Shipment of Human Islets for Transplantation

• Published in: American journal of transplantation Vol. 7; no. 4; pp. 1010 - 1020
• Main Authors: Ichii, H., Sakuma, Y., Pileggi, A., Fraker, C., Alvarez, A., Montelongo, J., Szust, J., Khan, A., Inverardi, L., Naziruddin, B., Levy, M. F., Klintmalm, G. B., Goss, J. A., Alejandro, R., Ricordi, C.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.04.2007; Blackwell
• Subjects: Assessment; Biological and medical sciences; Cell Culture Techniques - methods; Cell Survival; Diabetes. Impaired glucose tolerance; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; gas‐permeable bag; Humans; islet consortium; islet shipment; islet transplantation; Islets of Langerhans - cytology; Medical sciences; Organ Transplantation; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Time Factors; Tissue and Organ Harvesting - methods; Tissue and Organ Procurement - methods; Tissue and Organ Procurement - organization & administration; Endocrinopathy; Human; Diabetes mellitus; Langerhans islet; Assessment; islet shipment; Homograft; Bag; gas-permeable bag; islet consortium; Graft; islet transplantation; Endocrine pancreas
• ISSN: 1600-6135; 1600-6143
• DOI: 10.1111/j.1600-6143.2006.01687.x

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. For regional human islet cell processing centers to support distant clinical islet transplantation programs, standardization of islet shipping protocols is needed. This study demonstrates the utility of gas‐permeable bags.