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 Cure; Tatiana 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

doi:10.3727/096368909X470874

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 journal › Article › peer-review

57 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 HbA_1C levels, and sustained marked decrease in hypoglycemic episodes.

Original language	English (US)
Pages (from-to)	753-767
Number of pages	15
Journal	Cell Transplantation
Volume	18
Issue number	7
DOIs	https://doi.org/10.3727/096368909X470874
State	Published - Jan 1 2009
Externally published	Yes

Keywords

Immunosuppression
Islet transplantation
Registry
Type 1 diabetes

ASJC Scopus subject areas

Transplantation
Biomedical Engineering
Cell Biology

Access to Document

10.3727/096368909X470874

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

Shapiro, AMJ, 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, Cure, P, Froud, T, Hafiz, M, Khan, A, Perez, MI, Rothenberg, L, Silva-Ramos, M, Hering, BJ, Ansite, J, Bland, B, Duderstadt, K, Gibson, C, Hodges, K, Jevne, R, Larson, V, Radosevich, D, Spindler, D, Zylla, D, Fraga, D, Parkey, J, Kramer, C, Nettles, A, Pattou, F, Ezzouaoui, R, Gmyr, V, Kerr-Conte, J, Raverdy, V, Vantyghem, MC, Naji, A, Markmann, EM, McLaughlin, D, Palanjian, M, Deng, S, Goss, JA, Durkop, C, Mote, A, Schock, P, Zgabay, T, Goodpastor, S, Inman, S, Mote, A, Cagliero, E, Dea, A, Omer, AK, Turgeon, H, Weir, G, Kandeel, F, Chen, L, Hacker, J, Iklé, D, Longmate, J, Mullen, Y, Santiago, J, Shiang, KD, Smith, C, Lesiecki, L, Omori, K, LaRose, A, Garfinkel, M, Boone, P, Roberts, M, Skarbek, R, Connors, M, Shah, M, Zhao, P, Lockwood, M, Thomas, S, Murphy, P, Rusk, K, Oberholzer, J, Benedetti, E, Bui, J, Hatipoglu, B, Owens, C, West, D, Avila, J, Hansen, M, Kaplan, B, Martellotto, J, Nash, K, Romagnoli, T, Sadat, K, Salehi, P, Smith, C, Larsen, C, Holbrook, E, Sanders, E, Sears, M, Joseph, J, Hanson, M, Radke, N, Desai, N, Kemp, D, Olack, B, O'Brien, L, Robertson, H, Kaufman, D, Pellar, S, Olszewski, B, Stuart, E, Al-Saden, P, Reinhart, N, Levy, M, Grimes, D, Otken, L, Naziruddin, B, Rossini, A, Hartigan, C, Thompson, M, Wiseman, A, Britz, B, Gill, R, Sours, E, Valentine, A, Wallace, A, Weiner, L, Westbrook, K, Bishop, J, George, S, Stock, P, Posselt, A, Bluestone, J, McElroy, J, Garwood, C, Szot, G, Ramos, D, Rojas, T, Worden, M, Gaber, AO, Bogard, D, Culbreath, B, Fraga, D, Lo, A, McGee-Wilson, D, Greenbaum, C, McCulloch-Olson, M, Reeve, M, Brayman, K, Korsun, A, Langman, L, Carveth, B, Simmons, W, Ketchum, R, Hanschew, M, Marks, W, Baker, T, Levy, G, Cattral, M, Adcock, L, Donat, D, Sheedy, J, Wright, E, Gores, P, Sauzier, G, Williams, D, McGraw, M, Herold, K, Hardy, MA, Comninel, S, Guo, Q, Bader, S, Kelly, J, Liu, Z, Ruiz, EP, Witkowski, P, Barton, FB, Wease, S, Stablein, D, Damodharan, Y, Mandzuk, C, Heitman, A, Cravens, J, Calaway, B, Long, J, Wagner, C & Danoff, R 2009, '2007 Update on allogeneic islet transplantation from the Collaborative Islet Transplant Registry (CITR)', Cell Transplantation, vol. 18, no. 7, pp. 753-767. https://doi.org/10.3727/096368909X470874

