers; nonsmokers reported higher values than smokers in Factor 1 (MHPP) [t (208) = − 2.739 p

Mucosal enrichment of the Adherent-Invasive E. coli (AIEC) pathotype and the expansion of pathogenic IFNγ-producing Th17 (pTh17) cells have been linked to Crohn’s Disease (CD) pathogenesis. However, the molecular pathways underlying the AIEC-dependent pTh17 cell transdifferentiation in CD patients remain elusive. To this aim, we created and functionally screened a transposon AIEC mutant library of 10.058 mutants to identify the virulence determinants directly implicated in triggering IL-23 production and pTh17 cell generation. pTh17 cell transdifferentiation was assessed in functional assays by co-culturing AIEC-infected human dendritic cells (DCs) with autologous conventional Th17 (cTh17) cells isolated from blood of Healthy Donors (HD) or CD patients. AIEC triggered IL-23 hypersecretion and transdifferentiation of cTh17 into pTh17 cells selectively through the interaction with CD-derived DCs. Moreover, the chronic release of IL-23 by AIEC-colonized DCs required a continuous IL-23 neutralization to significantly reduce the AIEC-dependent pTh17 cell differentiation. The multi-step screenings of the AIEC mutant’s library revealed that deletion of ybaT or rfaP efficiently hinder the IL-23 hypersecretion and hampered the AIEC-dependent skewing of protective cTh17 into pathogenic IFNγ-producing pTh17 cells. Overall, our findings indicate that ybaT (inner membrane transport protein) and rfaP (LPS-core heptose kinase) represent novel and attractive candidate targets to prevent chronic intestinal inflammation in CD.

Abstract Muscle repair in dysferlinopathies is defective. Although macrophage (Mø)-rich infiltrates are prominent in damaged skeletal muscles of patients with dysferlinopathy, the contribution of the immune system to the disease pathology remains to be fully explored. Numbers of both pro-inflammatory M1 Mø and effector T cells are increased in muscle of dysferlin-deficient BlAJ mice. In addition, symptomatic BlAJ mice have increased muscle production of immunoproteasome. In vitro analyses using bone marrow-derived Mø of BlAJ mice show that immunoproteasome inhibition results in C3aR1 and C5aR1 downregulation and upregulation of M2-associated signaling. Administration of immunoproteasome inhibitor ONX-0914 to BlAJ mice rescues muscle function by reducing muscle infiltrates and fibro-adipogenesis. These findings reveal an important role of immunoproteasome in the progression of muscular dystrophy in BlAJ mouse and suggest that inhibition of immunoproteasome may produce therapeutic benefit in dysferlinopathy.

Background: Visuo-spatial and visuo-perceptual functioning is widely studied in preterm child and is strongly sex-specific. However, little to no data is available regarding male-female differences in preterm children and adolescents and about the interaction effect between sex and preterm birth., Methods: We studied 30 adolescents born preterm with normal cognitive and clinical neurological outcomes and 34 age-matched controls to investigate the interaction between levels of prematurity and sex in predicting the outcome of visual pathways functioning and to explore the relation between psychophysiological perceptive processing and neuropsychological performance., Results: In the presence of prematurity, a greater female vulnerability in central visuo-cognitive processing (Form Coherence Task), but not in neuropsychological accuracy (Street Completion Test and Visual Object and Space Perception battery), seems to be more evident. Moreover, the psychophysical threshold is correlated to neuropsychological accuracy only in preterm females and not in males., Conclusion: These results support the idea that the male vulnerability in cognitive functioning described in prematurity-related developmental conditions is negligible during school age in children-adolescents with normal cognitive and clinical neurological outcomes., Impact: Visuo-perceptual functioning is widely studied in prematurity. However, few data are available about the interaction effect between sex and preterm birth in predicting visuo-perceptual functioning. We evidenced that in females born preterm with preserved cognitive abilities, the efficiency of the psychophysical visuo-perceptual threshold is reduced, but not related to the neuropsychological performance. Females may implement compensation strategies to achieve good performance regardless of the perceptual threshold. The present study addresses an important gap in literature, suggesting possible sex-specific outcomes in visuo-perceptual ability among preterm children and adolescents with normal intelligence and neurological outcomes., (© 2024. The Author(s).)

