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1. 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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2. 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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4. 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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5. 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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6. A comprehensive report of long-term stability data for a range ATMPs: A need to develop guidelines for safe and harmonized stability studies

Author

Capelli, C, Frigerio, S, Lisini, D, Nava, S, Gaipa, G, Belotti, D, Cabiati, B, Budelli, S, Lazzari, L, Bagnarino, J, Tanzi, M, Comoli, P, Perico, N, Introna, M, Golay, J, Capelli, Chiara, Frigerio, Simona, Lisini, Daniela, Nava, Sara, Gaipa, Giuseppe, Belotti, Daniela, Cabiati, Benedetta, Budelli, Silvia, Lazzari, Lorenza, Bagnarino, Jessica, Tanzi, Matteo, Comoli, Patrizia, Perico, Norberto, Introna, Martino, Golay, Josée, Capelli, C, Frigerio, S, Lisini, D, Nava, S, Gaipa, G, Belotti, D, Cabiati, B, Budelli, S, Lazzari, L, Bagnarino, J, Tanzi, M, Comoli, P, Perico, N, Introna, M, Golay, J, Capelli, Chiara, Frigerio, Simona, Lisini, Daniela, Nava, Sara, Gaipa, Giuseppe, Belotti, Daniela, Cabiati, Benedetta, Budelli, Silvia, Lazzari, Lorenza, Bagnarino, Jessica, Tanzi, Matteo, Comoli, Patrizia, Perico, Norberto, Introna, Martino, and Golay, Josée

Abstract

Background aims: Advanced therapy medicinal products (ATMPs) are novel drugs based on genes, cells or tissues developed to treat many different diseases. Stability studies of each new ATMP need to be performed to define its shelf life and guarantee efficacy and safety upon infusion, and these are presently based on guidelines originally drafted for standard pharmaceutical drugs, which have properties and are stored in conditions quite different from cell products. The aim of this report is to provide evidence-based information for stability studies on ATMPs that will facilitate the interlaboratory harmonization of practices in this area. Methods: We have collected and analyzed the results of stability studies on 19 different cell-based experimental ATMPs, produced by five authorized cell factories forming the Lombardy “Plagencell network” for use in 36 approved phase I/II clinical trials; most were cryopreserved and stored in liquid nitrogen vapors for 1 to 13 years. Results: The cell attributes collected in stability studies included cell viability, immunophenotype and potency assays, in particular immunosuppression, cytotoxicity, cytokine release and proliferation/differentiation capacity. Microbiological attributes including sterility, endotoxin levels and mycoplasma contamination were also analyzed. All drug products (DPs), cryopreserved in various excipients containing 10% DMSO and in different primary containers, were very stable long term at <–150°C and did not show any tendency for diminished viability or efficacy for up to 13.5 years. Conclusions: Our data indicate that new guidelines for stability studies, specific for ATMPs and based on risk analyses, should be drafted to harmonize practices, significantly reduce the costs of stability studies without diminishing safety. Some specific suggestions are presented in the discussion.

Published
2022

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

Author

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

Published
2022
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8. A comprehensive report of long-term stability data for a range ATMPs: A need to develop guidelines for safe and harmonized stability studies

Author

Capelli, Chiara, primary, Frigerio, Simona, additional, Lisini, Daniela, additional, Nava, Sara, additional, Gaipa, Giuseppe, additional, Belotti, Daniela, additional, Cabiati, Benedetta, additional, Budelli, Silvia, additional, Lazzari, Lorenza, additional, Bagnarino, Jessica, additional, Tanzi, Matteo, additional, Comoli, Patrizia, additional, Perico, Norberto, additional, Introna, Martino, additional, and Golay, Josée, additional

Published
2022
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9. 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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10. 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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11. 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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12. 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, primary, Budelli, Silvia, additional, Montelatici, Elisa, additional, Viganò, Mariele, additional, Ulbar, Francesca, additional, Catani, Lucia, additional, Cannone, Marta Giulia, additional, Savelli, Sara, additional, Groppelli, Elisa, additional, Lazzari, Lorenza, additional, Lemoli, Roberto M., additional, Cescon, Matteo, additional, Manna, Gaetano La, additional, Giordano, Rosaria, additional, and Montemurro, Tiziana, additional

Published
2021
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13. 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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14. 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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15. 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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16. 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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17. 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

18. 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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19. 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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20. 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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23. How we make cell therapy in Italy.

Author

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

Published
2015
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24. Terutroban, a thromboxane/prostaglandin endoperoxide receptor antagonist, prevents hypertensive vascular hypertrophy and fibrosis.

Author

Gelosa P, Sevin G, Pignieri A, Budelli S, Castiglioni L, Blanc-Guillemaud V, Lerond L, Tremoli E, and Sironi L

Subjects
Animals, Aorta chemistry, Aorta pathology, Atherosclerosis drug therapy, Collagen metabolism, Endothelium, Vascular metabolism, Fibronectins metabolism, Fibrosis, Hyperplasia drug therapy, Hypertrophy pathology, Male, Rats, Rats, Inbred SHR, Sodium Chloride, Dietary metabolism, Transforming Growth Factor beta1 metabolism, Tunica Media metabolism, Tunica Media pathology, Aorta drug effects, Atherosclerosis prevention & control, Endothelium, Vascular drug effects, Hyperplasia prevention & control, Naphthalenes therapeutic use, Propionates therapeutic use, Receptors, Prostaglandin antagonists & inhibitors, Tunica Media drug effects
Abstract

Thromboxane A(2) and other eicosanoids such as isoprostanes contribute to vascular proliferation and atherosclerosis by binding to the thromboxane/prostaglandin endoperoxide receptors. The effects of terutroban, a thromboxane/prostaglandin endoperoxide receptor antagonist, on aorta remodeling were evaluated in spontaneously hypertensive stroke-prone rats (SHRSPs), a model of severe hypertension, endothelial dysfunction, vascular inflammation, and cerebrovascular diseases. Male SHRSPs were allocated to three groups receiving a standard diet (n = 5) or a high-sodium permissive diet plus vehicle (n = 6) or plus terutroban (30 mg · kg(-1) · day(-1); n = 6). After 6 wk of dietary treatment, all of the animals were injected with bromodeoxyuridine and simultaneously euthanized for aorta collection. The aortic media thickness-to-lumen ratio significantly (P < 0.0001) increased in the salt-loaded rats compared with the rats fed a standard diet, whereas terutroban treatment completely prevented media thickening (P < 0.001). When compared with vehicle, terutroban was also effective in preventing cell proliferation in the media, as indicated by the reduced number of bromodeoxyuridine-positive (P < 0.0001) and proliferating cell nuclear antigen-positive cells (P < 0.0001). Severe fibrosis characterized by a significant accumulation of collagen and fibronectin in the vascular wall was observed in the vehicle-treated rats (P < 0.01) but was completely prevented by terutroban (P < 0.001). The latter also inhibited heat shock protein-47 (P < 0.01) and TGF-1β expression (P < 0.001), which were significantly increased by the high-salt diet. In conclusion, terutroban prevents the development of aorta hyperplasia and has beneficial effects on fibrotic processes by affecting TGF-β and heat shock protein-47 expression in SHRSPs. These findings provide mechanistic data supporting the beneficial effects of terutroban in preventing or retarding atherogenesis.

Published
2011
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