2007 Update on allogeneic islet transplantation from the Collaborative Islet Transplant Registry (CITR)

A. M.James Shapiro, Jonathan Lakey, Edmond Ryan, Shelly Baker, Wendy Bourne, Parastoo Dinyari, Tara McCready, Chandra Trasbourg, Kathleen LaBranche, Deborah McGee-Wilson, Vijay Menon, Donna Sarmon, Barbara Reswell, Janet Wright, Rodolfo Alejandro, Camillo Ricordi, David Baidal, Yvette Blanco-Jivanjee, Jacqueline Cereijo, Pablo CureTatiana Froud, Muhammed Hafiz, Aisha Khan, Maria I. Perez, Lisa Rothenberg, Maricruz Silva-Ramos, Bernhard J. Hering, Jeff Ansite, Barb Bland, Kathy Duderstadt, Carrie Gibson, Kathy Hodges, Robin Jevne, Virgil Larson, David Radosevich, Deborah Spindler, Dylan Zylla, Dan Fraga, Jamen Parkey, Carol Kramer, Anne Nettles, Francois Pattou, Rimed Ezzouaoui, Valery Gmyr, Julie Kerr-Conte, Violeta Raverdy, Marie Christine Vantyghem, Ali Naji, Eileen M. Markmann, Diane McLaughlin, Maral Palanjian, Shaopeng Deng, John A. Goss, Cheryl Durkop, Amy Mote, Paige Schock, Tiffany Zgabay, Sarah Goodpastor, Shannon Inman, Amy Mote, Enrico Cagliero, Arthur Dea, A. Kadir Omer, Heather Turgeon, Gordon Weir, Fouad Kandeel, Leonard Chen, Jeanette Hacker, David Iklé, Jeffrey Longmate, Yoko Mullen, Julia Santiago, K. D. Shiang, Craig Smith, Lorraine Lesiecki, Keiko Omori, Arlene LaRose, Marc Garfinkel, Pam Boone, Melissa Roberts, Ryan Skarbek, Matthew Connors, Monalee Shah, Patrick Zhao, Mark Lockwood, Shameka Thomas, Peggy Murphy, Kim Rusk, Jose Oberholzer, Enrico Benedetti, James Bui, Betul Hatipoglu, Charles Owens, Derek West, Jose Avila, Michael Hansen, Bruce Kaplan, Joan Martellotto, Karyn Nash, Travis Romagnoli, Kamel Sadat, Payam Salehi, Carol Smith, Chris Larsen, Elizabeth Holbrook, Elsie Sanders, Marti Sears, Jenny Joseph, Matthew Hanson, Nancy Radke, Niraj Desai, Debra Kemp, Barbara Olack, Laura O'Brien, Heather Robertson, Dixon Kaufman, Suzanne Pellar, Bonnie Olszewski, Elyse Stuart, Patrice Al-Saden, Nina Reinhart, Marlon Levy, Darrell Grimes, Lori Otken, Bashoo Naziruddin, Aldo Rossini, Celia Hartigan, Michael Thompson, Alexander Wiseman, Betsy Britz, Ron Gill, Eather Sours, Antony Valentine, Amy Wallace, Laurie Weiner, Kimber Westbrook, Jennifer Bishop, Susan George, Peter Stock, Andrew Posselt, Jeffrey Bluestone, Joan McElroy, Charlotte Garwood, Greg Szot, Debbie Ramos, Tara Rojas, Michael Worden, A. Osama Gaber, Donna Bogard, Barbara Culbreath, Dan Fraga, Agnes Lo, Deborah McGee-Wilson, Carla Greenbaum, Marli McCulloch-Olson, Marilyn Reeve, Kenneth Brayman, Angie Korsun, Linda Langman, Bruce Carveth, Winsor Simmons, Robert Ketchum, Michael Hanschew, William Marks, Terri Baker, Gary Levy, Mark Cattral, Lesley Adcock, Dianne Donat, Jill Sheedy, Elizabeth Wright, Paul Gores, Grace Sauzier, Deana Williams, Melissa McGraw, Kevan Herold, Mark A. Hardy, Susan Comninel, Qiongfen Guo, Shama Bader, Joan Kelly, Zhuoru Liu, Ena Poumian Ruiz, Piotr Witkowski, Franca Benedicty Barton, Steve Wease, Donald Stablein, Yamini Damodharan, Christina Mandzuk, Andrew Heitman, James Cravens, Bryan Calaway, Jess Long, Chuck Wagner, Ruth Danoff

Research output: Contribution to journalArticle

56 Scopus citations

Abstract

As of October 1, 2007, 25 North American medical institutions and one European islet transplant center reported detailed information to the Registry on 315 allograft recipients, of which 285 were islet alone (IA) and 30 were islet after kidney (IAK). Of the 114 IA recipients expected at 4 years after their last infusion, 12% were insulin independent, 16% were insulin dependent with detectable C-peptide, 40% had no detectable C-peptide, and 32% had missing C-peptide data or were lost to follow-up. Of the IA recipients, 72% achieved insulin independence at least once over 3 years and multiple infusions. Factors associated with achievement of insulin independence included islet size >1.0 expressed as IEQs per islet number [hazard ratio (HR) = 1.5, p = 0.06], additional infusions given (HR = 1.5, p = 0.01), lower pretransplant HbA 1c (HR = 1.2 each %-age unit, p = 0.02), donor given insulin (HR = 2, p = 0.003), daclizumab given at any infusion (HR = 1.9, p = 0.06), and shorter cold storage time (HR = 1.04, p = 0.03), mutually adjusted in a multivariate model. Severe hypoglycemia prevalence was reduced from 78-83% preinfusion to less than 5% throughout the first year post-last infusion, and to 18% adjusted for missing data at 3 years post-last infusion. In Year 1 post-first infusion for IA recipients, 53% experienced a Grade 3-5 or serious adverse event (AE) and 35% experienced a severe AE related to either an infusion procedure or immunosuppression. In Year 1 post-first infusion, 33% of IA subjects and 35% of IAK subjects had an AE related to the infusion procedure, while 35% of IA subjects and only 27% of IAK subjects had an AE related to the immunosuppression therapy. Five deaths were reported, of which two were classified as probably related to the infusion procedure or immunosuppression, and 10 cases of neoplasm, of which two were classified as probably related to the procedure or immunosuppression. Islet transplantation continues to show short-term benefits of insulin independence, normal or near normal HbA1C levels, and sustained marked decrease in hypoglycemic episodes.

Original languageEnglish (US)
Pages (from-to)753-767
Number of pages15
JournalCell Transplantation
Volume18
Issue number7
DOIs
StatePublished - Jan 1 2009
Externally publishedYes

Keywords

  • Immunosuppression
  • Islet transplantation
  • Registry
  • Type 1 diabetes

ASJC Scopus subject areas

  • Biomedical Engineering
  • Cell Biology
  • Transplantation

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  • Cite this

    Shapiro, A. M. J., Lakey, J., Ryan, E., Baker, S., Bourne, W., Dinyari, P., McCready, T., Trasbourg, C., LaBranche, K., McGee-Wilson, D., Menon, V., Sarmon, D., Reswell, B., Wright, J., Alejandro, R., Ricordi, C., Baidal, D., Blanco-Jivanjee, Y., Cereijo, J., ... Danoff, R. (2009). 2007 Update on allogeneic islet transplantation from the Collaborative Islet Transplant Registry (CITR). Cell Transplantation, 18(7), 753-767. https://doi.org/10.3727/096368909X470874