The time course of socio-communicative disturbances in children after posterior fossa tumor resection is variable in clinical reports, and its assessment may help to understand the role of the cerebellum in the pathogenesis of socio-communicative disorders and improve rehabilitation plans. We report the 3-year cognitive-behavioral follow-up of a female patient (LZ) who underwent surgical ablation of the vermis due to medulloblastoma at age 9. LZ developed a severe post-operative Cerebellar Cognitive Affective Syndrome (CCAS) with cognitive-executive dysfunctions and behavioral alterations resembling an Autism Spectrum Disorder (ASD)-like syndrome. The lack of empathy and reduced ability to recognize others' intentions and mental states persisted at follow-up evaluations, as did language alterations. The present case report evidenced that lesions affecting cerebellar and vermal lobules may cause severe CCAS and impairment of social skills overlapping with that observed in ASD. This case is significant in its clinical features, revealing long-term social impairment, while the cognitive, linguistic, and executive functioning improved over time. Prospective case studies should plan the evaluation of symptoms of ASD within the clinical longitudinal assessment.

This article presents a revision of the literature regarding the influence of sex differences on the recovery and long-term behavioral and cognitive outcomes of preterm children. After initial discussion of some methodological concerns, the literature regarding the concept of "male disadvantage," which is often used when talking about early neurological and psychomotor outcomes in preterm children, is presented. Subsequently, the literature data on sex-related differences in preterm children are discussed, focusing on their influence on the developmental pathways of cognition, language, executive function, behavior and affect, and response to rehabilitation therapies. Finally, evidence about brain structural and connectivity correlates of sex differences in the brain of preterm survivors is taken into account. Although visuo-spatial and visuo-perceptual functioning is widely studied in the preterm child and is strongly sex specific, little to no data are available regarding male-female differences in preterm children and the interaction effect between sex and preterm birth. For this reason, original data analyses of male-female differences in visuo-spatial performance from a small sample of preterm children are also presented., (© 2021 Wiley Periodicals, LLC.)

Under the Bayesian brain hypothesis, behavioral variations can be attributed to different priors over generative model parameters. This provides a formal explanation for why individuals exhibit inconsistent behavioral preferences when confronted with similar choices. For example, greedy preferences are a consequence of confident (or precise) beliefs over certain outcomes. Here, we offer an alternative account of behavioral variability using Rényi divergences and their associated variational bounds. Rényi bounds are analogous to the variational free energy (or evidence lower bound) and can be derived under the same assumptions. Importantly, these bounds provide a formal way to establish behavioral differences through an α parameter, given fixed priors. This rests on changes in α that alter the bound (on a continuous scale), inducing different posterior estimates and consequent variations in behavior. Thus, it looks as if individuals have different priors and have reached different conclusions. More specifically, α→0+ optimization constrains the variational posterior to be positive whenever the true posterior is positive. This leads to mass-covering variational estimates and increased variability in choice behavior. Furthermore, α→+∞ optimization constrains the variational posterior to be zero whenever the true posterior is zero. This leads to mass-seeking variational posteriors and greedy preferences. We exemplify this formulation through simulations of the multiarmed bandit task. We note that these α parameterizations may be especially relevant (i.e., shape preferences) when the true posterior is not in the same family of distributions as the assumed (simpler) approximate density, which may be the case in many real-world scenarios. The ensuing departure from vanilla variational inference provides a potentially useful explanation for differences in behavioral preferences of biological (or artificial) agents under the assumption that the brain performs variational Bayesian inference., (© 2022 Massachusetts Institute of Technology.)

Young cancer survivors often wish to bear a child after oncological treatments, as they might not have started or completed their families. As young cancer survivors have a higher risk of developing psychological difficulties, this study investigated whether there were significant differences in psychological aspects between pregnant women who received a cancer diagnosis in the past and pregnant women without a history of cancer. A total of 123 pregnant women, of which 36 were cancer survivors and 87 women without a history of cancer, were recruited during their last trimester at different hospitals in Northern Italy. Patients were asked to complete a socio-demographic profile and questionnaires measuring mood states, post-traumatic symptoms, centrality of the pregnancy and cancer event, quality of life, and prenatal attachment. Cancer survivors had significantly higher levels of PTSD symptoms, perceived pregnancy as more central to their identity and life story, perceived lower quality of life and had lower intensity of prenatal attachment compared with the control group. Centrality of the cancer event did not correlate with any psychological variables. Preliminary results suggest that a past cancer diagnosis can influence the mother's psychological functioning and the development of the relationship with their child.

