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4. Assisting the implementation of screening for type 1 diabetes by using artificial intelligence on publicly available data

Author

Teixeira, Pedro F., Battelino, Tadej, Carlsson, Anneli, Gudbjörnsdottir, Soffia, Hannelius, Ulf, von Herrath, Matthias, Knip, Mikael, Korsgren, Olle, Elding Larsson, Helena, Lindqvist, Anton, Ludvigsson, Johnny, Lundgren, Markus, Nowak, Christoph, Pettersson, Paul, Pociot, Flemming, Sundberg, Frida, Åkesson, Karin, Lernmark, Åke, and Forsander, Gun

Published
2024
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9. Minimum Information about T Regulatory Cells: A Step toward Reproducibility and Standardization

Author

Fuchs, Anke, Gliwiński, Mateusz, Grageda, Nathali, Spiering, Rachel, Abbas, Abul K, Appel, Silke, Bacchetta, Rosa, Battaglia, Manuela, Berglund, David, Blazar, Bruce, Bluestone, Jeffrey A, Bornhäuser, Martin, Brinke, Anja ten, Brusko, Todd M, Cools, Nathalie, Cuturi, Maria Cristina, Geissler, Edward, Giannoukakis, Nick, Gołab, Karolina, Hafler, David A, van Ham, S Marieke, Hester, Joanna, Hippen, Keli, Di Ianni, Mauro, Ilic, Natasa, Isaacs, John, Issa, Fadi, Iwaszkiewicz-Grześ, Dorota, Jaeckel, Elmar, Joosten, Irma, Klatzmann, David, Koenen, Hans, van Kooten, Cees, Korsgren, Olle, Kretschmer, Karsten, Levings, Megan, Marek-Trzonkowska, Natalia Maria, Martinez-Llordella, Marc, Miljkovic, Djordje, Mills, Kingston HG, Miranda, Joana P, Piccirillo, Ciriaco A, Putnam, Amy L, Ritter, Thomas, Roncarolo, Maria Grazia, Sakaguchi, Shimon, Sánchez-Ramón, Silvia, Sawitzki, Birgit, Sofronic-Milosavljevic, Ljiljana, Sykes, Megan, Tang, Qizhi, Vives-Pi, Marta, Waldmann, Herman, Witkowski, Piotr, Wood, Kathryn J, Gregori, Silvia, Hilkens, Catharien MU, Lombardi, Giovanna, Lord, Phillip, Martinez-Caceres, Eva M, and Trzonkowski, Piotr

Subjects
Vaccine Related, Autoimmune Disease, Inflammatory and immune system, minimum information model, T regulatory cells, immunotherapy, good manufacturing practice, cell therapy, immune tolerance, Immunology, Medical Microbiology
Abstract

Cellular therapies with CD4+ T regulatory cells (Tregs) hold promise of efficacious treatment for the variety of autoimmune and allergic diseases as well as posttransplant complications. Nevertheless, current manufacturing of Tregs as a cellular medicinal product varies between different laboratories, which in turn hampers precise comparisons of the results between the studies performed. While the number of clinical trials testing Tregs is already substantial, it seems to be crucial to provide some standardized characteristics of Treg products in order to minimize the problem. We have previously developed reporting guidelines called minimum information about tolerogenic antigen-presenting cells, which allows the comparison between different preparations of tolerance-inducing antigen-presenting cells. Having this experience, here we describe another minimum information about Tregs (MITREG). It is important to note that MITREG does not dictate how investigators should generate or characterize Tregs, but it does require investigators to report their Treg data in a consistent and transparent manner. We hope this will, therefore, be a useful tool facilitating standardized reporting on the manufacturing of Tregs, either for research purposes or for clinical application. This way MITREG might also be an important step toward more standardized and reproducible testing of the Tregs preparations in clinical applications.

Published
2018

12. Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes

Author

Markmann, James F., Rickels, Michael R., Eggerman, Thomas L., Bridges, Nancy D., Lafontant, David E., Qidwai, Julie, Foster, Eric, Clarke, William R., Kamoun, Malek, Alejandro, Rodolfo, Bellin, Melena D., Chaloner, Kathryn, Czarniecki, Christine W., Goldstein, Julia S., Hering, Bernhard J., Hunsicker, Lawrence G., Kaufman, Dixon B., Korsgren, Olle, Larsen, Christian P., Luo, Xunrong, Naji, Ali, Oberholzer, José, Posselt, Andrew M., Ricordi, Camillo, Senior, Peter A., Shapiro, A.M. James, Stock, Peter G., and Turgeon, Nicole A.

