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1. Safety outcomes and patients’ preferences for home-based intravenous enzyme replacement therapy (ERT) in pompe disease and mucopolysaccharidosis type I (MPS I) disorder: COVID-19 and beyond

Author

Toscano, Antonio, Musumeci, Olimpia, Sacchini, Michele, Ravaglia, Sabrina, Siciliano, Gabriele, Fiumara, Agata, Verrecchia, Elena, Maione, Melania, Gentile, Jennifer, Fischetto, Rita, Crescimanno, Grazia, Taurisano, Roberta, Sechi, Annalisa, Gasperini, Serena, Cianci, Vittoria, Maggi, Lorenzo, Parini, Rossella, Lupica, Antonino, and Scarpa, Maurizio

Published
2023
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3. Intrafamilial variability in the clinical manifestations of mucopolysaccharidosis type II: Data from the Hunter Outcome Survey (HOS)

Author

Ficicioglu, Can, Giugliani, Roberto, Harmatz, Paul, Mendelsohn, Nancy J, Jego, Virginie, and Parini, Rossella

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Adolescent, Age of Onset, Biological Variation, Individual, Child, Child, Preschool, Family, Humans, Male, Mucopolysaccharidosis II, Phenotype, Registries, Siblings, Surveys and Questionnaires, Symptom Assessment, clinical heterogeneity, Hunter syndrome, idursulfase, lysosomal storage disease, siblings, Genetics, Clinical sciences
Abstract

Several cases of phenotypic variability among family members with mucopolysaccharidosis type II (MPS II) have been reported, but the data are limited. Data from patients enrolled in the Hunter Outcome Survey (HOS) were used to investigate intrafamilial variability in male siblings with MPS II. As of July 2015, data were available for 78 patients aged ≥5 years at last visit who had at least one affected sibling (39 sibling pairs). These patients were followed prospectively (i.e., they were alive at enrollment in HOS). The median age at the onset of signs and symptoms was the same for the elder and younger brothers (2.0 years); however, the younger brothers were typically diagnosed at a younger age than the elder brothers (median age, 2.5 and 5.1 years, respectively). Of the 39 pairs, eight pairs were classified as being discordant (the status of four or more signs and symptoms differed between the siblings); 21 pairs had one, two, or three signs and symptoms that differed between the siblings, and 10 pairs had none. Regression status of the majority of the developmental milestones studied was generally concordant among siblings. Functional classification, a measure of central nervous system involvement, was the same in 24/28 pairs, although four pairs were considered discordant as functional classification differed between the siblings. Overall, this analysis revealed similarity in the clinical manifestations of MPS II among siblings. This information should help to improve our understanding of the clinical presentation of the disease, including phenotype prediction in affected family members.

Published
2018

4. Clinical and radiological correlates of activities of daily living in cerebellar atrophy caused by PMM2 mutations (PMM2-CDG)

Author

Pettinato, Fabio, Mostile, Giovanni, Battini, Roberta, Martinelli, Diego, Madeo, Annalisa, Biamino, Elisa, Frattini, Daniele, Garozzo, Domenico, Gasperini, Serena, Parini, Rossella, Sirchia, Fabio, Sortino, Giuseppe, Sturiale, Luisa, Matthijs, Gert, Morrone, Amelia, Di Rocco, Maja, Rizzo, Renata, Jaeken, Jaak, Fiumara, Agata, and Barone, Rita

Published
2021
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5. Early skeletal outcomes after hematopoietic stem and progenitor cell gene therapy for Hurler syndrome

Author

Consiglieri, G, Tucci, F, De Pellegrin, M, Guerrini, B, Cattoni, A, Risca, G, Scarparo, S, Sarzana, M, Pontesilli, S, Mellone, R, Gasperini, S, Galimberti, S, Silvani, P, Filisetti, C, Darin, S, Forni, G, Miglietta, S, Santi, L, Facchini, M, Corti, A, Fumagalli, F, Cicalese, M, Calbi, V, Migliavacca, M, Barzaghi, F, Ferrua, F, Gallo, V, Recupero, S, Canarutto, D, Doglio, M, Tedesco, L, Volpi, N, Rovelli, A, la Marca, G, Valsecchi, M, Zancan, S, Ciceri, F, Naldini, L, Baldoli, C, Parini, R, Gentner, B, Aiuti, A, Bernardo, M, Consiglieri, Giulia, Tucci, Francesca, De Pellegrin, Maurizio, Guerrini, Barbara, Cattoni, Alessandro, Risca, Giulia, Scarparo, Stefano, Sarzana, Marina, Pontesilli, Silvia, Mellone, Renata, Gasperini, Serena, Galimberti, Stefania, Silvani, Paolo, Filisetti, Chiara, Darin, Silvia, Forni, Giulia, Miglietta, Simona, Santi, Ludovica, Facchini, Marcella, Corti, Ambra, Fumagalli, Francesca, Cicalese, Maria Pia, Calbi, Valeria, Migliavacca, Maddalena, Barzaghi, Federica, Ferrua, Francesca, Gallo, Vera, Recupero, Salvatore, Canarutto, Daniele, Doglio, Matteo, Tedesco, Lucia, Volpi, Nicola, Rovelli, Attilio, la Marca, Giancarlo, Valsecchi, Maria Grazia, Zancan, Stefano, Ciceri, Fabio, Naldini, Luigi, Baldoli, Cristina, Parini, Rossella, Gentner, Bernhard, Aiuti, Alessandro, Bernardo, Maria Ester, Consiglieri, G, Tucci, F, De Pellegrin, M, Guerrini, B, Cattoni, A, Risca, G, Scarparo, S, Sarzana, M, Pontesilli, S, Mellone, R, Gasperini, S, Galimberti, S, Silvani, P, Filisetti, C, Darin, S, Forni, G, Miglietta, S, Santi, L, Facchini, M, Corti, A, Fumagalli, F, Cicalese, M, Calbi, V, Migliavacca, M, Barzaghi, F, Ferrua, F, Gallo, V, Recupero, S, Canarutto, D, Doglio, M, Tedesco, L, Volpi, N, Rovelli, A, la Marca, G, Valsecchi, M, Zancan, S, Ciceri, F, Naldini, L, Baldoli, C, Parini, R, Gentner, B, Aiuti, A, Bernardo, M, Consiglieri, Giulia, Tucci, Francesca, De Pellegrin, Maurizio, Guerrini, Barbara, Cattoni, Alessandro, Risca, Giulia, Scarparo, Stefano, Sarzana, Marina, Pontesilli, Silvia, Mellone, Renata, Gasperini, Serena, Galimberti, Stefania, Silvani, Paolo, Filisetti, Chiara, Darin, Silvia, Forni, Giulia, Miglietta, Simona, Santi, Ludovica, Facchini, Marcella, Corti, Ambra, Fumagalli, Francesca, Cicalese, Maria Pia, Calbi, Valeria, Migliavacca, Maddalena, Barzaghi, Federica, Ferrua, Francesca, Gallo, Vera, Recupero, Salvatore, Canarutto, Daniele, Doglio, Matteo, Tedesco, Lucia, Volpi, Nicola, Rovelli, Attilio, la Marca, Giancarlo, Valsecchi, Maria Grazia, Zancan, Stefano, Ciceri, Fabio, Naldini, Luigi, Baldoli, Cristina, Parini, Rossella, Gentner, Bernhard, Aiuti, Alessandro, and Bernardo, Maria Ester

