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2. First clinical application of cord blood mesenchymal stromal cells in children with multi-drug resistant nephrotic syndrome

Author

Morello, William, Budelli, Silvia, Bernstein, Daniel Ari, Montemurro, Tiziana, Montelatici, Elisa, Lavazza, Cristiana, Ghio, Luciana, Edefonti, Alberto, Peruzzi, Licia, Molino, Daniela, Benetti, Elisa, Gianoglio, Bruno, Mehmeti, Florian, Catenacci, Laura, Rotella, Jessica, Tamburello, Chiara, Moretta, Antonia, Lazzari, Lorenza, Giordano, Rosaria, Prati, Daniele, and Montini, Giovanni

Published
2022
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3. Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product

Author

Lavazza, Cristiana, Budelli, Silvia, Montelatici, Elisa, Viganò, Mariele, Ulbar, Francesca, Catani, Lucia, Cannone, Marta Giulia, Savelli, Sara, Groppelli, Elisa, Lazzari, Lorenza, Lemoli, Roberto M., Cescon, Matteo, La Manna, Gaetano, Giordano, Rosaria, and Montemurro, Tiziana

Published
2022
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6. Feasibility and safety of treating non-unions in tibia, femur and humerus with autologous, expanded, bone marrow-derived mesenchymal stromal cells associated with biphasic calcium phosphate biomaterials in a multicentric, non-comparative trial

Author

Gómez-Barrena, Enrique, Rosset, Philippe, Gebhard, Florian, Hernigou, Philippe, Baldini, Nicola, Rouard, Helène, Sensebé, Luc, Gonzalo-Daganzo, Rosa M., Giordano, Rosaria, Padilla-Eguiluz, Norma, García-Rey, Eduardo, Cordero-Ampuero, José, Rubio-Suárez, Juan Carlos, Stanovici, Julien, Ehrnthaller, Christian, Huber-Lang, Markus, Flouzat-Lachaniette, Charles Henri, Chevallier, Nathalie, Donati, Davide Maria, Ciapetti, Gabriela, Fleury, Sandrine, Fernandez, Manuel-Nicolás, Cabrera, José-Rafael, Avendaño-Solá, Cristina, Montemurro, Tiziana, Panaitescu, Carmen, Veronesi, Elena, Rojewski, Markus Thomas, Lotfi, Ramin, Dominici, Massimo, Schrezenmeier, Hubert, and Layrolle, Pierre

Published
2019
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7. Off-the-Shelf Cord-Blood Mesenchymal Stromal Cells: Production, Quality Control, and Clinical Use.

Author

Montemurro, Tiziana, Lavazza, Cristiana, Montelatici, Elisa, Budelli, Silvia, La Rosa, Salvatore, Barilani, Mario, Mei, Cecilia, Manzini, Paolo, Ratti, Ilaria, Cimoni, Silvia, Brasca, Manuela, Prati, Daniele, Saporiti, Giorgia, Astori, Giuseppe, Elice, Francesca, Giordano, Rosaria, and Lazzari, Lorenza

Subjects
STROMAL cells, QUALITY control, DYSPLASIA, CURRENT good manufacturing practices, CORD blood, MANUFACTURING processes
Abstract

Background Recently, mesenchymal stromal cells (MSCs) have gained recognition for their clinical utility in transplantation to induce tolerance and to improve/replace pharmacological immunosuppression. Cord blood (CB)-derived MSCs are particularly attractive for their immunological naivety and peculiar anti-inflammatory and anti-apoptotic properties. Objectives: The objective of this study was to obtain an inventory of CB MSCs able to support large-scale advanced therapy medicinal product (ATMP)-based clinical trials. Study design: We isolated MSCs by plastic adherence in a GMP-compliant culture system. We established a well-characterized master cell bank and expanded a working cell bank to generate batches of finished MSC(CB) products certified for clinical use. The MSC(CB) produced by our facility was used in approved clinical trials or for therapeutic use, following single-patient authorization as an immune-suppressant agent. Results: We show the feasibility of a well-defined MSC manufacturing process and describe the main indications for which the MSCs were employed. We delve into a regulatory framework governing advanced therapy medicinal products (ATMPs), emphasizing the need of stringent quality control and safety assessments. From March 2012 to June 2023, 263 of our Good Manufacturing Practice (GMP)-certified MSC(CB) preparations were administered as ATMPs in 40 subjects affected by Graft-vs.-Host Disease, nephrotic syndrome, or bronco-pulmonary dysplasia of the newborn. There was no infusion-related adverse event. No patient experienced any grade toxicity. Encouraging preliminary outcome results were reported. Clinical response was registered in the majority of patients treated under therapeutic use authorization. Conclusions: Our 10 years of experience with MSC(CB) described here provides valuable insights into the use of this innovative cell product in immune-mediated diseases. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Molecular and functional characterization of CD133+ stem/progenitor cells infused in patients with end-stage liver disease reveals their interplay with stromal liver cells