Published
2021
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13. Minimum Information about T Regulatory Cells: A Step toward Reproducibility and Standardization.

Author

Fuchs, Anke, Gliwiński, Mateusz, Grageda, Nathali, Spiering, Rachel, Abbas, Abul K, Appel, Silke, Bacchetta, Rosa, Battaglia, Manuela, Berglund, David, Blazar, Bruce, Bluestone, Jeffrey A, Bornhäuser, Martin, Ten Brinke, Anja, Brusko, Todd M, Cools, Nathalie, Cuturi, Maria Cristina, Geissler, Edward, Giannoukakis, Nick, Gołab, Karolina, Hafler, David A, van Ham, S Marieke, Hester, Joanna, Hippen, Keli, Di Ianni, Mauro, Ilic, Natasa, Isaacs, John, Issa, Fadi, Iwaszkiewicz-Grześ, Dorota, Jaeckel, Elmar, Joosten, Irma, Klatzmann, David, Koenen, Hans, van Kooten, Cees, Korsgren, Olle, Kretschmer, Karsten, Levings, Megan, Marek-Trzonkowska, Natalia Maria, Martinez-Llordella, Marc, Miljkovic, Djordje, Mills, Kingston HG, Miranda, Joana P, Piccirillo, Ciriaco A, Putnam, Amy L, Ritter, Thomas, Roncarolo, Maria Grazia, Sakaguchi, Shimon, Sánchez-Ramón, Silvia, Sawitzki, Birgit, Sofronic-Milosavljevic, Ljiljana, Sykes, Megan, Tang, Qizhi, Vives-Pi, Marta, Waldmann, Herman, Witkowski, Piotr, Wood, Kathryn J, Gregori, Silvia, Hilkens, Catharien MU, Lombardi, Giovanna, Lord, Phillip, Martinez-Caceres, Eva M, and Trzonkowski, Piotr

Subjects
T regulatory cells, cell therapy, good manufacturing practice, immune tolerance, immunotherapy, minimum information model, Autoimmune Disease, Vaccine Related, Inflammatory and Immune System, Immunology, Medical Microbiology
Abstract

Cellular therapies with CD4+ T regulatory cells (Tregs) hold promise of efficacious treatment for the variety of autoimmune and allergic diseases as well as posttransplant complications. Nevertheless, current manufacturing of Tregs as a cellular medicinal product varies between different laboratories, which in turn hampers precise comparisons of the results between the studies performed. While the number of clinical trials testing Tregs is already substantial, it seems to be crucial to provide some standardized characteristics of Treg products in order to minimize the problem. We have previously developed reporting guidelines called minimum information about tolerogenic antigen-presenting cells, which allows the comparison between different preparations of tolerance-inducing antigen-presenting cells. Having this experience, here we describe another minimum information about Tregs (MITREG). It is important to note that MITREG does not dictate how investigators should generate or characterize Tregs, but it does require investigators to report their Treg data in a consistent and transparent manner. We hope this will, therefore, be a useful tool facilitating standardized reporting on the manufacturing of Tregs, either for research purposes or for clinical application. This way MITREG might also be an important step toward more standardized and reproducible testing of the Tregs preparations in clinical applications.

Published
2017

15. National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities

Author

Ricordi, Camillo, Goldstein, Julia S, Balamurugan, AN, Szot, Gregory L, Kin, Tatsuya, Liu, Chengyang, Czarniecki, Christine W, Barbaro, Barbara, Bridges, Nancy D, Cano, Jose, Clarke, William R, Eggerman, Thomas L, Hunsicker, Lawrence G, Kaufman, Dixon B, Khan, Aisha, Lafontant, David-Erick, Linetsky, Elina, Luo, Xunrong, Markmann, James F, Naji, Ali, Korsgren, Olle, Oberholzer, Jose, Turgeon, Nicole A, Brandhorst, Daniel, Chen, Xiaojuan, Friberg, Andrew S, Lei, Ji, Wang, Ling-Jia, Wilhelm, Joshua J, Willits, Jamie, Zhang, Xiaomin, Hering, Bernhard J, Posselt, Andrew M, Stock, Peter G, and Shapiro, AM James

Subjects
Biomedical and Clinical Sciences, Clinical Research, Transplantation, Digestive Diseases, Diabetes, Clinical Trials and Supportive Activities, Metabolic and endocrine, Adolescent, Adult, Aged, Female, Humans, Islets of Langerhans, Islets of Langerhans Transplantation, Male, Middle Aged, National Institutes of Health (U.S.), United States, Young Adult, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences
Abstract

Eight manufacturing facilities participating in the National Institutes of Health-sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed.