Background: A novel approach suggested that cognitive and dispositional features may explain in depth the health behaviors adoption and the adherence to prevention programs. The Health Orientation Scale (HOS) has been extensively used to map the adoption of health and unhealthy behaviors according to cognitive and dispositional features. Coherently, the main aim of the current research was to assess the factor structure of the Italian version of the HOS using exploratory and confirmatory factor analysis and testing the construct validity of the scale by assessing differences in health orientations between tobacco cigarette smokers and nonsmokers., Method: The research protocol was organized in two studies. Study 1 evaluated the dimensionality of the HOS in a sample of Northern Italian healthy people. Three hundred and twenty-one participants were enrolled; they were 229 women (71.3%) and 92 men (28.7%). In Study 2, the factor structure and construct validity of the HOS Italian version was assessed trough confirmatory factor analysis using a tobacco cigarette smokers and nonsmokers population. Two hundred and nineteen participants were enrolled; they were 164 women (75.2%) and 55 men (24.8%)., Results: In Study 1, a seven factors solution was obtained explaining 60% of cumulative variance instead of 10 factors solution of the original version of the HOS. In Study 2, the factor structure of the Italian version of the HOS was confirmed and applied to the smokers and nonsmokers; nonsmokers reported higher values than smokers in Factor 1 (MHPP) [t (208) = - 2.739 p < .007] (CI 95-4.96% to -.809), Factor 2 (HES) [t (209) = - 3.387 p < .001] (CI 95-3.93% to -. 1.03), Factor 3 (HIC) [t(213) = - 2.468 p < .014] (CI 95-2.56% to -.28) and Factor 7 (HEX) [t(217) = - 3.451 p < .001] (CI 95%- 1.45 to .39)., Conclusions: Results of the Italian adaptation of HOS lead to a partial redistribution of items and confirmed 7 subscales to distinguish psycho-cognitive dispositional dimensions involved in health orientation styles.

Objective: Little is known about the process of becoming a mother in women who experienced a breast cancer diagnosis (BC). In this qualitative study, we investigated maternal representations in pregnant women with experience of BC and those with no oncological history., Methods: A total of 38 women were recruited, 19 women who experienced a BC diagnosis and 19 who had not. To explore maternal representations, semi-structured interviews were conducted and analysed through thematic analysis., Results: Four main themes were identified: fears and worries, meaning of motherhood, mother-foetus relationship and partner support. Across themes, differences between primiparous and multiparous are reported. Women with gestational breast cancer (GBC) described fear for their own and their child's survival. Women with previous BC recall contrasting emotions. All women with experience of BC perceived breastfeeding as fundamental and inability to do so provoked worry. Relationship with the partner was considered central, while healthy women were projected towards the future triadic relationship., Conclusions: Finding a mental space during pregnancy for the representation of the future child could be hard for women with GBC. Dissimilarities in the experience of motherhood in cancer patients provide insight into psychological aspects that should be taken into account in clinical practice., (© 2020 John Wiley & Sons Ltd.)

Young breast cancer patients face numerous challenges during the cancer trajectory. As in the last decade, women tend to delay pregnancies to a later time in life, and clinicians are often faced with young breast cancer patients who want to start a family or complete it. Becoming a mother is a delicate developmental process in which the woman redefines and restructures her identity as she gets prepared for her new role and responsibilities. When there is a history of cancer or cancer diagnosis is communicated during the pregnancy, fears, worries, and concerns emerge and specific support may be necessary. Follow-ups during the post-partum period are also recommended as lactation issues should not be overlooked. In this chapter, we analyze the psychological aspects of cancer survivors and women with pregnancy-associated breast cancer, and the management of these issues.