Author

Catani, Lucia, Sollazzo, Daria, Bianchi, Elisa, Ciciarello, Marilena, Antoniani, Chiara, Foscoli, Licia, Caraceni, Paolo, Giannone, Ferdinando Antonino, Baldassarre, Maurizio, Giordano, Rosaria, Montemurro, Tiziana, Montelatici, Elisa, D'Errico, Antonia, Andreone, Pietro, Giudice, Valeria, Curti, Antonio, Manfredini, Rossella, and Lemoli, Roberto Massimo

Published
2017
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11. Regulatory T cells from patients with end-stage organ disease can be isolated, expanded and cryopreserved according good manufacturing practice improving their function

Author

Ulbar, Francesca, Montemurro, Tiziana, Jofra, Tatiana, Capri, Miriam, Comai, Giorgia, Bertuzzo, Valentina, Lavazza, Cristiana, Mandelli, Alessandra, Viganò, Mariele, Budelli, Silvia, Bacalini, Maria Giulia, Pirazzini, Chiara, Garagnani, Paolo, Giudice, Valeria, Sollazzo, Daria, Curti, Antonio, Arpinati, Mario, La Manna, Gaetano, Cescon, Matteo, Pinna, Antonio Daniele, Franceschi, Claudio, Battaglia, Manuela, Giordano, Rosaria, Catani, Lucia, and Lemoli, Roberto Massimo

Published
2019
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13. A virtual reality craving study in tobacco addiction: The role of non-pharmacological support in tobacco detox therapy

Author

Zamboni, Lorenzo, primary, Campagnari, Simone, additional, Giordano, Rosaria, additional, Fusina, Francesca, additional, Carli, Silvia, additional, Congiu, Alessio, additional, Barbon, Isabella, additional, Melchiori, Silvia, additional, Casari, Rebecca, additional, Tedeschi, Elisa, additional, Vesentin, Roberta, additional, Verlato, Giuseppe, additional, Infante, Maurizio Valentino, additional, and Lugoboni, Fabio, additional

Published
2022
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16. Additional file 1 of First clinical application of cord blood mesenchymal stromal cells in children with multi-drug resistant nephrotic syndrome

Author

Morello, William, Budelli, Silvia, Bernstein, Daniel Ari, Montemurro, Tiziana, Montelatici, Elisa, Lavazza, Cristiana, Ghio, Luciana, Edefonti, Alberto, Peruzzi, Licia, Molino, Daniela, Benetti, Elisa, Gianoglio, Bruno, Mehmeti, Florian, Catenacci, Laura, Rotella, Jessica, Tamburello, Chiara, Moretta, Antonia, Lazzari, Lorenza, Giordano, Rosaria, Prati, Daniele, and Montini, Giovanni

Abstract

Additional file 1: Table S1. Additional clinical information of enrolled patients. Table S2. CB MSC dose and quality per patient. Table S3. CB MSC dose and quality.

Published
2022
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17. Additional file 1 of Factors associated with a change in smoking habit during the first COVID-19 lockdown: an Italian cross-sectional study among ever-smokers

Author

Munarini, Elena, Stival, Chiara, Boffi, Roberto, Lugoboni, Fabio, Veronese, Chiara, Tinghino, Biagio, Agnelli, Gianna Maria, Lugo, Alessandra, Gallus, Silvano, and Giordano, Rosaria

Abstract

Additional file 1: Table S1. Distribution of the 416* current smokers before lockdown (multinomial logistic regression analysis). Table S2. Distribution of the 441 current smokers* during lockdown according to their desire to quit smoking.

