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2. Using CD4 percentage and age to optimize pediatric antiretroviral therapy initiation

Author

Yin, D.E., Warshaw, M.G., Miller, W.C., Castro, H., Fiscus, S.A., Harper, L.M., Harrison, L.J., Klein, N.J., Lewis, J., Melvin, A.J., Tudor Williams, G., Mckinney, R.E., Brouwers, P., Costello, D., Ferguson, E., Fiscus, S., Hodge, J., Hughes, M., Jennings, C., Melvin, A., Mckinney, R., Mofenson, L., Warshaw, M., Smith, M., Spector, S., Stiehm, E., Toye, M., Yogev, R., Babiker, A., Compagnucci, A., De Rossi, A., Giaquinto, C., Darbyshire, J., Debré, M., Gibb, D., Harper, L., Harrison, L., Klein, N., Pillay, D., Saidi, Y., Walker, A., Brody, B., Hill, C., Lepage, P., Modlin, J., Poziak, A., Rein, M., Robb, M., Fleming, T., Vella, S., Kim, K., Bologna, R., Mecikovsky, D., Pineda, N., Sen, L., Mangano, A., Marino, S., Galvez, C., Deluchi, G., Zöhrer, B., Zenz, W., Daghofer, E., Pfurtscheller, K., Pabst, B., Gomez, M., Mcneil, P., Jervis, M., Whyms, I., Kwolfe, D., Scott, S., Mussi Pinhata MM, Issac, M., Cervi, M., Negrini, B., Matsubara, T., de Souza CB, Gabaldi, J., Oliveira, R., Sapia, M., Abreu, T., Evangelista, L., Pala, A., Fernandes, I., Farias, I., Melo M, D.F., Carreira, H., Lira, L., Della Negra, M., Queiroz, W., Lian, Y., Pacola, D., Pinto, J., Ferreira, F., Kakehasi, F., Martins, L., Diniz, A., Lobato, V., Diniz, M., Cleto, S., Costa, S., Romeiro, J., Dollfus, C., Tabone, M., Courcoux, M., Vaudre, G., Dehée, A., Schnuriger, A., Le Gueyades, N., De Bortoli, C., Méchinaud, F., Reliquet, V., Arias, J., Rodallec, A., André, E., Falconi, I., Le Pelletier, A., Monpoux, F., Cottalorda, J., Mellul, S., Lachassinne, E., Galimand, J., Rouzioux, C., Chaix, M., Benabadji, Z., Pourrat, M., Firtion, G., Rivaux, D., Denon, M., Boudjoudi, N., Nganzali, F., Krivine, A., Méritet, J., Delommois, G., Norgeux, C., Guérin, C., Floch, C., Marty, L., Hichou, H., Tournier, V., Faye, A., Le Moal, I., Sellier, M., Dehache, L., Damond, F., Leleu, J., Beniken, D., Alexandre Castor, G., Neubert, J., Niehues, T., Laws, H., Huck, K., Gudowius, S., Siepermann, K., Loeffler, H., Bellert, S., Ortwin, A., Notheis, G., Wintergerst, U., Hoffman, F., Werthmann, A., Seyboldt, S., Schneider, L., Bucholz, B., Feiterna Sperling, C., Peiser, C., Nickel, R., Schmitz, T., Piening, T., Müller, C., Warncke, G., Wigger, M., Neubauer, R., Butler, K., Chong, A., Boulger, T., Menon, A., O'Connell, M., Barrett, L., Rochford, A., Goode, M., Hayes, E., Mcdonagh, S., Walsh, A., Doyle, A., Fanning, J., O'Connor, M., Byrne, M., O'Sullivan, N., Hyland, E., Giacomet, V., Viganò, A., Colombo, I., Trabattoni, D., Berzi, A., Badolato, R., Schumacher, F., Bennato, V., Brusati, M., Sorlini, A., Spinelli, E., Filisetti, M., Bertulli, C., Rampon, O., Zanchetta, M., Mazza, A., Stringari, G., Rossetti, G., Bernardi, S., Martino, A., Castelli Gattinara, G., Palma, P., Pontrelli, G., Tchidjou, H., Furcas, A., Frillici, C., Mazzei, A., Zoccano, A., Concato, C., Duiculescu, D., Oprea, C., Tardei, G., Abaab, F., Mardarescu, M., Draghicenoiu, R., Otelea, D., Alecsandru, L., Matusa, R., Rugina, S., Ilie, M., Netescu, S., Florea, C., Voicu, E., Poalelungi, D., Belmega, C., Vladau, L., Chiriac, A., Ramos Amador JT, Gonzalez Tomé MI, Rojo Conejo, P., Fernandez, M., Delgado Garcia, R., Ferrari, J., Garcia Lopez, M., Mellado Peña MJ, Martin Fontelos, P., Jimenez Nacher, I., Muñoz Fernandez MA, Jimenez, J., García