Objective: Develop and validate an instrument to assess family resilience and, more specifically, the family dynamics and resources, estimating the adaptation flexibility to cancer disease. Cohesion, communication, coping style and relational style were considered as critical functional areas in the construction of the instrument., Design: Two cross-sectional studies. Study 1: identification of factorial structure of the questionnaire in two samples with different cancer sites. Study 2: validation of the questionnaire in patients with cancer in two different phases of their therapeutic pathway., Participants and Setting: A total of 213 patients with a histologically confirmed non-metastatic breast or prostate cancer and 209 caregivers were recruited for the two studies from an oncological hospital in Italy., Outcome Measures: The Resilience Scale for Adults and the Family Resilience (FaRE) Questionnaire, developed by the researchers, were administered to all patients and caregivers who gave consent., Results: In study 1, the 60-item version of the FaRE Questionnaire underwent discriminant and construct validity, internal consistency and factorial analysis. Comparisons between patient and caregiver populations showed that patients perceived higher levels of family resources (p=0.048) and that patients with prostate cancer perceived less social support compared with patients with breast cancer (p=0.002). Factor analysis demonstrated four domains: communication and cohesion, perceived social support, perceived family coping, and religiousness and spirituality. In study 2, the validity and factorial structure of the final scale, composed of 24 items, were confirmed. The Cronbach alpha of all subscales was above 82. Normative values for patients with breast cancer can provide indications of family resilience levels., Conclusions: Preliminary findings showed acceptable psychometric properties for the FaRE Questionnaire to evaluate family resilience in oncological patients and their caregivers. Further research should test its sensibility to change to assess its use as a psychoemotional monitoring tool and its validity in other medical contexts., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Purpose: Cancer treatments often produce undesirable side-effects, such as skin toxicity, impacting on everyday functioning and health-related quality of life (HRQoL). This experimental study sought to determine whether aesthetic products and treatments could significantly decrease perceived skin symptoms, psychological distress and improve skin-related QoL (SRQoL)., Methods: An experimental group composed of 100 breast patients was enrolled for specialized aesthetic treatments at the European Institute of Oncology (IEO) and compared to a control group of 70 breast patients who did not receive any aesthetic treatment. A measure of SRQoL (i.e., Skindex-16) and a distress thermometer were administered longitudinally at three time points: at baseline (T0), at 7 days from beginning of aesthetic treatment (T1) and at 28 days from beginning of aesthetic treatment (T2)., Results: Results demonstrated the efficacy of aesthetic treatment in reducing distress and improving SRQoL: while the experimental group showed significant improvements in all HRQoL areas, the control group worsened. Specifically, at T1 and T2 there were significant improvements on distress and Skindex subscales in the experimental group, with an almost complete remission of perceived symptoms at T2. Moreover, all reported cutaneous reactions significantly improved after the specialized treatments, with no differences in SRQoL in skin reaction type., Conclusions: These findings demonstrate that aesthetic treatments for side-effects of cancer therapies can alleviate perceived distress and improve skin symptoms and HRQoL.

Background: Research has been mainly focused on how to elicit patient preferences, with less attention on why patients form certain preferences., Objectives: To assess which psychological instruments are currently used and which psychological constructs are known to have an impact on patients' preferences and health-related decisions including the formation of preferences and preference heterogeneity., Methods: A systematic database search was undertaken to identify relevant studies. From the selected studies, the following information was extracted: study objectives, study population, design, psychological dimensions investigated, and instruments used to measure psychological variables., Results: Thirty-three studies were identified that described the association between a psychological construct, measured using a validated instrument, and patients' preferences or health-related decisions. We identified 33 psychological instruments and 18 constructs, and categorized the instruments into 5 groups, namely, motivational factors, cognitive factors, individual differences, emotion and mood, and health beliefs., Conclusions: This review provides an overview of the psychological factors and related instruments in the context of patients' preferences and decisions in healthcare settings. Our results indicate that measures of health literacy, numeracy, and locus of control have an impact on health-related preferences and decisions. Within the category of constructs that could explain preference and decision heterogeneity, health locus of control is a strong predictor of decisions in several healthcare contexts and is useful to consider when designing a patient preference study. Future research should continue to explore the association of psychological constructs with preference formation and heterogeneity to build on these initial recommendations., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: We performed an observational prospective cohort study to investigate post-traumatic stress symptoms, emerging after cancer diagnosis, which could influence patients' short- and long-term adjustment to illness, in order to foster screening measures and management of psychological factors in daily clinical pathways., Methods: Patients' post-traumatic stress symptoms, psychological well-being and perceived quality of life were assessed through standardised questionnaires. The Profile of Mood States questionnaire was administered at pre-operative assessment (T0), surgical admission (T1) and discharge from hospital (T2). The Impact of Event Scale and the State-Trait Anxiety Inventory were administered at T0, T1, T2 and 2 years after discharge (T3). At 2-year follow-up, women were also asked to rate their perceived quality of life on a 0-10 visual analogue scale., Results: Between January 2014 and April 2015, 150 women were enrolled. Results showed that more than 90% of patients experienced post-traumatic stress symptoms after cancer diagnosis (14% with severe symptoms and 76.7% with moderate symptoms) and post-traumatic stress disorder (PTSD) symptoms that persisted up to the 2-year from discharge follow-up, with significant improvement only 2 years after hospital discharge. In particular, mediation models showed that intrusive thoughts impede mood adjustment to the disease during the pre-surgical phase, with anxiety amplifying the negative effect, while symptoms of avoidance are more detrimental in the long term for patients' quality of life., Conclusion: PTSD symptom clusters have different influence on short- and long-term reaction to illness. Based on this evidence, appropriate interventions to manage PTSDs in the context of oncology should be developed., Competing Interests: The authors declare that they have no conflicts of interest.