Published
2016

16. Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia

Author

Hering, Bernhard J, Clarke, William R, Bridges, Nancy D, Eggerman, Thomas L, Alejandro, Rodolfo, Bellin, Melena D, Chaloner, Kathryn, Czarniecki, Christine W, Goldstein, Julia S, Hunsicker, Lawrence G, Kaufman, Dixon B, Korsgren, Olle, Larsen, Christian P, Luo, Xunrong, Markmann, James F, Naji, Ali, Oberholzer, Jose, Posselt, Andrew M, Rickels, Michael R, Ricordi, Camillo, Robien, Mark A, Senior, Peter A, Shapiro, AM James, Stock, Peter G, and Turgeon, Nicole A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Autoimmune Disease, Diabetes, Clinical Trials and Supportive Activities, Prevention, Transplantation, Clinical Research, Metabolic and endocrine, Adult, Blood Glucose, C-Peptide, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Immunosuppression Therapy, Islets of Langerhans Transplantation, Male, Middle Aged, North America, Young Adult, Clinical Islet Transplantation Consortium
Abstract

ObjectiveImpaired awareness of hypoglycemia (IAH) and severe hypoglycemic events (SHEs) cause substantial morbidity and mortality in patients with type 1 diabetes (T1D). Current therapies are effective in preventing SHEs in 50-80% of patients with IAH and SHEs, leaving a substantial number of patients at risk. We evaluated the effectiveness and safety of a standardized human pancreatic islet product in subjects in whom IAH and SHEs persisted despite medical treatment.Research design and methodsThis multicenter, single-arm, phase 3 study of the investigational product purified human pancreatic islets (PHPI) was conducted at eight centers in North America. Forty-eight adults with T1D for >5 years, absent stimulated C-peptide, and documented IAH and SHEs despite expert care were enrolled. Each received immunosuppression and one or more transplants of PHPI, manufactured on-site under good manufacturing practice conditions using a common batch record and standardized lot release criteria and test methods. The primary end point was the achievement of HbA1c 0.0001). No study-related deaths or disabilities occurred. Five of the enrollees (10.4%) experienced bleeds requiring transfusions (corresponding to 5 of 75 procedures), and two enrollees (4.1%) had infections attributed to immunosuppression. Glomerular filtration rate decreased significantly on immunosuppression, and donor-specific antibodies developed in two patients.ConclusionsTransplanted PHPI provided glycemic control, restoration of hypoglycemia awareness, and protection from SHEs in subjects with intractable IAH and SHEs. Safety events occurred related to the infusion procedure and immunosuppression, including bleeding and decreased renal function. Islet transplantation should be considered for patients with T1D and IAH in whom other, less invasive current treatments have been ineffective in preventing SHEs.

