TY - JOUR
T1 - Quality control for clinical islet transplantation
T2 - Organ procurement and preservation, the islet processing facility, isolation, and potency tests
AU - Yamamoto, Toshiyuki
AU - Horiguchi, Akihiko
AU - Ito, Masahiro
AU - Nagata, Hideo
AU - Ichii, Hirohito
AU - Ricordi, Camillo
AU - Miyakawa, Shuichi
PY - 2009/2/26
Y1 - 2009/2/26
N2 - Pancreatic islet transplantation has become one of the ideal treatments for patients with type 1 diabetes mellitus due to improvements in isolation techniques and immunosuppression regimens. In order to ensure the safety and rights of patients, isolated islets need to meet the criteria for regulation as both a biological product and a drug product. For the constant success of transplantation, therefore, all investigators involved in clinical islet transplantation must strive to ensure the safety, purity, and potency of islets in all the phases of clinical islet isolation and transplantation. In this review, we summarize the quality control for clinical islet isolation and transplantation, and the latest topics of pre-transplant islet assessment.
AB - Pancreatic islet transplantation has become one of the ideal treatments for patients with type 1 diabetes mellitus due to improvements in isolation techniques and immunosuppression regimens. In order to ensure the safety and rights of patients, isolated islets need to meet the criteria for regulation as both a biological product and a drug product. For the constant success of transplantation, therefore, all investigators involved in clinical islet transplantation must strive to ensure the safety, purity, and potency of islets in all the phases of clinical islet isolation and transplantation. In this review, we summarize the quality control for clinical islet isolation and transplantation, and the latest topics of pre-transplant islet assessment.
KW - Clinical islet transplantation
KW - Islet potency test
KW - Quality control
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U2 - 10.1007/s00534-009-0064-z
DO - 10.1007/s00534-009-0064-z
M3 - Review article
C2 - 19242650
AN - SCOPUS:63649088074
VL - 16
SP - 131
EP - 136
JO - Journal of Hepato-Biliary-Pancreatic Sciences
JF - Journal of Hepato-Biliary-Pancreatic Sciences
SN - 1868-6974
IS - 2
ER -