Children may experience intense stress when faced with symptoms of parental illness, as disruption of family routines and temporary unavailability of the parent occurs. This review aimed to analyse the psychological impact of parental cancer diagnosis in families with dependent children and identify protective and risk factors for child adjustment. Using preselected keywords, a systematic search of six electronic abstract databases was conducted. Studies had to investigate the psychological impact on children under 18 years old, had to measure psychosocial functioning quantitatively and had to be published in English in peer-reviewed journals between 1990 and 2017. Twenty-six studies met the inclusion criteria. A thematic analysis was undertaken to establish the main themes: (a) Psychological symptoms, (b) Global functioning and well-being, (c) Coping strategies and (d) Parent and family-related factors. Coping strategies and family functioning seem to be predictors of the child's psychological well-being. Adolescents are more likely to develop emotional and behavioural symptoms compared with children. However, the heterogeneity of the findings and study designs does not allow for strong conclusions to be drawn. These preliminary results should be considered when developing screening programmes for children whose parents are diagnosed with cancer., (© 2018 John Wiley & Sons Ltd.)

Background: Whole Body magnetic resonance imaging (WB-MRI) enables early cancer detection, without exposing the patient to ionizing radiation. Our aim was to investigate patients' acceptance of WB-MRI as a procedure for cancer staging and follow up., Materials and Methods: 135 oncologic subjects participated to the study. An ad hoc questionnaire was administered before and after WB-MRI, to assess patient's confidence and concerns about WB-MRI, psychological reactions, experience and perceived utility of the procedure., Results: Before undergoing WB-MRI, about 58% of the patients were concerned for cancer progression outcome. 80.4% felt that they were given good information about the exam and the most informed group also perceived and higher level of utility of WB-MRI and no risk. Among people reporting discomfort with the exam (51.9%) the main reasons were noise and exam duration. Despite this, 80% of patients expressed high levels of satisfaction, and the majority (69%) judged WB-MRI more acceptable than other diagnostic exams. Patients who believed to have received more information before the exam rated their global satisfaction higher., Conclusion: Our results show that WB-MRI examinations were well-accepted and perceived with high levels of satisfaction by most patients. WB-MRI appears to be equally or more tolerable than other total body imaging modalities (e.g. PET, CT), especially if they receive enough information from the radiologist., (Copyright © 2018 Elsevier Inc. All rights reserved.)

In the last decade, clinicians have started to shift from an individualistic perspective of the patient towards family-centred models of care, due to the increasing evidence from research and clinical practice of the crucial role of significant others in determining the patient's adjustment to cancer disease and management. eHealth tools can be considered a means to compensate the services gap and support outpatient care flows. Within the works of the European H2020 iManageCancer project, a review of the literature in the field of family resilience was conducted, in order to determine how to monitor the patient and his/her family's resilience through an eHealth platform. An analysis of existing family resilience questionnaires suggested that no measure was appropriate for cancer patients and their families. For this reason, a new family resilience questionnaire (named FaRe) was developed to screen the patient's and caregiver's psycho-emotional resources. Composed of 24 items, it is divided into four subscales: Communication and Cohesion, Perceived Family Coping, Religiousness and Spirituality, and Perceived Social Support. Embedded in the iManageCancer eHealth platform, it allows users and clinicians to monitor the patient's and the caregivers' resilience throughout the cancer trajectory.

Resilience is a concept that has received burgeoning interest in the last decades. Researchers have been fascinated by the ability of some individuals to bounce back from an adverse event and adapt to extremely challenging situations. More recently family resilience, namely the potential resources of the family's system, has been considered due to numerous individual studies highlighting the crucial influence of relationships with significant others in mediating adaptation and recovery. In this article, a brief overview of the theoretical literature on individual and family resilience is presented. Following, current empirical literature on resilience in the context of oncology is evaluated. Although family resilience is considered a dynamic process unique to each family unit, some common resources and strengths that can help families face significant adversities, such as cancer, can be identified. This said to date there is no family resilience framework applied specifically to the cancer trajectory. Drawing from previous studies, we sought to provide a clinical resilience model for families living with cancer, with the aim of mapping those resources that can empower families to deal with prolonged adversity. This framework can serve as general guideline for health professionals in assessing family strengths, promoting specific family processes and facilitating adaptation to the cancer experience.