Abstract

Mucopolysaccharidosis type I Hurler (MPSIH) is characterized by severe and progressive skeletal dysplasia that is not fully addressed by allogeneic hematopoietic stem cell transplantation (HSCT). Autologous hematopoietic stem progenitor cell-gene therapy (HSPC-GT) provides superior metabolic correction in patients with MPSIH compared with HSCT; however, its ability to affect skeletal manifestations is unknown. Eight patients with MPSIH (mean age at treatment: 1.9 years) received lentiviral-based HSPC-GT in a phase 1/2 clinical trial (NCT03488394). Clinical (growth, measures of kyphosis and genu velgum), functional (motor function, joint range of motion), and radiological [acetabular index (AI), migration percentage (MP) in hip x-rays and MRIs and spine MRI score] parameters of skeletal dysplasia were evaluated at baseline and multiple time points up to 4 years after treatment. Specific skeletal measures were retrospectively compared with an external cohort of HSCT-treated patients. At a median follow-up of 3.78 years after HSPC-GT, all patients treated with HSPC-GT exhibited longitudinal growth within WHO reference ranges and a median height gain greater than that observed in patients treated with HSCT after 3-year follow-up. Patients receiving HSPC-GT experienced complete and earlier normalization of joint mobility compared with patients treated with HSCT. Mean AI and MP showed progressive decreases after HSPC-GT, suggesting a reduction in acetabular dysplasia. Typical spine alterations measured through a spine MRI score stabilized after HSPC-GT. Clinical, functional, and radiological measures suggested an early beneficial effect of HSPC-GT on MPSIH-typical skeletal features. Longer follow-up is needed to draw definitive conclusions on HSPC-GT's impact on MPSIH skeletal dysplasia.

Published
2024

6. Brain function in classic galactosemia, a galactosemia network (GalNet) members review

Author

Panis, Bianca, primary, Vos, E. Naomi, additional, Barić, Ivo, additional, Bosch, Annet M., additional, Brouwers, Martijn C. G. J., additional, Burlina, Alberto, additional, Cassiman, David, additional, Coman, David J., additional, Couce, María L., additional, Das, Anibh M., additional, Demirbas, Didem, additional, Empain, Aurélie, additional, Gautschi, Matthias, additional, Grafakou, Olga, additional, Grunewald, Stephanie, additional, Kingma, Sandra D. K., additional, Knerr, Ina, additional, Leão-Teles, Elisa, additional, Möslinger, Dorothea, additional, Murphy, Elaine, additional, Õunap, Katrin, additional, Pané, Adriana, additional, Paci, Sabrina, additional, Parini, Rossella, additional, Rivera, Isabel A., additional, Scholl-Bürgi, Sabine, additional, Schwartz, Ida V. D., additional, Sdogou, Triantafyllia, additional, Shakerdi, Loai A., additional, Skouma, Anastasia, additional, Stepien, Karolina M., additional, Treacy, Eileen P., additional, Waisbren, Susan, additional, Berry, Gerard T., additional, and Rubio-Gozalbo, M. Estela, additional

Published
2024
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7. Impact of long‐term elosulfase alfa treatment on respiratory function in patients with Morquio A syndrome

Author

Hendriksz, Christian J, Berger, Kenneth I, Parini, Rossella, AlSayed, Moeenaldeen D, Raiman, Julian, Giugliani, Roberto, Mitchell, John J, Burton, Barbara K, Guelbert, Norberto, Stewart, Fiona, Hughes, Derralynn A, Matousek, Robert, Jurecki, Elaina, Decker, Celeste, and Harmatz, Paul R

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Lung, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adolescent, Adult, Aged, Child, Child, Preschool, Chondroitinsulfatases, Double-Blind Method, Enzyme Replacement Therapy, Female, Forced Expiratory Volume, Humans, Long-Term Care, Male, Middle Aged, Mucopolysaccharidosis IV, Respiration, Respiratory Function Tests, Young Adult, Genetics & Heredity, Genetics, Clinical sciences
Abstract

ObjectiveTo present long-term respiratory function outcomes from an open-label, multi-center, phase 3 extension study (MOR-005) of elosulfase alfa enzyme replacement therapy (ERT) in patients with Morquio A syndrome.MethodsIn part 1 of MOR-005, patients initially randomized to ERT in the 24-week pivotal study (MOR-004) remained on their regimen (2.0 mg/kg/week or every other week); placebo patients were re-randomized to one of the two regimens. During part 2, all patients received elosulfase alfa 2.0 mg/kg/week. Respiratory function was one of the efficacy endpoints evaluated in MOR-005. Change from MOR-004 baseline to 120 weeks of treatment for the combined population was determined and compared with results from untreated patients from a Morquio A natural history study (MorCAP).ResultsMaximum voluntary ventilation (MVV) improved up to week 72 and then stabilized; forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV1) increased continuously over 120 weeks. Mean increases in the modified per-protocol population was 9.2 % for FVC, 8.8 % for FEV1, and 6.1 % for MVV after 120 weeks. All patients ≤14 years showed respiratory improvements, presumably in part related to growth; however, these were greater in treated patients. For those >14 years, treated patients showed improvements, while deterioration occurred in untreated. Altogether, the improvements were significantly greater (P