Published
2022
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18. Additional file 1 of Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product

Author

Lavazza, Cristiana, Budelli, Silvia, Montelatici, Elisa, Vigan��, Mariele, Ulbar, Francesca, Catani, Lucia, Cannone, Marta Giulia, Savelli, Sara, Groppelli, Elisa, Lazzari, Lorenza, Lemoli, Roberto M., Cescon, Matteo, La Manna, Gaetano, Giordano, Rosaria, and Montemurro, Tiziana

Abstract

Additional file 1. Supplementary table 1. Criticality matrices for PHA. Supplementary table 2. Multicolor flow cytometry for investigational medicinal product characterization: type and quantity of antibodies per assessment. Supplementary figure 1. Negative control for FoxP3 staining

Published
2022
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19. Safety and Effectiveness of Cell Therapy in Neurodegenerative Diseases: Take-Home Messages From a Pilot Feasibility Phase I Study of Progressive Supranuclear Palsy

Author

Giordano, Rosaria, primary, Canesi, Margherita, additional, Isalberti, Maurizio, additional, Marfia, Giovanni, additional, Campanella, Rolando, additional, Vincenti, Daniele, additional, Cereda, Viviana, additional, Ranghetti, Alessandra, additional, Palmisano, Chiara, additional, Isaias, Ioannis Ugo, additional, Benti, Riccardo, additional, Marotta, Giorgio, additional, Lazzari, Lorenza, additional, Montemurro, Tiziana, additional, Viganò, Mariele, additional, Budelli, Silvia, additional, Montelatici, Elisa, additional, Lavazza, Cristiana, additional, Rivera-Ordaz, Araceli, additional, and Pezzoli, Gianni, additional

Published
2021
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20. Osteonecrosis of the femoral head safely healed with autologous, expanded, bone marrow-derived mesenchymal stromal cells in a multicentric trial with minimum 5 years follow-up

Author

Gómez-Barrena, Enrique, Padilla-Eguiluz, Norma G., Rosset, Philippe, Hernigou, Philippe, Baldini, Nicola, Ciapetti, Gabriela, Gonzalo-Daganzo, Rosa M., Avendaño-Solá, Cristina, Rouard, Hélène, Giordano, Rosaria, Dominici, Massimo, Schrezenmeier, Hubert, Layrolle, Pierre, REBORNE Consortium, UAM. Departamento de Cirugía, Instituto de Investigación Sanitaria Hospital Universitario de La Paz (IdiPAZ), Gomez-Barrena E., Padilla-Eguiluz N.G., Rosset P., Hernigou P., Baldini N., Ciapetti G., Gonzalo-Daganzo R.M., Avendano-Sola C., Rouard H., Giordano R., Dominici M., Schrezenmeier H., and Layrolle P.

Subjects
medicine.medical_specialty, Medicina, lcsh:Medicine, Article, 03 medical and health sciences, Femoral head, 0302 clinical medicine, bone regeneration, medicine, In patient, ddc:610, Bone regeneration, Adverse effect, 030304 developmental biology, 030222 orthopedics, 0303 health sciences, business.industry, Mesenchymal stem cell, lcsh:R, clinical trial, General Medicine, Surgery, Clinical trial, medicine.anatomical_structure, femoral head osteonecrosis, Total dose, expanded MSC, Bone marrow, business, DDC 610 / Medicine & health
Abstract