Background: Cancer during pregnancy is a rare event. However, knowledge about treatment has progressed in recent years with improved maternal and neonatal outcomes. The number of women who decide to continue their pregnancy and undergo cancer treatment is increasing., Main Body: Women face two critical events simultaneously; oncological illness and pregnancy, with different and conflicting emotions. In addition, the last trimester of gestation sets the ground for construction of the mother-child relationship, which is of great importance for the child's development. Studies have showed that maternal exposure to stressful events during pregnancy is linked to adverse outcomes in children. Although several authors consider cancer to be a 'critical life event', studies that address the psychosocial implications of cancer in expecting mothers are scarce. There are no studies addressing the possible negative impact of a cancer diagnosis during pregnancy on the mother-child relationship and on the child's development. It is important to emphasize the need for in-depth knowledge of the contributing psychological factors involved in order to provide holistic, individualised, and supportive care., Conclusion: An analysis of cognitive aspects, emotional processes, and maternal attachment in cases of cancer during pregnancy may contribute to the development of a model of care, both in an evolutionary and in a psycho-oncology context, with implications for clinical practice.

Purpose: Based on our preclinic studies with autologous unfractionated bone marrow (AUBM) via coronary sinus with transitory occlusion, a clinic study in patients with chronic refractory angina was designed. The objectives were to evaluate tolerance of the procedure, safety, and feasibility with 1 year follow-up., Methods and Materials: Clinical study with inclusion and exclusion criteria defined by an Independent Clinical Committee was carried out. Fifteen patients underwent transcoronary sinus administration with a 15-min occlusion of freshly aspirated and filtered AUBM (60-120 ml). Feasibility was evaluated with Seattle Angina Questionnaire (SAQ), Canadian Cardiovascular Society (CCS) angina classification, perfusion dipyridamole, and coronary angiography., Results: There were no changes in the tolerance parameters. There were no deaths or myocardial infarction during the follow-up. Three patients were readmitted into the hospital. During the follow-up, one patient was diagnosed with cancer of the lung. Improvement of 30% in the quality of life was evaluated by SAQ. The CCS angina classification showed that the mean angina class was 3.0+/-0.53 at baseline, which improved to 1.6+/-0.63 at 1 year (P<.001). Perfusion imaging (core lab) showed improvement in 12 of 15 patients, with a mean improvement of 40.9% at rest (22 vs. 13) (P<.01) and 45.3% at stress (26.5 vs. 14.5) (P<.05). Coronary angiography showed more collateral vessels in 10 of 15 patients., Conclusions: We can conclude that AUBM via coronary sinus is feasible in patients with chronic refractory angina after 1 year follow-up, and it appears to be safe.

Purpose: Based on our preclinic studies with autologous unfractionated bone marrow (AUBM) via coronary sinus with transitory occlusion, a clinic study in patients with chronic stable angina was designed. The objectives were to evaluate safety, tolerance and feasibility., Methods and Materials: A multicenter prospective study with inclusion and exclusion criteria defined by an Independent Clinical Committee was carried out. Fourteen patients underwent transcoronary sinus administration of freshly aspirated and filtered AUBM (60-120 ml). Safety and tolerance were evaluated. Feasibility was evaluated with Seattle Angina Questionnaire (SAQ), Canadian Cardiovascular Society (CCS) angina classification (baseline-Day 180), myocardial perfusion (baseline-Day 90) with independent core laboratory and coronary angiography (baseline and Day 30)., Results: There were no changes in the safety and tolerance parameters. Preliminary clinical efficacy at Day 180 disclosed a significant improvement of 38%, evaluated by the SAQ. The CCS angina classification shows that the mean angina class was 3.0+/-0.55 at baseline and improved to 2.0+/-0.00 at Day 180 (P <.001). Semiquantitative radionuclide perfusion imaging (core lab) showed a significant improvement at Day 90 in 13/14 patients, with a mean improvement of 24% at rest (P <.01) and 33% at stress (P <.05). Coronary angiography showed more collateral vessels in 9/14 patients., Conclusions: We can conclude that AUBM via coronary sinus with transitory occlusion is tolerable and safe. Significant improvement in the myocardial perfusion at Day 90 and in the quality of life at Day 180 was observed.