Published
2016

8. Safety and clinical activity of elosulfase alfa in pediatric patients with Morquio A syndrome (mucopolysaccharidosis IVA) less than 5 y

Author

Jones, Simon A, Bialer, Martin, Parini, Rossella, Martin, Ken, Wang, Hui, Yang, Ke, Shaywitz, Adam J, and Harmatz, Paul

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Age Factors, Biomarkers, Body Height, Child Development, Child, Preschool, Chondroitinsulfatases, Drug Administration Schedule, Early Medical Intervention, Enzyme Replacement Therapy, Europe, Female, Humans, Infant, Infusions, Intravenous, Keratan Sulfate, Male, Mucopolysaccharidosis IV, Recombinant Proteins, Time Factors, Treatment Outcome, United Kingdom, Paediatrics and Reproductive Medicine, Public Health and Health Services, Pediatrics, Paediatrics
Abstract

BackgroundPrevious studies have shown that elosulfase alfa has a favorable efficacy/safety profile in Morquio A patients aged ≥5 y. This study evaluated safety and impact on urine keratan sulfate (uKS) levels and growth velocity in younger patients.MethodsFifteen Morquio A patients aged

Published
2015

9. Growth Charts for Individuals with Mucopolysaccharidosis VI (Maroteaux–Lamy Syndrome)

Author

Quartel, Adrian, Hendriksz, Christian J, Parini, Rossella, Graham, Sue, Lin, Ping, and Harmatz, Paul

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Mucopolysaccharidoses (MPS), Rare Diseases, Clinical Trials and Supportive Activities, Clinical Research, Digestive Diseases, Clinical sciences
Abstract

BackgroundThe skeletal phenotype of mucopolysaccharidosis VI (MPS VI) is characterized by short stature and growth failure.ObjectiveThe purpose of this study was to construct reference growth curves for MPS VI patients with rapidly and slowly progressive disease.MethodsWe pooled cross-sectional and longitudinal height for age data from galsulfase (Naglazyme(®), BioMarin Pharmaceutical Inc.), treatment naïve patients (n = 269) who participated in various MPS VI studies, including galsulfase clinical trials and their extension programs, the MPS VI clinical surveillance program (CSP), and the MPS VI survey and resurvey studies, to construct growth charts for the MPS VI population. There were 229 patients included in this study, of which data from 207 patients ≤25 years of age with 513 height measurements were used for constructing reference growth curves.ResultsHeight for age growth curves for the 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles were constructed for patients with rapidly and slowly progressing disease defined by the pre-enzyme replacement therapy (ERT) uGAG levels of > or ≤200 μg/mg creatinine. The mean (SD) pre-ERT uGAG levels were 481.0 (218.6) and 97.8 (56.3) μg/mg creatinine for the patients ≤25 years of age with rapidly (n = 131) and slowly (n = 76) progressing MPS VI disease, respectively. The median growth curves for patients with ≤ and >200 μg/mg creatinine were above and below the median (50th percentile) growth curve for the entire MPS VI population.ConclusionMPS VI growth charts have been developed to assist in the clinical management of MPS VI patients.

Published
2014

10. Long-term outcome of a cohort of Italian patients affected with alpha-Mannosidosis

Author

Bertolini, Anna, primary, Rigoldi, Miriam, additional, Cianflone, Annalia, additional, Mariani, Raffaella, additional, Piperno, Alberto, additional, Canonico, Francesco, additional, Cefalo, Graziella, additional, Carubbi, Francesca, additional, Simonati, Alessandro, additional, Urban, Maria Letizia, additional, Beccari, Tommaso, additional, and Parini, Rossella, additional

Published
2023
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12. P1392: INTERIM ANALYSIS OF FIRST IN HUMAN PHASE I-II CLINICAL TRIAL OF EX-VIVO GENE THERAPY FOR HURLER SYNDROME: AN UPDATE AT 3 YEAR FOLLOW-UP

Author

Tucci, Francesca, primary, Consiglieri, Giulia, additional, Filisetti, Chiara, additional, De Pellegrin, Maurizio, additional, Mellone, Renata, additional, Fumagalli, Francesca, additional, Darin, Silvia, additional, Sarzana, Marina, additional, Scarparo, Stefano, additional, Ciotti, Francesca, additional, Silvani, Paolo, additional, Baldoli, Cristina, additional, Pontesilli, Silvia, additional, Parini, Rossella, additional, la Marca, Giancarlo, additional, Ciceri, Fabio, additional, Naldini, Luigi, additional, Aiuti, Alessandro, additional, Gentner, Bernhard, additional, and Ester Bernardo, Maria, additional

Published
2023
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13. Vitamin E Improves Clinical Outcome of Patients Affected by Glycogen Storage Disease Type Ib

Author

Melis, Daniela, Minopoli, Giorgia, Balivo, Francesca, Marcolongo, Paola, Parini, Rossella, Paci, Sabrina, Dionisi-Vici, Carlo, Della Casa, Roberto, Benedetti, Angelo, Andria, Generoso, Parenti, Giancarlo, Morava, Eva, editor, Baumgartner, Matthias, editor, Patterson, Marc, editor, Rahman, Shamima, editor, Zschocke, Johannes, editor, and Peters, Verena, editor

Published
2016
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14. Treatment of thoracolumbar kyphosis in patients with mucopolysaccharidosis type I: results of an international consensus procedure

Author

Kuiper, Gé-Ann, Langereis, Eveline J., Breyer, Sandra, Carbone, Marco, Castelein, René M., Eastwood, Deborah M., Garin, Christophe, Guffon, Nathalie, van Hasselt, Peter M., Hensman, Pauline, Jones, Simon A., Kenis, Vladimir, Kruyt, Moyo, van der Lee, Johanna H., Mackenzie, William G., Orchard, Paul J., Oxborrow, Neil, Parini, Rossella, Robinson, Amy, Schubert Hjalmarsson, Elke, White, Klane K., and Wijburg, Frits A.