Background: Osteonecrosis (ON) of the femoral head represents a potentially severe disease of the hip where the lack of bone regeneration may lead to femoral head collapse and secondary osteoarthritis, with serious pain and disability. The aim of this European, multicentric clinical trial was to prove safety and early efficacy to heal early femoral head ON in patients through minimally invasive surgical implantation of autologous mesenchymal stromal cells (MSC) expanded from bone marrow (BM) under good manufacturing practices (GMP). Methods: Twenty-two patients with femoral head ON (up to ARCO 2C) were recruited and surgically treated in France, Germany, Italy and Spain with BM-derived, expanded autologous MSC (total dose 140 million MSC in 7 mL). The investigational advanced therapy medicinal product (ATMP) was expanded from BM under the same protocol in all four countries and approved by each National Competent Authority. Patients were followed during two years for safety, based on adverse events, and for efficacy, based on clinical assessment (pain and hip score) and imaging (X-rays and MRIs). Patients were also reviewed after 5 to 6 years at latest follow-up for final outcome. Results: No severe adverse event was recalled as related to the ATMP. At 12 months, 16/20 per protocol and 16/22 under intention-to-treat (2 drop-out at 3 and 5 months) maintained head sphericity and showed bone regeneration. Of the 4 hips with ON progression, 3 required total hip replacement (THR). At 5 years, one patient (healed at 2 years visit) was not located, and 16/21 showed no progression or THR, 4/21 had received THR (all in the first year) and 1 had progressed one stage without THR. Conclusions: Expanded MSCs implantation was safe. Early efficacy was confirmed in 80% of cases under protocol at 2 years. At 5 years, the overall results were maintained and 19% converted to THR, all in the first year., publishedVersion

Published
2021

25. MOESM1 of Regulatory T cells from patients with end-stage organ disease can be isolated, expanded and cryopreserved according good manufacturing practice improving their function

Author

Ulbar, Francesca, Montemurro, Tiziana, Jofra, Tatiana, Capri, Miriam, Comai, Giorgia, Bertuzzo, Valentina, Lavazza, Cristiana, Mandelli, Alessandra, Viganò, Mariele, Budelli, Silvia, Bacalini, Maria, Pirazzini, Chiara, Garagnani, Paolo, Giudice, Valeria, Sollazzo, Daria, Curti, Antonio, Arpinati, Mario, Manna, Gaetano La, Cescon, Matteo, Pinna, Antonio, Franceschi, Claudio, Battaglia, Manuela, Giordano, Rosaria, Catani, Lucia, and Lemoli, Roberto

Subjects
chemical and pharmacologic phenomena
Abstract

Additional file 1: Table S1. Antibodies for flow cytometry. Figure S1. Design of the in vivo study. A. Steady state leukapheresis from 2 patients (1 KT and 1 LT patient) were processed using GMP-compliant devices and reagents. Tregs positive fraction (CD8−CD25+ cells) was purified using the CliniMACS System. Forty millions of CD8−CD25 + cells were expanded in vitro for 3 weeks. At day 21 all the cultured cells were collected and the beads were removed using the CliniMACS device, according to manufacturer’s instructions. Negative fraction (CD8−CD25− T cells) after GMP selection at day 0 and the final product after GMP expansion at day 21 were cryopreserved and thawed as described in “Materials and methods” section. B. Irradiated NSG mice were infused with the KT or the LT CD8−CD25− T cells, either alone or in combination with autologous expanded Tregs at 1:1 ratio, to assess their ability to ameliorate GVHD. C. Mice were bled 4/7 weeks after transplantation and sacrificed 7 weeks after transplantation. FACS analysis of the injected cells (day 1), of PB (4 weeks ± 3 days after transplantation) and of PB and spleen (7 weeks ± 3 days after transplantation) was performed. Figure S2. Circulating Tregs in KT and LT patients. Mean absolute number of circulating CD4+CD25+CD127−FoxP3+ Tregs from healthy controls and selected LT and KT patients (p = NS).

Published
2019
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26. Changes in the proteomic profile of adipose tissue-derived mesenchymal stem cells during passages

Author

Capra Emanuele, Beretta Riccardo, Parazzi Valentina, Viganò Mariele, Lazzari Lorenza, Baldi Antonella, and Giordano Rosaria

Subjects
Adipose tissue-derived mesenchymal stem cells, AD-MSC, S-100A6, Calcyclin, SELDI-ToF, Proteomic, Cytology, QH573-671
Abstract

