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2. Targeting CXCR1/2 Does Not Improve Insulin Secretion After Pancreatic Islet Transplantation: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial in Type 1 Diabetes

Author

Maffi P., Lundgren T., Tufveson G., Rafael E., Shaw J. A. M., Liew A., Saudek F., Witkowski P., Golab K., Bertuzzi F., Gustafsson B., Daffonchio L., Ruffini P. A., Piemonti L., Nano R., Mercalli A., Lampasona V., Magistretti P., Sordi V., Antonio S., Antonioli B., Galuzzi M., Tosca M. C., De Carlis L., Colussi G., Korsgren O., Pollard H., Maffi, Paola, Lundgren, Torbjörn, Tufveson, Gunnar, Rafael, Ehab, Shaw, James A M, Liew, Aaron, Saudek, Frantisek, Witkowski, Piotr, Golab, Karolina, Bertuzzi, Federico, Gustafsson, Bengt, Daffonchio, Luisa, Ruffini, Pier Adelchi, Piemonti, Lorenzo, Maffi, P, Lundgren, T, Tufveson, G, Rafael, E, Shaw, J, Liew, A, Saudek, F, Witkowski, P, Golab, K, Bertuzzi, F, Gustafsson, B, Daffonchio, L, Ruffini, P, Piemonti, L, Nano, R, Mercalli, A, Lampasona, V, Magistretti, P, Sordi, V, Antonio, S, Antonioli, B, Galuzzi, M, Tosca, M, De Carlis, L, Colussi, G, Korsgren, O, and Pollard, H

Subjects
Male, Time Factors, Endocrinology, Diabetes and Metabolism, Islets of Langerhans Transplantation, Placebo-controlled study, Gastroenterology, Receptors, Interleukin-8B, Receptors, Interleukin-8A, law.invention, Placebos, 0302 clinical medicine, Randomized controlled trial, law, Insulin Secretion, Postoperative Period, 030212 general & internal medicine, Sulfonamides, geography.geographical_feature_category, Clinical Care/Education/Nutrition/Psychosocial Research, Area under the curve, Middle Aged, Islet, Combined Modality Therapy, Female, Immunosuppressive Agents, Adult, medicine.medical_specialty, Adolescent, 030209 endocrinology & metabolism, Placebo, Drug Administration Schedule, Young Adult, Islets of Langerhans, 03 medical and health sciences, Double-Blind Method, Internal medicine, CXCR1/2, insulin secretion, pancreatic islet transplantation, Internal Medicine, medicine, Humans, Aged, Advanced and Specialized Nursing, geography, Type 1 diabetes, business.industry, medicine.disease, Transplantation, Diabetes Mellitus, Type 1, Pancreatic islet transplantation, business
Abstract

OBJECTIVE Reparixin is an inhibitor of CXCR1/2 chemokine receptor shown to be an effective anti-inflammatory adjuvant in a pilot clinical trial in allotransplant recipients. RESEARCH DESIGN AND METHODS A phase 3, multicenter, randomized, double-blind, parallel-assignment study (NCT01817959) was conducted in recipients of islet allotransplants randomized (2:1) to reparixin or placebo in addition to immunosuppression. Primary outcome was the area under the curve (AUC) for C-peptide during the mixed-meal tolerance test at day 75 ± 5 after the first and day 365 ± 14 after the last transplant. Secondary end points included insulin independence and standard measures of glycemic control. RESULTS The intention-to-treat analysis did not show a significant difference in C-peptide AUC at both day 75 (27 on reparixin vs. 18 on placebo, P = 0.99) and day 365 (24 on reparixin vs. 15 on placebo, P = 0.71). There was no statistically significant difference between treatment groups at any time point for any secondary variable. Analysis of patient subsets showed a trend for a higher percentage of subjects retaining insulin independence for 1 year after a single islet infusion in patients receiving reparixin as compared with patients receiving placebo (26.7% vs. 0%, P = 0.09) when antithymocyte globulin was used as induction immunosuppression. CONCLUSIONS In this first double-blind randomized trial, islet transplantation data obtained with reparixin do not support a role of CXCR1/2 inhibition in preventing islet inflammation-mediated damage.