Published
2019
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15. Role of β‐galactosidase and elastin binding protein in lysosomal and nonlysosomal complexes of patients with GM1‐gangliosidosis

Author

Caciotti, Anna, Donati, Maria Alice, Boneh, Avihu, d'Azzo, Alessandra, Federico, Antonio, Parini, Rossella, Antuzzi, Danielas, Bardelli, Tiziana, Nosi, Daniele, Kimonis, Virginia, Zammarchi, Enrico, and Morrone, Amelia

Subjects
Biochemistry and Cell Biology, Biological Sciences, Genetics, Aetiology, 2.1 Biological and endogenous factors, Adult, Alternative Splicing, Amino Acid Sequence, Amino Acid Substitution, Animals, COS Cells, Cathepsin A, Cells, Cultured, Chlorocebus aethiops, Elastic Tissue, Female, Fibroblasts, Gangliosidosis, GM1, Humans, Infant, Infant, Newborn, Lysosomes, Male, Molecular Sequence Data, Multiprotein Complexes, Mutation, Missense, Phenotype, Protein Binding, Protein Folding, Protein Interaction Mapping, Receptors, Cell Surface, Sequence Alignment, Sequence Homology, Amino Acid, Species Specificity, Transfection, beta-Galactosidase, Clinical Sciences, Genetics & Heredity, Clinical sciences
Abstract

G(M1)-gangliosidosis is a lysosomal storage disorder caused by a deficiency of beta-galactosidase (GLB1). The GLB1 gene gives rise to the GLB1 lysosomal enzyme and to the elastin binding protein (EBP), involved in elastic fiber deposition. GLB1 forms a complex with protective protein cathepsin A (PPCA), alpha neuraminidase (NEU1), and galactosamine 6-sulphate sulfatase (GALNS) inside lysosomes, while EBP binds to PPCA and NEU1 on the cell surface. We investigated the function of the GLB1 and EBP mutated proteins by analyzing the clinical, genetic, and cellular data of 11 G(M1)-gangliosidosis patients. Their molecular analysis, followed by expression studies, lead to the identification of four new and 10 known GLB1 mutations. Some common amino acid substitutions [c.1445G>A (p.Arg482H), c.622C>T (p.Arg208His), c.175C>T (p.Arg59Cys) and c.176G>A (p.Arg59His)] were present in the GLB1 enzyme of several patients, all of Mediterranean origin, suggesting a common origin. Western blotting analyses against GLB1, EBP, and PPCA proteins showed that the identified mutations affect GLB1 enzyme activity and/or stability. The c.1445G>A (p.Arg482His), c.175C>T (p.Arg59Cys), c.733+2T>C, c.1736G>A (p.Gly579Asp), and c.1051C>T (p.Arg351X) GLB1 mutations, affect the stabilization of PPCA probably because they hamper the interaction between GLB1/EBP and PPCA within the multiprotein complex. The amount of EBP was normal, but the detection of impaired elastogenesis in such patients suggests an alteration in its function. We conclude that the presence of genetic lesions in both GLB1 and EBP coding region does not directly predict impaired elastogenesis and that elastic fiber assembly has to be evaluated specifically in each case. Nevertheless, the degree of EBP involvement may be linked to specific clinical findings.

Published
2005

17. Common and Novel TMEM70 Mutations in a Cohort of Italian Patients with Mitochondrial Encephalocardiomyopathy

Author

Diodato, Daria, Invernizzi, Federica, Lamantea, Eleonora, Fagiolari, Gigliola, Parini, Rossella, Menni, Francesca, Parenti, Giancarlo, Bollani, Lina, Pasquini, Elisabetta, Donati, Maria A., Cassandrini, Denise, Santorelli, Filippo M., Haack, Tobias B., Prokisch, Holger, Ghezzi, Daniele, Lamperti, Costanza, Zeviani, Massimo, Zschocke, Johannes, Editor-in-chief, Gibson, K Michael, Editor-in-chief, Gibson, K. Michael, editor, Brown, Garry, editor, Morava, Eva, editor, and Peters, Verena, editor

Published
2015
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21. Pre-diagnosing and managing patients with GM1 gangliosidosis and related disorders by the evaluation of GM1 ganglioside content

Author

Tonin, Rodolfo, Caciotti, Anna, Procopio, Elena, Fischetto, Rita, Deodato, Federica, Mancardi, Maria Margherita, Di Rocco, Maja, Ardissone, Anna, Salviati, Alessandro, Marangi, Antonio, Strisciuglio, Pietro, Mangone, Giusi, Casini, Arianna, Ricci, Silvia, Fiumara, Agata, Parini, Rossella, Pavone, Francesco Saverio, Guerrini, Renzo, Calamai, Martino, and Morrone, Amelia

Published
2019
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22. Long-term outcome of Hurler syndrome patients after hematopoietic cell transplantation: an international multicenter study

Author

Aldenhoven, Mieke, Wynn, Robert F., Orchard, Paul J., O’Meara, Anne, Veys, Paul, Fischer, Alain, Valayannopoulos, Vassili, Neven, Benedicte, Rovelli, Attilio, Prasad, Vinod K., Tolar, Jakub, Allewelt, Heather, Jones, Simon A., Parini, Rossella, Renard, Marleen, Bordon, Victoria, Wulffraat, Nico M., de Koning, Tom J., Shapiro, Elsa G., Kurtzberg, Joanne, and Boelens, Jaap Jan

Published
2015
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23. Recommendations on Reintroduction of Agalsidase Beta for Patients with Fabry Disease in Europe, Following a Period of Shortage

Author

Linthorst, Gabor E., Burlina, Alessandro P., Cecchi, Franco, Cox, Timothy M., Fletcher, Janice M., Feldt-Rasmussen, Ulla, Giugliani, Roberto, Hollak, Carla E. M., Houge, Gunnar, Hughes, Derralynn, Kantola, Iikka, Lachmann, Robin, Lopez, Monica, Ortiz, Alberto, Parini, Rossella, Rivera, Alberto, Rolfs, Arndt, Ramaswami, Uma, Svarstad, Einar, Tondel, Camilla, Tylki-Szymanska, Anna, Vujkovac, Bojan, Waldek, Steven, West, Michael, Weidemann, F., Mehta, Atul, Zschocke, Johannes, editor, Gibson, K Michael, editor, Brown, Garry, editor, Morava, Eva, editor, and Peters, Verena, editor