Abstract Background Human mesenchymal stem cells (hMSC) have recently raised the attention because of their therapeutic potential in the novel context of regenerative medicine. However, the safety of these new and promising cellular products should be carefully defined before they can be used in the clinical setting, as. The protein expression profile of these cells might reveal potential hazards associated with senescence and tumoral transformation which may occur during culture. Proteomic is a valuable tool for hMSC characterization and identification of possible changes during expansion. Results We used Surface Enhanced Laser Desorption/Ionization-Time Of Flight-Mass Spectrometry (SELDI-ToF-MS) to evaluate the presence of stable molecular markers in adipose tissue-derived mesenchymal stem cells (AD-MSC) produced under conditions of good manufacturing practices (GMP). Proteomic patterns of cells prepared were consistent, with 4 up-regulated peaks (mass-to-charge ratio (m/z) 8950, 10087, 10345, and 13058) through subculture steps (P0-P7) with similar trend in three donors. Among the differentially expressed proteins found in the cytoplasmic and nuclear fractions, a cytoplasmic 10.1 kDa protein was upregulated during culture passages and was identified as S100A6 (Calcyclin). Conclusions This study suggests for the first time that common variation could occur in AD-MSC from different donors, with the identification of S100A6, a protein prevalently related to cell proliferation and cell culture condition. These results support the hypothesis of common proteomic changes during MSCs expansion and could give important insight in the knowledge of molecular mechanisms intervening during MSC expansion.

Published
2012
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27. Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production

Author

Viganò, Mariele, primary, Budelli, Silvia, additional, Lavazza, Cristiana, additional, Montemurro, Tiziana, additional, Montelatici, Elisa, additional, de Cesare, Stefania, additional, Lazzari, Lorenza, additional, Orlandi, Anna Rosa, additional, Lunghi, Giovanna, additional, and Giordano, Rosaria, additional

Published
2018
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28. Microtubule defects in mesenchymal stromal cells distinguish patients with Progressive Supranuclear Palsy

Author

Calogero, Alessandra Maria, primary, Viganò, Mariele, additional, Budelli, Silvia, additional, Galimberti, Daniela, additional, Fenoglio, Chiara, additional, Cartelli, Daniele, additional, Lazzari, Lorenza, additional, Lehenkari, Petri, additional, Canesi, Margherita, additional, Giordano, Rosaria, additional, Cappelletti, Graziella, additional, and Pezzoli, Gianni, additional

Published
2018
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29. Molecular and functional characterization of CD133 + stem/progenitor cells infused in patients with end-stage liver disease reveals their interplay with stromal liver cells

Author

Catani, Lucia, primary, Sollazzo, Daria, additional, Bianchi, Elisa, additional, Ciciarello, Marilena, additional, Antoniani, Chiara, additional, Foscoli, Licia, additional, Caraceni, Paolo, additional, Giannone, Ferdinando Antonino, additional, Baldassarre, Maurizio, additional, Giordano, Rosaria, additional, Montemurro, Tiziana, additional, Montelatici, Elisa, additional, D'Errico, Antonia, additional, Andreone, Pietro, additional, Giudice, Valeria, additional, Curti, Antonio, additional, Manfredini, Rossella, additional, and Lemoli, Roberto Massimo, additional

Published
2017
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31. Additional file 3: Table S3. of Human cord blood-derived platelet lysate enhances the therapeutic activity of adipose-derived mesenchymal stromal cells isolated from Crohnâ s disease patients in a mouse model of colitis

Author

Forte, Dorian, Ciciarello, Marilena, Valerii, Maria, Fazio, Luigia De, Cavazza, Elena, Giordano, Rosaria, Parazzi, Valentina, Lazzari, Lorenza, Laureti, Silvio, Rizzello, Fernando, Cavo, Michele, Curti, Antonio, Lemoli, Roberto, Spisni, Enzo, and Catani, Lucia

Abstract

Presenting histological damage score criteria. Summary of the criteria used to assign the scores added to determine the histological damage score. (DOC 31 kb)

Published
2015
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32. Additional file 4: Figure S1. of Human cord blood-derived platelet lysate enhances the therapeutic activity of adipose-derived mesenchymal stromal cells isolated from Crohn’s disease patients in a mouse model of colitis

Author

Forte, Dorian, Ciciarello, Marilena, Valerii, Maria, Fazio, Luigia De, Cavazza, Elena, Giordano, Rosaria, Parazzi, Valentina, Lazzari, Lorenza, Laureti, Silvio, Rizzello, Fernando, Cavo, Michele, Curti, Antonio, Lemoli, Roberto, Spisni, Enzo, and Catani, Lucia