Published
2020

3. Targeting CXCR1/2 does not improve insulin secretion after pancreatic islet transplantation: A phase 3, double-blind, randomized, placebo-controlled trial in type 1 diabetes

Author

Maffi, P, Lundgren, T, Tufveson, G, Rafael, E, Shaw, J, Liew, A, Saudek, F, Witkowski, P, Golab, K, Bertuzzi, F, Gustafsson, B, Daffonchio, L, Ruffini, P, Piemonti, L, Nano, R, Mercalli, A, Lampasona, V, Magistretti, P, Sordi, V, Antonio, S, Antonioli, B, Galuzzi, M, Tosca, M, De Carlis, L, Colussi, G, Korsgren, O, Pollard, H, Maffi P., Lundgren T., Tufveson G., Rafael E., Shaw J. A. M., Liew A., Saudek F., Witkowski P., Golab K., Bertuzzi F., Gustafsson B., Daffonchio L., Ruffini P. A., Piemonti L., Nano R., Mercalli A., Lampasona V., Magistretti P., Sordi V., Antonio S., Antonioli B., Galuzzi M., Tosca M. C., De Carlis L., Colussi G., Korsgren O., Pollard H., Maffi, P, Lundgren, T, Tufveson, G, Rafael, E, Shaw, J, Liew, A, Saudek, F, Witkowski, P, Golab, K, Bertuzzi, F, Gustafsson, B, Daffonchio, L, Ruffini, P, Piemonti, L, Nano, R, Mercalli, A, Lampasona, V, Magistretti, P, Sordi, V, Antonio, S, Antonioli, B, Galuzzi, M, Tosca, M, De Carlis, L, Colussi, G, Korsgren, O, Pollard, H, Maffi P., Lundgren T., Tufveson G., Rafael E., Shaw J. A. M., Liew A., Saudek F., Witkowski P., Golab K., Bertuzzi F., Gustafsson B., Daffonchio L., Ruffini P. A., Piemonti L., Nano R., Mercalli A., Lampasona V., Magistretti P., Sordi V., Antonio S., Antonioli B., Galuzzi M., Tosca M. C., De Carlis L., Colussi G., Korsgren O., and Pollard H.

Abstract

OBJECTIVE Reparixin is an inhibitor of CXCR1/2 chemokine receptor shown to be an effective anti-inflammatory adjuvant in a pilot clinical trial in allotransplant recipients. RESEARCH DESIGN AND METHODS A phase 3, multicenter, randomized, double-blind, parallel-assignment study (NCT01817959) was conducted in recipients of islet allotransplants randomized (2:1) to reparixin or placebo in addition to immunosuppression. Primary outcome was the area under the curve (AUC) for C-peptide during the mixed-meal tolerance test at day 75 6 5 after the first and day 365 6 14 after the last transplant. Secondary end points included insulin independence and standard measures of glycemic control. RESULTS The intention-to-treat analysis did not show a significant difference in C-peptide AUC at both day 75 (27 on reparixin vs. 18 on placebo, P 5 0.99) and day 365 (24 on reparixin vs. 15 on placebo, P 5 0.71). There was no statistically significant difference between treatment groups at any time point for any secondary variable. Analysis of patient subsets showed a trend for a higher percentage of subjects retaining insulin independence for 1 year after a single islet infusion in patients receiving reparixin as compared with patients receiving placebo (26.7% vs. 0%, P 5 0.09) when antithymocyte globulin was used as induction immunosuppression. CONCLUSIONS In this first double-blind randomized trial, islet transplantation data obtained with reparixin do not support a role of CXCR1/2 inhibition in preventing islet inflammation-mediated damage.

Published
2020

4. PET-CT imaging of CD69 in rheumatoid arthritis model

Author

Puuvuori, E., Shen, Y., Zhang, B., Billstrom, G. Hulsart, Persson, Jonas, Ståhl, Stefan, Korsgren, O., Lofblom, J., Wermeling, F., Eriksson, O., Puuvuori, E., Shen, Y., Zhang, B., Billstrom, G. Hulsart, Persson, Jonas, Ståhl, Stefan, Korsgren, O., Lofblom, J., Wermeling, F., and Eriksson, O.

Abstract

QC 20221101

Published
2022

18. The diagnosis of insulitis in human type 1 diabetes

Author

Campbell-Thompson, M. L., Atkinson, M. A., Butler, A. E., Chapman, N. M., Frisk, G., Gianani, R., Giepmans, B. N., von Herrath, M. G., Hyöty, H., Kay, T. W., Korsgren, O., Morgan, N. G., Powers, A. C., Pugliese, A., Richardson, S. J., Rowe, P. A., Tracy, S., and In’t Veld, P. A.