Published
2013
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27. A new case report of severe mucopolysaccharidosis type VII: diagnosis, treatment with haematopoietic cell transplantation and prenatal diagnosis in a second pregnancy

Author

Furlan, Francesca, Rovelli, Attilio, Rigoldi, Miriam, Filocamo, Mirella, Tappino, Barbara, Friday, Douglas, Gasperini, Serena, Mariani, Silvana, Izzi, Claudia, Bondioni, Maria Pia, Gellera, Cinzia, Venerando, Anna, Villa, Nicoletta, del Carmen Rodriguez Perez, Maria, Pavan, Fabio, Biondi, Andrea, and Parini, Rossella

Published
2018
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30. Clinical pattern, mutations and in vitro residual activity in 33 patients with severe 5, 10 methylenetetrahydrofolate reductase (MTHFR) deficiency

Author

Huemer, Martina, Mulder-Bleile, Regina, Burda, Patricie, Froese, D. Sean, Suormala, Terttu, Zeev, Bruria Ben, Chinnery, Patrick F., Dionisi-Vici, Carlo, Dobbelaere, Dries, Gökcay, Gülden, Demirkol, Mübeccel, Häberle, Johannes, Lossos, Alexander, Mengel, Eugen, Morris, Andrew A., Niezen-Koning, Klary E., Plecko, Barbara, Parini, Rossella, Rokicki, Dariusz, Schiff, Manuel, Schimmel, Mareike, Sewell, Adrian C., Sperl, Wolfgang, Spiekerkoetter, Ute, Steinmann, Beat, Taddeucci, Grazia, Trejo-Gabriel-Galán, Jose M., Trefz, Friedrich, Tsuji, Megumi, Vilaseca, María Antònia, von Kleist-Retzow, Jürgen-Christoph, Walker, Valerie, Zeman, Jiri, Baumgartner, Matthias R., and Fowler, Brian

Published
2016
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31. Proposal of an Algorithm to Early Detect Attenuated Type I Mucopolysaccharidosis (MPS Ia) among Children with Growth Abnormalities

Author

Baronio, F, Zucchini, S, Zulian, F, Salerno, M, Parini, R, Cattoni, A, Deodato, F, Gaeta, A, Bizzarri, C, Gasperini, S, Pession, A, Baronio, Federico, Zucchini, Stefano, Zulian, Francesco, Salerno, Mariacarolina, Parini, Rossella, Cattoni, Alessandro, Deodato, Federica, Gaeta, Alberto, Bizzarri, Carla, Gasperini, Serena, Pession, Andrea, Baronio, F, Zucchini, S, Zulian, F, Salerno, M, Parini, R, Cattoni, A, Deodato, F, Gaeta, A, Bizzarri, C, Gasperini, S, Pession, A, Baronio, Federico, Zucchini, Stefano, Zulian, Francesco, Salerno, Mariacarolina, Parini, Rossella, Cattoni, Alessandro, Deodato, Federica, Gaeta, Alberto, Bizzarri, Carla, Gasperini, Serena, and Pession, Andrea

Abstract

Background and Objectives: Diagnostic delay is common in attenuated Mucopolysaccharidosis Type I (MPS Ia) due to the rarity of the disease and the variability of clinical presentation. Short stature and impaired growth velocity are frequent findings in MPS Ia, but they rarely raise suspicion as paediatric endocrinologists are generally poorly trained to detect earlier and milder clinical signs of this condition. Materials and Methods: Following a consensus-based methodology, a multidisciplinary panel including paediatric endocrinologists, paediatricians with expertise in metabolic disorders, radiologists, and rheumatologists shared their experience on a possible clinical approach to the diagnosis of MPS Ia in children with short stature or stunted growth. Results: The result was the formation of an algorithm that illustrates how to raise the suspicion of MPS Ia in a patient older than 5 years with short stature and suggestive clinical signs. Conclusion: The proposed algorithm may represent a useful tool to improve the awareness of paediatric endocrinologists and reduce the diagnostic delay for patients with MPS Ia.

Published
2022

32. Evidence of treatment benefits in patients with MPSI-Hurler in long-term follow up using a new MRI scoring system

Author

Pontesilli, S, Baldoli, C, Della Rosa, P, Cattoni, A, Bernardo, M, Meregalli, P, Gasperini, S, Motta, S, Fumagalli, F, Tucci, F, Baciga, F, Consiglieri, G, Canonico, F, De Lorenzo, P, Chiapparini, L, Gentner, B, Aiuti, A, Biondi, A, Rovelli, A, Parini, R, Pontesilli, Silvia, Baldoli, Cristina, Della Rosa, Pasquale Anthony, Cattoni, Alessandro, Bernardo, Maria Ester, Meregalli, Pamela, Gasperini, Serena, Motta, Serena, Fumagalli, Francesca, Tucci, Francesca, Baciga, Federica, Consiglieri, Giulia, Canonico, Francesco, De Lorenzo, Paola, Chiapparini, Luisa, Gentner, Bernhard, Aiuti, Alessandro, Biondi, Andrea, Rovelli, Attilio, Parini, Rossella, Pontesilli, S, Baldoli, C, Della Rosa, P, Cattoni, A, Bernardo, M, Meregalli, P, Gasperini, S, Motta, S, Fumagalli, F, Tucci, F, Baciga, F, Consiglieri, G, Canonico, F, De Lorenzo, P, Chiapparini, L, Gentner, B, Aiuti, A, Biondi, A, Rovelli, A, Parini, R, Pontesilli, Silvia, Baldoli, Cristina, Della Rosa, Pasquale Anthony, Cattoni, Alessandro, Bernardo, Maria Ester, Meregalli, Pamela, Gasperini, Serena, Motta, Serena, Fumagalli, Francesca, Tucci, Francesca, Baciga, Federica, Consiglieri, Giulia, Canonico, Francesco, De Lorenzo, Paola, Chiapparini, Luisa, Gentner, Bernhard, Aiuti, Alessandro, Biondi, Andrea, Rovelli, Attilio, and Parini, Rossella

Abstract

We developed a brain and spine magnetic resonance scoring system based on a magnetic resonance assessment of 9 patients with mucopolysaccharidosis type I-Hurler who underwent hematopoietic stem-cell transplantation. The score is reliable and correlates with long-term clinical and cognitive outcome in patients with mucopolysaccharidosis type I-Hurler.