Published
2016

25. Contributors

Author

Abrams, Peter, primary, Adler, Joel T., additional, Alejandro, Rodolfo, additional, Alibashe-Ahmed, Mohamed, additional, Alvarez, Ana, additional, Anazawa, Takayuki, additional, Andres, Axel, additional, Antonioli, Barbara, additional, Apete, Alan, additional, Axelrod, David A., additional, Badet, Lionel, additional, Baidal, David, additional, Barrera, Kaylene, additional, Benhamou, Pierre-Yves, additional, Berney, Thierry, additional, Bertoni, Alain Gerald, additional, Bertuzzi, Federico, additional, Boggi, Ugo, additional, Bonner, Caroline, additional, Bozorgzadeh, Adel, additional, Branchereau, Julien, additional, Bromberg, Jonathan, additional, Burke, George W., additional, Buron, Fanny, additional, Caiazzo, Robert, additional, Caldara, Rossana, additional, Camhi, Stephanie S., additional, Cantarovich, Diego, additional, Cardillo, Massimo, additional, Castanares-Zapatero, D., additional, Cattan, Pierre, additional, Chandran, Suresh Rama, additional, Chang, Erin, additional, Chen, Linda, additional, Chetboun, Mikael, additional, Choudhary, Pratik, additional, Ciancio, Gaetano, additional, Cicalese, Maria Pia, additional, Citro, Antonio, additional, Collienne, C., additional, Conte, Caterina, additional, Counter, Claire, additional, Dajani, Khaled Z., additional, Darden, Carly M., additional, De Cobelli, Francesco, additional, de Koning, Eelco J.P., additional, De Leon, Hector, additional, Delalleau, Nathalie, additional, DiChiacchio, Laura, additional, Doppenberg, Jason B., additional, Drachenberg, Cinthia B., additional, Dugnani, Erica, additional, Dunn, Ty B., additional, Engelse, Marten A., additional, Farag, Ahmed, additional, Farney, Alan, additional, Farrow, Anne Elizabeth, additional, Fathi, Ibrahim, additional, Figueiro, Jose, additional, Flatt, Anneliese, additional, Fousteri, Georgia, additional, Fridell, Jonathan A., additional, Friend, Peter J., additional, Gastaldi, Giacomo, additional, Gmyr, Valery, additional, Gonzalez, Javier, additional, Gopal, Jeevan Prakash, additional, Gorus, Frans K., additional, Goto, Masafumi, additional, Gotoh, Mitsukazu, additional, Greget, Michel, additional, Grenet, Dominique, additional, Grossi, Paolo Antonio, additional, Gruessner, Rainer W.G., additional, Gruessner, Angelika C., additional, Harriman, David I., additional, Hawthorne, Wayne J., additional, Hellman, Jarl, additional, Holbert, Brenda Lee, additional, Hubert, Thomas, additional, Iacopi, Sara, additional, Infante, Marco, additional, Jacob, Peter, additional, Johnson, Paul, additional, Kandaswamy, Raja, additional, Karam, Georges, additional, Kaufman, Dixon B., additional, Kendall Jr, W.F., additional, Kensinger, Clark D., additional, Kenyon, Norma S., additional, Kerr-Conte, Julie, additional, Kervella, Delphine, additional, Kessler, Laurence, additional, Kessler, Romain, additional, Keymeulen, Bart, additional, Korsgren, Olle, additional, Lablanche, Sandrine, additional, Lakhani, Muhaib, additional, Lalwani, Neeraj, additional, Laterre, P.F., additional, Lawrence, Michael C., additional, Lee, Frances Tangherlini, additional, Lehmann, Roger, additional, Linetsky, Elina, additional, Ludwig, Barbara, additional, Lundgren, Torbjörn, additional, Luo, Xunrong, additional, Madiraju, SriGita, additional, Maffi, Paola, additional, Magistretti, Paola, additional, Mapihan, Kristell Le, additional, Markmann, James F., additional, Martens, Geert, additional, Martins, Paulo N., additional, Mazzotta, Francesco Antonio, additional, Mekala, Kavya Chitra, additional, Melzi, Raffaella, additional, Mercalli, Alessia, additional, Monti, Paolo, additional, Morsi, Mahmoud, additional, Mosca, Irene, additional, Mourad, M., additional, Muthusamy, Anand S. Rathnasamy, additional, Nano, Rita, additional, Naziruddin, Bashoo, additional, Noel, Christian, additional, O’Callaghan, John, additional, Odorico, Jon S., additional, Olland, Anne, additional, Opara, E.C., additional, Orlando, Giuseppe, additional, Padilla, Nathalia, additional, Papadimitriou, John C., additional, Papalois, Vassilios E., additional, Papas, Klearchos K., additional, Pasquetti, Gianni, additional, Pattou, François, additional, Pellegrini, Silvia, additional, Pernin, Nadine, additional, Perrone, Vittorio Grazio, additional, Piemonti, Lorenzo, additional, Ploeg, Rutger, additional, Powelson, John A., additional, Pugliese, Alberto, additional, Rajan, Shanthini K., additional, Ramanathan, Karthik V., additional, Raverdy, Violeta, additional, Redfield, Robert R., additional, Renz, John, additional, Rickels, Michael R., additional, Rickert, Charles G., additional, Ricordi, Camillo, additional, Rogers, Jeffrey, additional, Scalea, Joseph R., additional, Schold, Jesse D., additional, Scholz, Hanne, additional, Secchi, Antonio, additional, Serrano, Oscar K., additional, Shapiro, A.M. James, additional, Sharma, Sidharth, additional, Sharples, Edward, additional, Shaw, James A.M., additional, Sinha, Sanjay, additional, Socci, Carlo, additional, Squifflet, Jean-Paul G., additional, Stock, Peter G., additional, Stratta, Robert J., additional, Sutherland, David E.R., additional, Tesauro, Manfredi, additional, Thaunat, Olivier, additional, Thévenet, Julien, additional, Troppmann, Christoph, additional, Vantyghem, Marie-Christine, additional, Vendrame, Francesco, additional, Venturini, Massimo, additional, Vianna, Rodrigo, additional, Vistoli, Fabio, additional, von Zur-Mühlen, Bengt, additional, Wittebole, X., additional, Wojtusciszyn, Anne, additional, Zarinsefat, Arya, additional, and Zimmerman, Asha, additional

Published
2020
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36. [18F]MK-7246 for Positron Emission Tomography Imaging of the Beta-Cell Surface Marker GPR44