Published
2013
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46. Minimum Information about T Regulatory Cells: A Step toward Reproducibility and Standardization

Author

Fuchs, A., Gliwinski, M., Grageda, N., Spiering, R., Abbas, A.K., Appel, S., Bacchetta, R., Battaglia, M., Berglund, D., Blazar, B., Bluestone, J.A., Bornhauser, M., Brinke, A. Ten, Brusko, T.M., Cools, N., Cuturi, M.C., Geissler, E., Giannoukakis, N., Golab, K., Hafler, D.A., Ham, S.M. van, Hester, J., Hippen, K., Ianni, M. Di, Ilic, N., Isaacs, J., Issa, F., Iwaszkiewicz-Grzes, D., Jaeckel, E., Joosten, I., Klatzmann, D., Koenen, H., Kooten, C. van, Korsgren, O., Kretschmer, K., Levings, M., Marek-Trzonkowska, N.M., Martinez-Llordella, M., Miljkovic, D., Mills, K.H., Miranda, J.P., Piccirillo, C.A., Putnam, A.L., Ritter, T., Roncarolo, M.G., Sakaguchi, S., Sanchez-Ramon, S., Sawitzki, B., Sofronic-Milosavljevic, L., Sykes, M., Tang, Q., Vives-Pi, M., Waldmann, H., Witkowski, P., Wood, K.J., Gregori, S., Hilkens, C.M., Lombardi, G., Lord, P., Martinez-Caceres, E.M., Trzonkowski, P., Fuchs, A., Gliwinski, M., Grageda, N., Spiering, R., Abbas, A.K., Appel, S., Bacchetta, R., Battaglia, M., Berglund, D., Blazar, B., Bluestone, J.A., Bornhauser, M., Brinke, A. Ten, Brusko, T.M., Cools, N., Cuturi, M.C., Geissler, E., Giannoukakis, N., Golab, K., Hafler, D.A., Ham, S.M. van, Hester, J., Hippen, K., Ianni, M. Di, Ilic, N., Isaacs, J., Issa, F., Iwaszkiewicz-Grzes, D., Jaeckel, E., Joosten, I., Klatzmann, D., Koenen, H., Kooten, C. van, Korsgren, O., Kretschmer, K., Levings, M., Marek-Trzonkowska, N.M., Martinez-Llordella, M., Miljkovic, D., Mills, K.H., Miranda, J.P., Piccirillo, C.A., Putnam, A.L., Ritter, T., Roncarolo, M.G., Sakaguchi, S., Sanchez-Ramon, S., Sawitzki, B., Sofronic-Milosavljevic, L., Sykes, M., Tang, Q., Vives-Pi, M., Waldmann, H., Witkowski, P., Wood, K.J., Gregori, S., Hilkens, C.M., Lombardi, G., Lord, P., Martinez-Caceres, E.M., and Trzonkowski, P.

Abstract

Contains fulltext : 191000.pdf (publisher's version ) (Open Access), 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

48. Expression of complement regulatory proteins on islets of Langerhans: a comparison between human islets and islets isolated from normal and hDAF transgenic pigs

Author

Bennet, W, Björkland, A, Sundberg, B, Brandhorst, D, Brendel, MD, Richards, A, White, DJ, Nilsson, B, Groth, CG, and Korsgren, O

Subjects
endocrine system, endocrine system diseases
Abstract

BACKGROUND: The expression of regulators of complement activity (RCAs) on islet cells may be of great importance for protecting them against complement-mediated lysis in the immediate posttransplant period after intraportal islet transplantation. We examined porcine and human islet cells for expression of RCA. We also examined to what extent human decay accelerating factor (hDAF) is expressed on adult and fetal islet cells isolated from hDAF transgenic (TG) pigs having a high transgene expression on endothelial cells. Moreover, the susceptibility of the various types of cells to lysis in human serum and blood was investigated. METHODS: Adult human islets (n=5), normal adult and fetal porcine islets (n=9 and n=8, respectively), and islets from adult and fetal hDAF TG pigs (n=5 and n=6, respectively) were examined. With islet single-cell suspensions and flow cytometry, adult human islet cells were examined for expression of hDAF (CD55), hCD59, and human membrane cofactor protein (hMCP; CD46), while porcine islet cells were examined for expression of pCD59 and pMCP. Islet cells from hDAF TG pigs were also examined for hDAF expression. Porcine peripheral blood lymphocytes, normal and hDAF TG porcine endothelial cell lines, a human endothelial cell line, and the human cell line U937 served as controls. Islet cytotoxicity was assayed after incubation of the islet cells with fresh human serum. Furthermore, adult islets from normal control pigs and hDAF TG pigs were exposed to fresh human blood in vitro for 60 min, and the inflammatory reaction elicited was compared between the different types of islets. RESULTS: All human islet cell preparations expressed hCD59, two of five expressed hMCP, but none expressed hDAF. Porcine islet cells expressed both pCD59 and pMCP. Normal adult porcine islet cells exposed to fresh human serum resulted in 74+/-5.4% cell lysis (mean+/-SEM, n=16). In comparison, only 1.3+/-2.8% (n=20, P

Published
2016

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