Abstract

Showing that Nile Red-labeled adCD-MSCs are viable and maintain phenotypic and differentiative properties as compared with unlabelled cells. Proliferation rate (cell titer assay), immunophenotype (flow cytometry), and differentiation potential (Alizarin red and Oil red O staining) of Nile Red-labeled adCD-MSCs (adCD-MSCs+NR) compared with unlabeled adCD-MSCs. Nile Red-labeled adCD-MSCs are viable and maintain phenotypic and differentiative properties compared with unlabeled cells. a Proliferation rate is evaluated by cell titer assay and expressed as fold-change taking the value of unlabeled cells at each time point as 1. Data expressed as mean ± SEM of at least three experiments. All differences are not significant (p value not significant). NR Nile Red. b Flow cytometric immunophenotype of Nile Red-labeled adCD-MSCs (adCD-MSCs+NR) is similar to that of unlabeled adCD-MSCs. Data expressed as mean ± SEM of at least two experiments. All differences are not significant (p value not significant). As a proof of differentiation potential, osteogenic and adipogenic process are shown. Alizarin red and Oil red O staining of unlabeled c, d and Nile Red-labeled e, f adCD-MSCs cultured for 3 weeks in osteogenic c, e and adipogenic conditions d, f. Magnification 20×; scale bar, 100 μm. (PDF 1843 kb)

Published
2015
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33. Additional file 2: Table S2. of Human cord blood-derived platelet lysate enhances the therapeutic activity of adipose-derived mesenchymal stromal cells isolated from Crohnâ s disease patients in a mouse model of colitis

Author

Forte, Dorian, Ciciarello, Marilena, Valerii, Maria, Fazio, Luigia De, Cavazza, Elena, Giordano, Rosaria, Parazzi, Valentina, Lazzari, Lorenza, Laureti, Silvio, Rizzello, Fernando, Cavo, Michele, Curti, Antonio, Lemoli, Roberto, Spisni, Enzo, and Catani, Lucia

Abstract

Presenting DAI score criteria. Summary of the criteria used to assign the scores added to determine the DAI in mice daily. (DOCX 13 kb)

Published
2015
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34. Additional file 1: Table S1. of Human cord blood-derived platelet lysate enhances the therapeutic activity of adipose-derived mesenchymal stromal cells isolated from Crohnâ s disease patients in a mouse model of colitis

Author

Forte, Dorian, Ciciarello, Marilena, Valerii, Maria, Fazio, Luigia De, Cavazza, Elena, Giordano, Rosaria, Parazzi, Valentina, Lazzari, Lorenza, Laureti, Silvio, Rizzello, Fernando, Cavo, Michele, Curti, Antonio, Lemoli, Roberto, Spisni, Enzo, and Catani, Lucia

Abstract

Presenting sample demographics. Summary of the main features of CD patients from which adCD-MSCs were isolated. Data for healthy donors from which adHD-MSCs were isolated for the comparison of biological properties are also shown. (DOC 34 kb)

Published
2015
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35. Finding a new therapeutic approach for no-option Parkinsonisms: mesenchymal stromal cells for progressive supranuclear palsy

Author

Canesi, Margherita, primary, Giordano, Rosaria, additional, Lazzari, Lorenza, additional, Isalberti, Maurizio, additional, Isaias, Ioannis Ugo, additional, Benti, Riccardo, additional, Rampini, Paolo, additional, Marotta, Giorgio, additional, Colombo, Aurora, additional, Cereda, Emanuele, additional, Dipaola, Mariangela, additional, Montemurro, Tiziana, additional, Viganò, Mariele, additional, Budelli, Silvia, additional, Montelatici, Elisa, additional, Lavazza, Cristiana, additional, Cortelezzi, Agostino, additional, and Pezzoli, Gianni, additional

Published
2016
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37. How we make cell therapy in Italy

Author

Montemurro,Tiziana, Viganò,Mariele, Budelli,Silvia, Montelatici,Elisa, Lavazza,Cristiana, Marino,Luigi, Parazzi,Valentina, Lazzari,Lorenza, Giordano,Rosaria, Montemurro,Tiziana, Viganò,Mariele, Budelli,Silvia, Montelatici,Elisa, Lavazza,Cristiana, Marino,Luigi, Parazzi,Valentina, Lazzari,Lorenza, and Giordano,Rosaria