Author

Cheung, Pierre, Amin, Mohammad A., Zhang, Bo, Lechi, Francesco, Korsgren, Olle, Eriksson, Jonas, Odell, Luke R., Eriksson, Olof, Cheung, Pierre, Amin, Mohammad A., Zhang, Bo, Lechi, Francesco, Korsgren, Olle, Eriksson, Jonas, Odell, Luke R., and Eriksson, Olof

Abstract

The progressive loss of beta-cell mass is a hallmark of diabetes and has been suggested as a complementary approach to studying the progression of diabetes in contrast to the beta-cell function. Non-invasive nuclear medicinal imaging techniques such as Positron Emission Tomography using radiation emitting tracers have thus been suggested as more viable methodologies to visualize and quantify the beta-cell mass with sufficient sensitivity. The transmembrane G protein-coupled receptor GPR44 has been identified as a biomarker for monitoring beta-cell mass. MK-7246 is a GPR44 antagonist that selectively binds to GPR44 with high affinity and good pharmacokinetic properties. Here, we present the synthesis of MK-7246, radiolabeled with the positron emitter fluorine-18 for preclinical evaluation using cell lines, mice, rats and human pancreatic cells. Here, we have described a synthesis and radiolabeling method for producing [18F]MK-7246 and its precursor compound. Preclinical assessments demonstrated the strong affinity and selectivity of [18F]MK-7246 towards GPR44. Additionally, [18F]MK-7246 exhibited excellent metabolic stability, a fast clearance profile from blood and tissues, qualifying it as a promising radioactive probe for GPR44-directed PET imaging., De tre första författarna delar förstaförfattarskapetDe tre sista författarna delar sistaförfattarskapet

Published
2023
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37. PET imaging of neutrophil elastase with 11C-GW457427 in Acute Respiratory Distress Syndrome in pigs

Author

Puuvuori, Emmi, Chiodaroli, Elena, Estrada, Sergio, Cheung, Pierre, Lubenow, Norbert, Sigfridsson, Jonathan, Romelin, Hampus, Ingvast, Sofie, Elgland, Mathias, Liggieri, Francesco, Korsgren, Olle, Perchiazzi, Gaetano, Eriksson, Olof, Antoni, Gunnar, Puuvuori, Emmi, Chiodaroli, Elena, Estrada, Sergio, Cheung, Pierre, Lubenow, Norbert, Sigfridsson, Jonathan, Romelin, Hampus, Ingvast, Sofie, Elgland, Mathias, Liggieri, Francesco, Korsgren, Olle, Perchiazzi, Gaetano, Eriksson, Olof, and Antoni, Gunnar

Abstract

Today, there is a lack of clinically available imaging techniques to detect and quantify specific immune cell populations. Neutrophils are one of the first immune cells at the site of inflammation, and they secrete the serine protease neutrophil elastase (NE), which is crucial in the fight against pathogens. However, the prolonged lifespan of neutrophils increases the risk that patients will develop severe complications, such as acute respiratory distress syndrome (ARDS). Here, we evaluated the novel radiolabeled NE inhibitor 11C-GW457427 in a pig model of ARDS, for detection and quantification of neutrophil activity in the lungs. Methods: ARDS was induced by intravenous administration of oleic acid to 5 farm pigs, and 4 were considered healthy controls. The severity of ARDS was monitored by clinical parameters of lung function and plasma biomarkers. Each pig was studied with 11C-GW457427 and PET/CT, before and after pretreatment with the NE inhibitor GW311616 to determine in vivo binding specificity. PET image data were analyzed as SUVs and correlated with immunohistochemical staining for NE in biopsies. Results: The binding of 11C-GW457427 was increased in pig lungs with induced ARDS (median SUVmean, 1.91; interquartile range [IQR], 1.67-2.55) compared with healthy control pigs (P < 0.05 and P = 0.03, respectively; median SUVmean, 1.04; IQR, 0.66-1.47). The binding was especially strong in lung regions with high levels of NE and ongoing inflammation, as verified by immunohisto-chemistry. The binding was successfully blocked by pretreatment of an NE inhibitor drug, which demonstrated the in vivo specificity of 11C-GW457427 (P < 0.05 and P = 0.04, respectively; median SUVmean, 0.60; IQR, 0.58-0.77). The binding in neutrophil-rich tissues such as bone marrow (P < 0.05 and P = 0.04, respectively; baseline median SUVmean, 5.01; IQR, 4.48-5.49; block median SUVmean, 1.57; IQR, 0.95-1.85) and spleen (median SUVmean, 2.14; IQR, 1.19-2.36) was also high in all pig

Published
2023
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