@article{61105f1a9f2d4a0ba98cf164af1ab450,

title = "2007 Update on allogeneic islet transplantation from the Collaborative Islet Transplant Registry (CITR)",

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.",

keywords = "Immunosuppression, Islet transplantation, Registry, Type 1 diabetes",

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

year = "2009",

month = jan,

day = "1",

doi = "10.3727/096368909X470874",

language = "English (US)",

volume = "18",

pages = "753--767",

journal = "Cell Transplantation",

issn = "0963-6897",

publisher = "Cognizant Communication Corporation",

number = "7",

}

TY - JOUR

T1 - 2007 Update on allogeneic islet transplantation from the Collaborative Islet Transplant Registry (CITR)

AU - Shapiro, A. M.James

AU - Lakey, Jonathan

AU - Ryan, Edmond

AU - Baker, Shelly

AU - Bourne, Wendy

AU - Dinyari, Parastoo

AU - McCready, Tara

AU - Trasbourg, Chandra

AU - LaBranche, Kathleen

AU - McGee-Wilson, Deborah

AU - Menon, Vijay

AU - Sarmon, Donna

AU - Reswell, Barbara

AU - Wright, Janet

AU - Alejandro, Rodolfo

AU - Ricordi, Camillo

AU - Baidal, David

AU - Blanco-Jivanjee, Yvette

AU - Cereijo, Jacqueline

AU - Cure, Pablo

AU - Froud, Tatiana

AU - Hafiz, Muhammed

AU - Khan, Aisha

AU - Perez, Maria I.

AU - Rothenberg, Lisa

AU - Silva-Ramos, Maricruz

AU - Hering, Bernhard J.

AU - Ansite, Jeff

AU - Bland, Barb

AU - Duderstadt, Kathy

AU - Gibson, Carrie

AU - Hodges, Kathy

AU - Jevne, Robin

AU - Larson, Virgil

AU - Radosevich, David

AU - Spindler, Deborah

AU - Zylla, Dylan

AU - Fraga, Dan

AU - Parkey, Jamen

AU - Kramer, Carol

AU - Nettles, Anne

AU - Pattou, Francois

AU - Ezzouaoui, Rimed

AU - Gmyr, Valery

AU - Kerr-Conte, Julie

AU - Raverdy, Violeta

AU - Vantyghem, Marie Christine

AU - Naji, Ali

AU - Markmann, Eileen M.

AU - McLaughlin, Diane

AU - Palanjian, Maral

AU - Deng, Shaopeng

AU - Goss, John A.

AU - Durkop, Cheryl

AU - Mote, Amy

AU - Schock, Paige

AU - Zgabay, Tiffany

AU - Goodpastor, Sarah

AU - Inman, Shannon

AU - Mote, Amy

AU - Cagliero, Enrico

AU - Dea, Arthur

AU - Omer, A. Kadir

AU - Turgeon, Heather

AU - Weir, Gordon

AU - Kandeel, Fouad

AU - Chen, Leonard

AU - Hacker, Jeanette

AU - Iklé, David

AU - Longmate, Jeffrey

AU - Mullen, Yoko

AU - Santiago, Julia

AU - Shiang, K. D.