Torre, A., Penin, M., Pineiro Perez, R., Garcia Mellado, I., Finn, A., Lajeunesse, M., Hutchison, E., Usher, J., Ball, L., Dunn, M., Sharland, M., Doerholt, K., Storey, S., Donaghy, S., Chakraborty, R., Wells, C., Buckberry, K., Rice, P., Mcmaster, P., Butler, P., O'Connell C, R., Shenton, J., Haley, H., Orendi, J., Stroobant, J., Navarante, L., Archer, P., Mazhude, C., Scott, D., O'Connell, R., Wong, J., Boddy, G., Shackley, F., Lakshman, R., Hobbs, J., Ball, G., Kudesia, G., Bane, J., Painter, D., Sloper, K., Shah, V., Cheng, A., Aali, A., Ball, C., Hawkins, S., Nayagam, D., Waters, A., Doshi, S., Liebeschuetz, S., Sodiende, B., Shingadia, D., Wong, S., Swan, J., Shah, Z., Collinson, A., Hayes, C., King, J., O'Connor, K., Lyall, H., Fidler, K., Walters, S., Foster, C., Hamadache, D., Newbould, C., Monrose, C., Campbell, S., Yeung, S., Cohen, J., Martinez Allier, N., Melvin, D., Dodge, J., Welch, S., Tatum, G., Gordon, A., Kaye, S., Muir, D., Patel, D., Novelli, V., Moshal, K., Lambert, J., Flynn, J., Farrelly, L., Clapson, M., Spencer, L., Depala, M., Jacobsen, M., Segal, S., Pollard, A., Kelly, D., Yeadon, S., Ohene Kena, B., Peng, Y., Dong, T., Jeffries, K., Snelling, M., Smyth, A., Smith, J., Ward, B., Jungmann, E., Ryan, C., Swaby, K., Buckton, A., Smit, E., Abrams, E., Champion, S., Fernandez, A., Calo, D., Garrovillo, L., Swaminathan, K., Alford, T., Frere, M., Navarra, J., Borkowsky, W., Deygoo, S., Hastings, T., Akleh, S., Ilmet, T., Mohan, K., Bowen, G., Emmanuel, P., Lujan Zimmerman, J., Rodriguez, C., Johnson, S., Marion, A., Graisbery, C., Casey, D., Lewis, G., Guzman Cottrill, J., Croteau, R., Acevedo Flores, M., Gonzalez, M., Angeli, L., Fabregas, L., Valentin, P., Weiner, L., Contello, K., Holz, W., Butler, M., Nachman, S., Kelly, M., Ferraro, D., Rana, S., Reed, C., Yeagley, E., Malheiro, A., Roa, J., Neely, M., Kovacs, A., Homans, J., Rodriguez Lozano, Y., Puga, A., Talero, G., Sellers, R., Lawrence, R., Weinberg, G., Murante, B., Laverty, S., Deveikis, A., Batra, J., Chen, T., Michalik, D., Deville, J., Elkins, K., Marks, S., Jackson Alvarez, J., Palm, J., Fineanganofo, I., Keuth, M., Deveikis, L., Tomosada, W., Van Dyke, R., Alchediak, T., Silio, M., Borne, C., Bradford, S., Eloby Childress, S., Nguyen, K., Rathore, M., Alvarez, A., Mirza, A., Mahmoudi, S., Burke, M., Febo, I., Lugo, L., Santos, R., Church, J., Dunaway, T., Rodier, C., Flynn, P., Patel, N., Discenza, S., Donohoe, M., Luzuriaga, K., Picard, D., Kline, M., Paul, M., Shearer, W., Mcmullen, C., Chadwick, E., Cagwin, E., Kabat, K., Dieudonne, A., Palumbo, P., Johnson, J., Gaur, S., Cerracchio, L., Foca, M., Jurgrau, A., Vasquez Bonilla, S., Silva, G., Gershon, A., Sullivan, J., Bryson, Y., Frenkel, L., Nelson, J., Aboulker, J., Hadjou, G., Léonardo, S., Riault, Y., Saïdi, Y., Buck, L., Forcat, S., Horton, J., Johnson, D., Moore, S., Taylor, C., Collins, D., Buskirk, S., Kamara, P., Nesel, C., Johnson, M., Ferreira, A., Tutko, J., Sprenger, H., Britto, P., Powell, C., Dersimonian, R., Handelsman, E., Ananworanich, J., Belfrage, E., Blanche, S., Bohlin, A., Burger, D., Clayden, P., De Groot, R., Di Biagio, A., Grosch Wörner, I., Hainault, M., Lallemant, M., Levy, J., Marczynska, M., Mellado Pena MJ, Nadal, D., Naver, L., Peckham, C., Popieska, J., Rosado, L., Rosso, R., Rudin, C., Scherpbier, H., Stevanovic, M., Thorne, C., Tovo, P., Valerius, N., Poole, C., Cole, S., and Mcculloh, R.J.