Abstract

Tiziana Montemurro, Mariele Viganò, Silvia Budelli, Elisa Montelatici, Cristiana Lavazza, Luigi Marino, Valentina Parazzi, Lorenza Lazzari, Rosaria GiordanoCell Factory, Unit of Cell Therapy and Cryobiology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milano, ItalyAbstract: In the 21st century scenario, new therapeutic tools are needed to take up the social and medical challenge posed by the more and more frequent degenerative disorders and by the aging of population. The recent category of advanced therapy medicinal products has been created to comprise cellular, gene therapy, and tissue engineered products, as a new class of drugs. Their manufacture requires the same pharmaceutical framework as for conventional drugs and this means that industrial, large-scale manufacturing process has to be adapted to the peculiar characteristics of cell-containing products. Our hospital took up the challenge of this new path in the early 2000s; and herein we describe the approach we followed to set up a pharmaceutical-grade facility in a public hospital context, with the aim to share the solutions we found to make cell therapy compliant with the requirements for the production and the quality control of a high-standard medicinal product.Keywords: advanced therapy medicinal product, good manufacturing practices, stem cells

Published
2015

38. Human cord blood-derived platelet lysate enhances the therapeutic activity of adipose-derived mesenchymal stromal cells isolated from Crohn’s disease patients in a mouse model of colitis

Author

Forte, Dorian, primary, Ciciarello, Marilena, additional, Valerii, Maria Chiara, additional, De Fazio, Luigia, additional, Cavazza, Elena, additional, Giordano, Rosaria, additional, Parazzi, Valentina, additional, Lazzari, Lorenza, additional, Laureti, Silvio, additional, Rizzello, Fernando, additional, Cavo, Michele, additional, Curti, Antonio, additional, Lemoli, Roberto M., additional, Spisni, Enzo, additional, and Catani, Lucia, additional

Published
2015
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39. How we make cell therapy in Italy

Author

Giordano, Rosaria, primary, Montemurro, Tiziana, additional, Viganò, Mariele, additional, Budelli, Silvia, additional, Montelatici, Elisa, additional, Lavazza, Cristiana, additional, Marino, Luigi, additional, Parazzi, Valentina, additional, and Lazzari, Lorenza, additional

Published
2015
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40. Is it possible to reveal bacterial and fungal contamination in fresh and/or cryopreserved/thawed Advanced Therapy Medicinal Products using a rapid automated system? Results from a GMP validation study

Author

Budelli, Silvia, primary, Perego, Luisa, additional, Viganò, Mariele, additional, Montemurro, Tiziana, additional, Arghittu, Milena, additional, Montelatici, Elisa, additional, Pozzi, Cristina, additional, Lavazza, Cristiana, additional, Marino, Luigi, additional, Parazzi, Valentina, additional, Barilani, Mario, additional, Ragni, Enrico, additional, Lazzari, Lorenza, additional, Torresani, Erminio, additional, and Giordano, Rosaria, additional

Published
2015
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41. Long-living cord blood mesenchymal stem cells and their clinical use

Author

Montemurro, Tiziana, primary, Barilani, Mario, additional, Lavazza, Cristiana, additional, Budelli, Silvia, additional, Viganò, Mariele, additional, Parazzi, Valentina, additional, Marino, Luigi, additional, Montelatici, Elisa, additional, Ragni, Enrico, additional, Giordano, Rosaria, additional, and Lazzari, Lorenza, additional

Published
2015
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42. Autologous mesenchymal stem cell therapy for progressive supranuclear palsy: translation into a phase I controlled, randomized clinical study

Author

Giordano, Rosaria, primary, Canesi, Margherita, additional, Isalberti, Maurizio, additional, Isaias, Ioannis, additional, Montemurro, Tiziana, additional, Viganò, Mariele, additional, Montelatici, Elisa, additional, Boldrin, Valentina, additional, Benti, Riccardo, additional, Cortelezzi, Agostino, additional, Fracchiolla, Nicola, additional, Lazzari, Lorenza, additional, and Pezzoli, Gianni, additional

Published
2014
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43. STEREO PIV ANALYSIS AND APPLICATION TO CYLINDER WAKE

