作者: H. Ichii , Y. Sakuma , A. Pileggi , C. Fraker , A. Alvarez
DOI: 10.1111/J.1600-6143.2006.01687.X
关键词: Recovery rate 、 Internal medicine 、 Transplantation 、 Medicine 、 Cell processing 、 Potency 、 Islet 、 Endocrinology 、 Andrology 、 Sterility
摘要: The use of regional human islet cell processing centers (ICPC) supporting distant clinical transplantation programs (CITP) has proven successful in recent trials. Standardization shipping protocols is needed to preserve product identity, quantity, quality and sterility, meet criteria for transplantation.We evaluated the gas-permeable bags preparation shipment from a single ICPC two remote CITPs. Product release tests (counts, purity, viability, sterility potency) were performed at both using identical determine adequacy transplantation.Thirty-five preparations shipped either immediately after isolation (n = 20) or following culture 15). Islet recovery rate was higher cultured preparations, when compared those not (91.2 ± 4.9% vs. 72.9 4.7%, respectively; p < 0.05), though overall based on pre-transplant counts comparable (72.9 4.7% 70.4 3.5%, N.S.). All met transplantation. Additional experiments showed that led improved potency, 50-mL conical tubes non-gas-permeable shipment.Collectively, our data demonstrate efficient clinical-grade should be preferred also research-grade preparations.