The role of current product release criteria for identification of human islet preparations suitable for clinical transplantation

Transplantation Proceedings
M EckhardM D Brendel

Abstract

Alloimmunity, autoimmunity, and nonspecific inflammation are known to be potential determinants for long-term islet survival and insulin independence. Sufficient islet mass is a key determinant. But islet engraftment and posttransplant survival may also depend on functional characteristics of the graft. This study investigated the significance of current product release criteria for the transplantation outcome. Fourty five consecutive transplanted human islet preparations and their functional outcomes were analyzed. Islet mass was determined according to standard criteria: purity by light microscopy, viability by dye exclusion and Insulin secretory response to static glucose incubation. Islet graft function was monitored for > or = 1 year. Islet function was defined as full (FF), partial (PF), or nonfunction (NF) based on serum C-peptide levels and insulin independence. All islet grafts displayed primary function. Islet mass [IEQ/kg BW]: 7331.3 +/- 679.7 (FF), 5821.3 +/- 546.7 (PF), 6468.6 +/- 658.5 (NF), (FF vs PF p = .032) Purity [%] 86.9 +/- 3.1 (FF), 76.0 +/- 2.87 (PF), 88.2 +/- 2.3 (NF) (FF vs PF P =.045, PF vs NF, P = 0.01). (4) Viability [%]:89.2 +/- 2 (FF), 86.2 +/- 1.7 (PF), 87.3 +/- 1.8 (NF) (ns). Stimulation index (S...Continue Reading

References

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Citations

Feb 26, 2010·Transplantation·Matthew S HansonLuis A Fernandez
Nov 12, 2010·Tissue Engineering. Part C, Methods·Amy S JohnsonClark K Colton
Nov 21, 2007·American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons·I R SweetK Ferreri
Jul 28, 2006·American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons·M GotoO Korsgren
Dec 17, 2010·NMR in Biomedicine·Lara LeoniBrian B Roman
Jul 17, 2012·Cell Transplantation·Ikuro OshibeMitusukazu Gotoh
May 15, 2007·Biotechnology and Bioengineering·Klearchos K PapasClark K Colton
Jan 22, 2009·Transplantation·Jae Hyeon KimKyong Soo Park
Jun 27, 2020·Regenerative Medicine·Francis KaranuLisa Stehno-Bittel
Jan 30, 2007·Diabetes Care·Federico Bertuzzi, Camillo Ricordi

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