Subjects
CD4-Positive T-Lymphocytes, Male, medicine.medical_treatment, HIV (FISIOLOGIA), lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, Treatment failure, Settore BIO/13 - Biologia Applicata, Antiretroviral Therapy, Highly Active, immunologic, Child, HIV, child, reconstitution, treatment failure, Adolescent, Anti-HIV Agents, CD4 Lymphocyte Count, Child, Preschool, Female, Follow-Up Studies, HIV-1, Humans, Infant, Infant, Newborn, Follow up studies, Immunosuppression, medicine.medical_specialty, Settore MED/17 - Malattie Infettive, Antiretroviral Therapy, World health, Article, Internal medicine, medicine, Highly Active, Preschool, Settore MED/04 - Patologia Generale, business.industry, Disease progression, Settore MED/46 - Scienze Tecniche di Medicina di Laboratorio, Newborn, Antiretroviral therapy, Confidence interval, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Immunologic, Reconstitution, Pediatrics, Perinatology and Child Health, Immunology, business
Abstract

BACKGROUND: Quantifying pediatric immunologic recovery by highly active antiretroviral therapy (HAART) initiation at different CD4 percentage (CD4%) and age thresholds may inform decisions about timing of treatment initiation. METHODS: HIV-1-infected, HAART-naive children in Europe and the Americas were followed from 2002 through 2009 in PENPACT-1. Data from 162 vertically infected children, with at least World Health Organization “mild” immunosuppression and CD4% RESULTS: Seventy-two percent of baseline immunosuppressed children recovered to normal within 4 years. Compared with “severe” immunosuppression, more children with “mild” immunosuppression (difference 36%, 95% confidence interval [CI]: 22% to 49%) or “advanced” immunosuppression (difference 20.8%, 95% CI: 5.8% to 35.9%) recovered a normal CD4%. For each 5-year increase in baseline age, the proportion of children achieving a normal CD4% declined by 19% (95% CI: 11% to 27%). Combining baseline CD4% and age effects resulted in >90% recovery when initiating HAART with “mild” immunosuppression at any age or “advanced” immunosuppression at age CONCLUSIONS: Initiating HAART at higher CD4% and younger ages maximizes potential for immunologic recovery. Guidelines should weigh immunologic benefits against long-term risks.

Published
2014

5. 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 MP, Calbi V, Migliavacca M, Barzaghi F, Ferrua F, Gallo V, Miglietta S, Zonari E, Cheruku PS, Forni C, Facchini M, Corti A, Gabaldo M, Zancan S, Gasperini S, Rovelli A, Boelens JJ, Jones SA, Wynn R, Baldoli C, Montini E, Gregori S, Ciceri F, Valsecchi MG, la Marca G, Parini R, Naldini L, Aiuti A, and Bernardo ME

Subjects
Child, Preschool, Female, Follow-Up Studies, Genetic Vectors, Glycosaminoglycans urine, Humans, Iduronidase deficiency, Iduronidase genetics, Infant, Lentivirus, Male, Mucopolysaccharidosis I metabolism, Mutation, Stem Cell Transplantation, Transplantation, Autologous, Genetic Therapy, Hematopoietic Stem Cell Transplantation, Iduronidase metabolism, Mucopolysaccharidosis I therapy
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 α-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 joint stiffness, and normal growth in line with World Health Organization growth charts., Conclusions: The delivery of HSPC gene therapy in patients with MPSIH resulted in extensive metabolic correction in peripheral tissues and the central nervous system. (Funded by Fondazione Telethon and others; ClinicalTrials.gov number, NCT03488394; EudraCT number, 2017-002430-23.)., (Copyright © 2021 Massachusetts Medical Society.)

Published
2021
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6. Positional plagiocephaly from structure to function: Clinical experience of the service of pediatric osteopathy in Italy.

Author

Filisetti M, Cattarelli D, and Bonomi S

Subjects
Developmental Disabilities etiology, Female, Gastrointestinal Diseases etiology, Humans, Infant, Infant, Newborn, Italy, Male, Neurologic Examination, Treatment Outcome, Osteopathic Medicine methods, Plagiocephaly complications, Plagiocephaly therapy
Abstract

Objective: Aim of the study is to evaluate disorders related to positional plagiocephaly and introduce a new model of early intervention based on the osteopathic integrated approach., Methods: We review clinical experience of the "Program for Neurodevelopmental Follow-up and Pediatric Osteopathy", a service dedicated to newborns at risk for developmental disorders., Results: We present clinical data of 310 newborns followed during first years of life. Data analysis examines perinatal history, general features and disorders that could be related to plagiocephaly., Conclusions: The experience confirms that plagiocephaly is not only a problem regarding the shape of the head, it involves the functions. In our Service most babies (81%) with positional plagiocephaly showed isolated or associated disorders that had an impact on growth, behavior and development. The early intervention based on the osteopathic integrated approach is addressed not only to the cranial shape but consider the baby as a whole, and the environment where he lives., Competing Interests: Declaration of competing interest The authors have no conflicts of interest relevant to this article to disclose., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2020
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