Shipment of human islets for transplantation

H. Ichii, Y. Sakuma, A. Pileggi, Christopher Fraker, A. Alvarez, J. Montelongo, J. Szust, A. Khan, Luca A Inverardi, B. Naziruddin, M. F. Levy, G. B. Klintmalm, J. A. Goss, Rodolfo Alejandro, Camillo Ricordi

Research output: Contribution to journalArticle

72 Citations (Scopus)

Abstract

The use of regional human islet cell processing centers (ICPC) supporting distant clinical islet transplantation programs (CITP) has proven successful in recent clinical trials. Standardization of islet shipping protocols is needed to preserve cell product identity, quantity, quality and sterility, and to meet criteria for transplantation. We evaluated the use of gas-permeable bags for human islet preparation shipment from a single ICPC to two remote CITPs. Product release tests (counts, purity, viability, sterility and potency) were performed at both centers using identical protocols to determine adequacy for transplantation. Thirty-five islet preparations were shipped either immediately after isolation (n = 20) or following culture (n = 15). Islet recovery rate after shipment was higher in cultured preparations, when compared to those not cultured (91.2 ± 4.9% vs. 72.9 ± 4.7%, respectively; p < 0.05), though the overall recovery rate based on isolation and pre-transplant counts was comparable (72.9 ± 4.7% vs. 70.4 ± 3.5%, respectively; p = N.S.). All preparations met product release criteria for transplantation. Additional experiments showed that gas-permeable bags led to improved recovery and potency, when compared to 50-mL conical tubes or to non-gas-permeable bags for shipment. Collectively, our data demonstrate that the use of gas-permeable bags is efficient for clinical-grade and should be preferred also for the shipment of research-grade islet preparations.

Original languageEnglish
Pages (from-to)1010-1020
Number of pages11
JournalAmerican Journal of Transplantation
Volume7
Issue number4
DOIs
StatePublished - Apr 1 2007

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Islets of Langerhans Transplantation
Transplantation
Gases
Islets of Langerhans
Infertility
Clinical Trials
Transplants
Research

Keywords

  • Assessment
  • Gas-permeable bag
  • Islet consortium
  • Islet shipment
  • Islet transplantation

ASJC Scopus subject areas

  • Immunology

Cite this

Shipment of human islets for transplantation. / Ichii, H.; Sakuma, Y.; Pileggi, A.; Fraker, Christopher; Alvarez, A.; Montelongo, J.; Szust, J.; Khan, A.; Inverardi, Luca A; Naziruddin, B.; Levy, M. F.; Klintmalm, G. B.; Goss, J. A.; Alejandro, Rodolfo; Ricordi, Camillo.

In: American Journal of Transplantation, Vol. 7, No. 4, 01.04.2007, p. 1010-1020.

Research output: Contribution to journalArticle

Ichii, H, Sakuma, Y, Pileggi, A, Fraker, C, Alvarez, A, Montelongo, J, Szust, J, Khan, A, Inverardi, LA, Naziruddin, B, Levy, MF, Klintmalm, GB, Goss, JA, Alejandro, R & Ricordi, C 2007, 'Shipment of human islets for transplantation', American Journal of Transplantation, vol. 7, no. 4, pp. 1010-1020. https://doi.org/10.1111/j.1600-6143.2006.01687.x
Ichii H, Sakuma Y, Pileggi A, Fraker C, Alvarez A, Montelongo J et al. Shipment of human islets for transplantation. American Journal of Transplantation. 2007 Apr 1;7(4):1010-1020. https://doi.org/10.1111/j.1600-6143.2006.01687.x
Ichii, H. ; Sakuma, Y. ; Pileggi, A. ; Fraker, Christopher ; Alvarez, A. ; Montelongo, J. ; Szust, J. ; Khan, A. ; Inverardi, Luca A ; Naziruddin, B. ; Levy, M. F. ; Klintmalm, G. B. ; Goss, J. A. ; Alejandro, Rodolfo ; Ricordi, Camillo. / Shipment of human islets for transplantation. In: American Journal of Transplantation. 2007 ; Vol. 7, No. 4. pp. 1010-1020.
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AU - Pileggi, A.

AU - Fraker, Christopher

AU - Alvarez, A.

AU - Montelongo, J.

AU - Szust, J.

AU - Khan, A.

AU - Inverardi, Luca A

AU - Naziruddin, B.

AU - Levy, M. F.

AU - Klintmalm, G. B.

AU - Goss, J. A.

AU - Alejandro, Rodolfo

AU - Ricordi, Camillo

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AB - The use of regional human islet cell processing centers (ICPC) supporting distant clinical islet transplantation programs (CITP) has proven successful in recent clinical trials. Standardization of islet shipping protocols is needed to preserve cell product identity, quantity, quality and sterility, and to meet criteria for transplantation. We evaluated the use of gas-permeable bags for human islet preparation shipment from a single ICPC to two remote CITPs. Product release tests (counts, purity, viability, sterility and potency) were performed at both centers using identical protocols to determine adequacy for transplantation. Thirty-five islet preparations were shipped either immediately after isolation (n = 20) or following culture (n = 15). Islet recovery rate after shipment was higher in cultured preparations, when compared to those not cultured (91.2 ± 4.9% vs. 72.9 ± 4.7%, respectively; p < 0.05), though the overall recovery rate based on isolation and pre-transplant counts was comparable (72.9 ± 4.7% vs. 70.4 ± 3.5%, respectively; p = N.S.). All preparations met product release criteria for transplantation. Additional experiments showed that gas-permeable bags led to improved recovery and potency, when compared to 50-mL conical tubes or to non-gas-permeable bags for shipment. Collectively, our data demonstrate that the use of gas-permeable bags is efficient for clinical-grade and should be preferred also for the shipment of research-grade islet preparations.

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