Published
2022

33. Evidence of treatment benefits in patients with MPSI-Hurler in long-term follow up using a new MRI scoring system

Author

Pontesilli, Silvia, Baldoli, Cristina, Della Rosa, Pasquale Anthony, Cattoni, Alessandro, Bernardo, Maria Ester, Meregalli, Pamela, Gasperini, Serena, Motta, Serena, Fumagalli, Francesca, Tucci, Francesca, Baciga, Federica, Consiglieri, Giulia, Canonico, Francesco, De Lorenzo, Paola, Chiapparini, Luisa, Gentner, Bernhard, Aiuti, Alessandro, Biondi, Andrea, Rovelli, Attilio, Parini, Rossella, Pontesilli, S, Baldoli, C, Della Rosa, P, Cattoni, A, Bernardo, M, Meregalli, P, Gasperini, S, Motta, S, Fumagalli, F, Tucci, F, Baciga, F, Consiglieri, G, Canonico, F, De Lorenzo, P, Chiapparini, L, Gentner, B, Aiuti, A, Biondi, A, Rovelli, A, and Parini, R

Subjects
magnetic resonance, MPSI, haematopoietic stem cell transplantation, HSCT, MPSI-H, ERT and MPS, neuroradiology and MPS
Abstract

We developed a brain and spine magnetic resonance scoring system based on a magnetic resonance assessment of 9 patients with mucopolysaccharidosis type I-Hurler who underwent hematopoietic stem-cell transplantation. The score is reliable and correlates with long-term clinical and cognitive outcome in patients with mucopolysaccharidosis type I-Hurler.

Published
2022

34. First-in-human phase I/II clinical trial of hematopoietic stem and progenitor cell gene therapy for Hurler syndrome: Favorable safety profile and extensive metabolic correction

Author

Tucci, Francesca, primary, Gentner, Bernhard, additional, Galimberti, Stefania, additional, Fumagalli, Francesca, additional, Consiglieri, Giulia, additional, Filisetti, Chiara, additional, Darin, Silvia, additional, Sarzana, Marina, additional, Scarparo, Stefano, additional, Ciotti, Francesca, additional, De Pellegrin, Maurizio, additional, Silvani, Paolo, additional, Baldoli, Cristina, additional, Pontesilli, Silvia, additional, Parini, Rossella, additional, Gasperini, Serena, additional, Serafini, Marta, additional, Rovelli, Attilio, additional, Forni, Giulia, additional, la Marca, Giancarlo, additional, Ciceri, Fabio, additional, Naldini, Luigi, additional, Aiuti, Alessandro, additional, and Bernardo, Maria Ester, additional

Published
2022
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35. Multicenter, non-interventional, double cohort study to assess the safety of alglucosidase alfa and laronidase in real-world home infusion setting

Author

Toscano, Antonio, primary, Scarpa, Maurizio, additional, Parini, Rossella, additional, Donati, Alice, additional, Crescimanno, Grazia, additional, Fiumara, Agata, additional, Fischetto, Rita, additional, Gasperini, Serena, additional, Siciliano, Gabriele, additional, Ravaglia, Sabrina, additional, Sechi, Annalisa, additional, Piperno, Alberto, additional, Cianci, Vittorio, additional, Maggi, Lorenzo, additional, Musumeci, Olimpia, additional, Taurisano, Roberta, additional, and Verrecchia, Elena, additional

Published
2022
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36. Effect of alglucosidase alfa dosage on survival and walking ability in patients with classic infantile Pompe disease: A multicentre observational follow-up study of the European Pompe Consortium

Author

Ditters, Imke A.M., primary, Huidekoper, Hidde H., additional, Kruijshaar, Michelle E., additional, Rizopoulos, Dimitris, additional, Hahn, Andreas, additional, Mongini, Tiziana E., additional, Labarthe, François, additional, Tardieu, Marine, additional, Chabrol, Brigitte, additional, Brassier, Anaïs, additional, Parini, Rossella, additional, Parenti, Giancarlo, additional, van der Beek, Nadine A.M.E., additional, van der Ploeg, Ans T., additional, and van den Hout, Hannerieke, additional

Published
2022
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37. Proposal of an Algorithm to Early Detect Attenuated Type I Mucopolysaccharidosis (MPS Ia) among Children with Growth Abnormalities

Author

Baronio, Federico, primary, Zucchini, Stefano, additional, Zulian, Francesco, additional, Salerno, Mariacarolina, additional, Parini, Rossella, additional, Cattoni, Alessandro, additional, Deodato, Federica, additional, Gaeta, Alberto, additional, Bizzarri, Carla, additional, Gasperini, Serena, additional, and Pession, Andrea, additional

Published
2022
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38. Evidence of Treatment Benefits in Patients with Mucopolysaccharidosis Type I-Hurler in Long-term Follow-up Using a New Magnetic Resonance Imaging Scoring System

Author

Pontesilli, Silvia, primary, Baldoli, Cristina, additional, Rosa, Pasquale Anthony Della, additional, Cattoni, Alessandro, additional, Bernardo, Maria Ester, additional, Meregalli, Pamela, additional, Gasperini, Serena, additional, Motta, Serena, additional, Fumagalli, Francesca, additional, Tucci, Francesca, additional, Baciga, Federica, additional, Consiglieri, Giulia, additional, Canonico, Francesco, additional, De Lorenzo, Paola, additional, Chiapparini, Luisa, additional, Gentner, Bernhard, additional, Aiuti, Alessandro, additional, Biondi, Andrea, additional, Rovelli, Attilio, additional, and Parini, Rossella, additional

Published
2022
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39. Effect of alglucosidase alfa dosage on survival and walking ability in patients with classic infantile Pompe disease: a multicentre observational cohort study from the European Pompe Consortium

