Shipment of human islets for transplantation

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.