Author

Giordano, Rosaria and Giordano, Rosaria

Abstract

A theoretical analysis of the spatial resolution of the Stereo Particle Image Velocimetry (PIV) technique has been performed. This has been done in terms of Modulation Transfer Function (MTF) and by applying the technique with and without the correction of the misalignment error between calibration and measurement planes. The results show that some wavelengths of the flow field can be significantly dephased and modulated. The theoretical analysis has been extended to investigate also the effects caused by the laser thickness and the linear dimension of the interrogation window W (i.e. the modulation associated to the Stereo PIV process). As it will be shown in detail in this work, the modulation associated to the last two parameters cannot be corrected, differently from the modulation due to the misalignment. A performance assessment has been conducted with both synthetic and real images and shows a good agreement with the theoretical analysis. The reconstruction of the three-dimensional displacement field is achieved using both methods proposed by Soloff et al. (1997) and by Willert (1997). Finally, the Stereo PIV technique has been used to analyse the vortex shedding caused by both finite and infinite cylinders immersed in a uniform flow field. The Reynolds numbers investigated are within the Shear-Layer Transition Regime, indicated by Williamson (1996) for the infinite cylinder. This regime is characterized by the formation of von Kàrmàn vortices. For the finite cylinder, a counter-rotating pair of tip vortices forms at the free end, extends into the wake and interacts in a complex manner with the von Kàrmàn vortex shedding. To detect the von Kàrmàn vortex shedding a phase averaged method has been chosen. This approach uses the Proper Orthogonal Decomposition (POD) technique and it has been evidenced that it works properly for the infinite cylinder and for some sections near the base of the finite one.

Published
2008

44. Effects Of a Novel Ceramic Biomaterial On Immune Modulatory Properties and Differentiation Potential Of Mesenchymal Stromal Cells

Author

Bassi, Giulio, primary, Menard, Cedric, additional, Guilloton, Fabien, additional, Pacelli, Luciano, additional, Carusone, Roberta, additional, Di Trapani, Mariano, additional, Zanoncello, Jasmina, additional, Bifari, Francesco, additional, Sensebé, Luc, additional, Deschaseaux, Fredric, additional, Baroth, Serge, additional, Schrezenmeier, Hubert, additional, Rojewski, Markus, additional, Layrolle, Pierre, additional, Giordano, Rosaria, additional, Lorenza, Lazzari, additional, Lavazza, Cristiana, additional, Bourin, Philippe, additional, Tarte, Karin, additional, and Krampera, Mauro, additional

Published
2013
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45. Off-the-Shelf Cord Blood Mesenchymal Stem Cell Bank

Author

Montemurro,, Tiziana, primary, Lavazza, Cristiana, additional, Andriolo, Gabriella, additional, Viganò, Mariele, additional, Baluce, Barbara, additional, Rebulla, Paolo, additional, Giordano, Rosaria, additional, and Lazzari, Lorenza, additional

Published
2011
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48. CD133+ Pluripotent Stem Cells for the Treatment of Chronic Liver Failure.

Author

Catani, Lucia, primary, Lorenzini, Stefania, additional, Giordano, Rosaria, additional, Caraceni, Paolo, additional, Motta, Maria Rosa, additional, Giudice, Valeria, additional, Montemurro, Tiziana, additional, Giannone, Ferdinando, additional, Sollazzo, Daria, additional, Dan, Elisa, additional, Nicolini, Benedetta, additional, Chelli, Francesca, additional, Baccarani, Michele, additional, Bernardi, Mauro, additional, Losinno, Francesco, additional, Andreone, Pietro, additional, and Lemoli, Roberto M., additional

Published
2010
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49. The Role of PET with 13N-Ammonia and 18F-FDG in the Assessment of Myocardial Perfusion and Metabolism in Patients with Recent AMI and Intracoronary Stem Cell Injection

Author

Castellani, Massimo, primary, Colombo, Alessandro, additional, Giordano, Rosaria, additional, Pusineri, Enrico, additional, Canzi, Cristina, additional, Longari, Virgilio, additional, Piccaluga, Emanuela, additional, Palatresi, Simone, additional, Dellavedova, Luca, additional, Soligo, Davide, additional, Rebulla, Paolo, additional, and Gerundini, Paolo, additional

Published
2010
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