Author

Ditters, Imke Anne Maartje, primary, Huidekoper, Hidde Harmen, additional, Kruijshaar, Michelle Elisabeth, additional, Rizopoulos, Dimitris, additional, Hahn, Andreas, additional, Mongini, Tiziana Enrica, additional, Labarthe, François, additional, Tardieu, Marine, additional, Chabrol, Brigitte, additional, Brassier, Anais, additional, Parini, Rossella, additional, Parenti, Giancarlo, additional, van der Beek, Nadine Anna Maria Elisabeth, additional, van der Ploeg, Ans Tjitske, additional, van den Hout, Johanna Maria Pieternel, additional, Mengel, Eugen, additional, Hennermann, Julia, additional, Smitka, Martin, additional, Muschol, Nicole, additional, Marquardt, Thorsten, additional, Marquardt, Martina, additional, Thiels, Charlotte, additional, Spada, Marco, additional, Pagliardini, Veronica, additional, Menni, Francesca, additional, della Casa, Roberto, additional, Deodato, Federica, additional, Gasperini, Serena, additional, Burlina, Alberto, additional, Donati, Alice, additional, Pichard, Samia, additional, Feillet, François, additional, Huet, Fréderic, additional, Mention, Karine, additional, Eyer, Didier, additional, Kuster, Alice, additional, Espil Taris, Caroline, additional, Lefranc, Jérémie, additional, Barth, Magalie, additional, Bruel, Henri, additional, Chevret, Laurent, additional, Pitelet, Gaele, additional, Pitelet, Catherine, additional, Rivier, François, additional, and Dobbelaere, Dries, additional

Published
2022
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40. Polymorphism in exercise genes and respiratory function in late-onset Pompe disease

Author

Ravaglia, Sabrina, primary, Malovini, Alberto, additional, Cirio, Serena, additional, Danesino, Cesare, additional, De Filippi, Paola, additional, Moggio, Maurizio, additional, Mongini, Tiziana, additional, Maggi, Lorenzo, additional, Servidei, Serena, additional, Vianello, Andrea, additional, Toscano, Antonio, additional, Tonin, Paola, additional, Maioli, Maria Antonietta, additional, Parini, Rossella, additional, Filosto, Massimiliano, additional, Crescimanno, Grazia, additional, Arceri, Sebastiano, additional, Piran, Manuela, additional, and Carlucci, Annalisa, additional

Published
2021
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42. Hematopoietic Stem- and Progenitor-Cell Gene Therapy for Hurler Syndrome

Author

Gentner, Bernhard, primary, Tucci, Francesca, additional, Galimberti, Stefania, additional, Fumagalli, Francesca, additional, De Pellegrin, Maurizio, additional, Silvani, Paolo, additional, Camesasca, Chiara, additional, Pontesilli, Silvia, additional, Darin, Silvia, additional, Ciotti, Francesca, additional, Sarzana, Marina, additional, Consiglieri, Giulia, additional, Filisetti, Chiara, additional, Forni, Giulia, additional, Passerini, Laura, additional, Tomasoni, Daniela, additional, Cesana, Daniela, additional, Calabria, Andrea, additional, Spinozzi, Giulio, additional, Cicalese, Maria-Pia, additional, Calbi, Valeria, additional, Migliavacca, Maddalena, additional, Barzaghi, Federica, additional, Ferrua, Francesca, additional, Gallo, Vera, additional, Miglietta, Simona, additional, Zonari, Erika, additional, Cheruku, Patali S., additional, Forni, Claudia, additional, Facchini, Marcella, additional, Corti, Ambra, additional, Gabaldo, Michela, additional, Zancan, Stefano, additional, Gasperini, Serena, additional, Rovelli, Attilio, additional, Boelens, Jaap-Jan, additional, Jones, Simon A., additional, Wynn, Robert, additional, Baldoli, Cristina, additional, Montini, Eugenio, additional, Gregori, Silvia, additional, Ciceri, Fabio, additional, Valsecchi, Maria G., additional, la Marca, Giancarlo, additional, Parini, Rossella, additional, Naldini, Luigi, additional, Aiuti, Alessandro, additional, and Bernardo, Maria-Ester, additional

Published
2021
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45. Optimizing the Molecular Diagnosis of GALNS: Novel Methods to Define and Characterize Morquio—A Syndrome-Associated Mutations

Author

Caciotti, Anna, Tonin, Rodolfo, Rigoldi, Miriam, Ferri, Lorenzo, Catarzi, Serena, Cavicchi, Catia, Procopio, Elena, Donati, Maria Alice, Ficcadenti, Anna, Fiumara, Agata, Barone, Rita, Garavelli, Livia, Di Rocco, Maja, Filocamo, Mirella, Antuzzi, Daniela, Scarpa, Maurizio, Mooney, Sean D., Li, Biao, Skouma, Anastasia, Bianca, Sebastiano, Concolino, Daniela, Casalone, Rosario, Monti, Elena, Pantaleo, Marilena, Giglio, Sabrina, Guerrini, Renzo, Parini, Rossella, and Morrone, Amelia

Published
2015
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47. Common and Novel TMEM70 Mutations in a Cohort of Italian Patients with Mitochondrial Encephalocardiomyopathy

Author

Diodato, Daria, primary, Invernizzi, Federica, additional, Lamantea, Eleonora, additional, Fagiolari, Gigliola, additional, Parini, Rossella, additional, Menni, Francesca, additional, Parenti, Giancarlo, additional, Bollani, Lina, additional, Pasquini, Elisabetta, additional, Donati, Maria A., additional, Cassandrini, Denise, additional, Santorelli, Filippo M., additional, Haack, Tobias B., additional, Prokisch, Holger, additional, Ghezzi, Daniele, additional, Lamperti, Costanza, additional, and Zeviani, Massimo, additional

Published
2014
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49. Hematopoietic Stem- and Progenitor-Cell Gene Therapy for Hurler Syndrome