AU - Smith, Craig

AU - Lesiecki, Lorraine

AU - Omori, Keiko

AU - LaRose, Arlene

AU - Garfinkel, Marc

AU - Boone, Pam

AU - Roberts, Melissa

AU - Skarbek, Ryan

AU - Connors, Matthew

AU - Shah, Monalee

AU - Zhao, Patrick

AU - Lockwood, Mark

AU - Thomas, Shameka

AU - Murphy, Peggy

AU - Rusk, Kim

AU - Oberholzer, Jose

AU - Benedetti, Enrico

AU - Bui, James

AU - Hatipoglu, Betul

AU - Owens, Charles

AU - West, Derek

AU - Avila, Jose

AU - Hansen, Michael

AU - Kaplan, Bruce

AU - Martellotto, Joan

AU - Nash, Karyn

AU - Romagnoli, Travis

AU - Sadat, Kamel

AU - Salehi, Payam

AU - Smith, Carol

AU - Larsen, Chris

AU - Holbrook, Elizabeth

AU - Sanders, Elsie

AU - Sears, Marti

AU - Joseph, Jenny

AU - Hanson, Matthew

AU - Radke, Nancy

AU - Desai, Niraj

AU - Kemp, Debra

AU - Olack, Barbara

AU - O'Brien, Laura

AU - Robertson, Heather

AU - Kaufman, Dixon

AU - Pellar, Suzanne

AU - Olszewski, Bonnie

AU - Stuart, Elyse

AU - Al-Saden, Patrice

AU - Reinhart, Nina

AU - Levy, Marlon

AU - Grimes, Darrell

AU - Otken, Lori

AU - Naziruddin, Bashoo

AU - Rossini, Aldo

AU - Hartigan, Celia

AU - Thompson, Michael

AU - Wiseman, Alexander

AU - Britz, Betsy

AU - Gill, Ron

AU - Sours, Eather

AU - Valentine, Antony

AU - Wallace, Amy

AU - Weiner, Laurie

AU - Westbrook, Kimber

AU - Bishop, Jennifer

AU - George, Susan

AU - Stock, Peter

AU - Posselt, Andrew

AU - Bluestone, Jeffrey

AU - McElroy, Joan

AU - Garwood, Charlotte

AU - Szot, Greg

AU - Ramos, Debbie

AU - Rojas, Tara

AU - Worden, Michael

AU - Gaber, A. Osama

AU - Bogard, Donna

AU - Culbreath, Barbara

AU - Fraga, Dan

AU - Lo, Agnes

AU - McGee-Wilson, Deborah

AU - Greenbaum, Carla

AU - McCulloch-Olson, Marli

AU - Reeve, Marilyn

AU - Brayman, Kenneth

AU - Korsun, Angie

AU - Langman, Linda

AU - Carveth, Bruce

AU - Simmons, Winsor

AU - Ketchum, Robert

AU - Hanschew, Michael

AU - Marks, William

AU - Baker, Terri

AU - Levy, Gary

AU - Cattral, Mark

AU - Adcock, Lesley

AU - Donat, Dianne

AU - Sheedy, Jill

AU - Wright, Elizabeth

AU - Gores, Paul

AU - Sauzier, Grace

AU - Williams, Deana

AU - McGraw, Melissa

AU - Herold, Kevan

AU - Hardy, Mark A.

AU - Comninel, Susan

AU - Guo, Qiongfen

AU - Bader, Shama

AU - Kelly, Joan

AU - Liu, Zhuoru

AU - Ruiz, Ena Poumian

AU - Witkowski, Piotr

AU - Barton, Franca Benedicty

AU - Wease, Steve

AU - Stablein, Donald

AU - Damodharan, Yamini

AU - Mandzuk, Christina

AU - Heitman, Andrew

AU - Cravens, James

AU - Calaway, Bryan

AU - Long, Jess

AU - Wagner, Chuck

AU - Danoff, Ruth

PY - 2009/1/1

Y1 - 2009/1/1

N2 - 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.

AB - 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.

KW - Immunosuppression

KW - Islet transplantation

KW - Registry

KW - Type 1 diabetes

UR - http://www.scopus.com/inward/record.url?scp=70350651595&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=70350651595&partnerID=8YFLogxK

U2 - 10.3727/096368909X470874

DO - 10.3727/096368909X470874

M3 - Article

C2 - 19796497

AN - SCOPUS:70350651595

SN - 0963-6897

VL - 18

SP - 753

EP - 767

JO - Cell Transplantation

JF - Cell Transplantation

IS - 7

ER -

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

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