Author

Gentner, B, Tucci, F, Galimberti, S, Fumagalli, F, De Pellegrin, M, Silvani, P, Camesasca, C, Pontesilli, S, Darin, S, Ciotti, F, Sarzana, M, Consiglieri, G, Filisetti, C, Forni, G, Passerini, L, Tomasoni, D, Cesana, D, Calabria, A, Spinozzi, G, Cicalese, M, Calbi, V, Migliavacca, M, Barzaghi, F, Ferrua, F, Gallo, V, Miglietta, S, Zonari, E, Cheruku, P, Forni, C, Facchini, M, Corti, A, Gabaldo, M, Zancan, S, Gasperini, S, Rovelli, A, Boelens, J, Jones, S, Wynn, R, Baldoli, C, Montini, E, Gregori, S, Ciceri, F, Valsecchi, M, la Marca, G, Parini, R, Naldini, L, Aiuti, A, Bernardo, M, Gentner, Bernhard, Tucci, Francesca, Galimberti, Stefania, Fumagalli, Francesca, De Pellegrin, Maurizio, Silvani, Paolo, Camesasca, Chiara, Pontesilli, Silvia, Darin, Silvia, Ciotti, Francesca, Sarzana, Marina, Consiglieri, Giulia, Filisetti, Chiara, Forni, Giulia, Passerini, Laura, Tomasoni, Daniela, Cesana, Daniela, Calabria, Andrea, Spinozzi, Giulio, Cicalese, Maria-Pia, Calbi, Valeria, Migliavacca, Maddalena, Barzaghi, Federica, Ferrua, Francesca, Gallo, Vera, Miglietta, Simona, Zonari, Erika, Cheruku, Patali S, Forni, Claudia, Facchini, Marcella, Corti, Ambra, Gabaldo, Michela, Zancan, Stefano, Gasperini, Serena, Rovelli, Attilio, Boelens, Jaap-Jan, Jones, Simon A, Wynn, Robert, Baldoli, Cristina, Montini, Eugenio, Gregori, Silvia, Ciceri, Fabio, Valsecchi, Maria G, la Marca, Giancarlo, Parini, Rossella, Naldini, Luigi, Aiuti, Alessandro, Bernardo, Maria-Ester, Gentner, B, Tucci, F, Galimberti, S, Fumagalli, F, De Pellegrin, M, Silvani, P, Camesasca, C, Pontesilli, S, Darin, S, Ciotti, F, Sarzana, M, Consiglieri, G, Filisetti, C, Forni, G, Passerini, L, Tomasoni, D, Cesana, D, Calabria, A, Spinozzi, G, Cicalese, M, Calbi, V, Migliavacca, M, Barzaghi, F, Ferrua, F, Gallo, V, Miglietta, S, Zonari, E, Cheruku, P, Forni, C, Facchini, M, Corti, A, Gabaldo, M, Zancan, S, Gasperini, S, Rovelli, A, Boelens, J, Jones, S, Wynn, R, Baldoli, C, Montini, E, Gregori, S, Ciceri, F, Valsecchi, M, la Marca, G, Parini, R, Naldini, L, Aiuti, A, Bernardo, M, Gentner, Bernhard, Tucci, Francesca, Galimberti, Stefania, Fumagalli, Francesca, De Pellegrin, Maurizio, Silvani, Paolo, Camesasca, Chiara, Pontesilli, Silvia, Darin, Silvia, Ciotti, Francesca, Sarzana, Marina, Consiglieri, Giulia, Filisetti, Chiara, Forni, Giulia, Passerini, Laura, Tomasoni, Daniela, Cesana, Daniela, Calabria, Andrea, Spinozzi, Giulio, Cicalese, Maria-Pia, Calbi, Valeria, Migliavacca, Maddalena, Barzaghi, Federica, Ferrua, Francesca, Gallo, Vera, Miglietta, Simona, Zonari, Erika, Cheruku, Patali S, Forni, Claudia, Facchini, Marcella, Corti, Ambra, Gabaldo, Michela, Zancan, Stefano, Gasperini, Serena, Rovelli, Attilio, Boelens, Jaap-Jan, Jones, Simon A, Wynn, Robert, Baldoli, Cristina, Montini, Eugenio, Gregori, Silvia, Ciceri, Fabio, Valsecchi, Maria G, la Marca, Giancarlo, Parini, Rossella, Naldini, Luigi, Aiuti, Alessandro, and Bernardo, Maria-Ester

Abstract

Background Allogeneic hematopoietic stem-cell transplantation is the standard of care for Hurler syndrome (mucopolysaccharidosis type I, Hurler variant [MPSIH]). However, this treatment is only partially curative and is associated with complications. Methods We are conducting an ongoing study involving eight children with MPSIH. At enrollment, the children lacked a suitable allogeneic donor and had a Developmental Quotient or Intelligence Quotient score above 70 (i.e., none had moderate or severe cognitive impairment). The children received autologous hematopoietic stem and progenitor cells (HSPCs) transduced ex vivo with an alpha-L-iduronidase (IDUA)-encoding lentiviral vector after myeloablative conditioning. Safety and correction of blood IDUA activity up to supraphysiologic levels were the primary end points. Clearance of lysosomal storage material as well as skeletal and neurophysiological development were assessed as secondary and exploratory end points. The planned duration of the study is 5 years. Results We now report interim results. The children's mean (+/- SD) age at the time of HSPC gene therapy was 1.9 +/- 0.5 years. At a median follow-up of 2.10 years, the procedure had a safety profile similar to that known for autologous hematopoietic stem-cell transplantation. All the patients showed prompt and sustained engraftment of gene-corrected cells and had supraphysiologic blood IDUA activity within a month, which was maintained up to the latest follow-up. Urinary glycosaminoglycan (GAG) excretion decreased steeply, reaching normal levels at 12 months in four of five patients who could be evaluated. Previously undetectable levels of IDUA activity in the cerebrospinal fluid became detectable after gene therapy and were associated with local clearance of GAGs. Patients showed stable cognitive performance, stable motor skills corresponding to continued motor development, improved or stable findings on magnetic resonance imaging of the brain and spine, reduced

Published
2021

50. Brain and spine MRI features of Hunter disease: frequency, natural evolution and response to therapy

Author

Manara, Renzo, Priante, Elena, Grimaldi, Marco, Santoro, Lucia, Astarita, Luca, Barone, Rita, Concolino, Daniela, Di Rocco, Maja, Donati, Maria Alice, Fecarotta, Simona, Ficcadenti, Anna, Fiumara, Agata, Furlan, Francesca, Giovannini, Irene, Lilliu, Franco, Mardari, Rodica, Polonara, Gabriele, Procopio, Elena, Rampazzo, Angelica, Rossi, Andrea, Sanna, Graziolina, Parini, Rossella, and Scarpa, Maurizio

Published
2011
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