Quality control for clinical islet transplantation: organ procurement and preservation, the islet processing facility, isolation, and potency tests.
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.
Yamamoto
Toshiyuki
T
Department of Surgery, School of Medicine, Fujita Health University, Aichi, Japan. yamagen@fujita-hu.ac.jp
Horiguchi
Akihiko
A
Ito
Masahiro
M
Nagata
Hideo
H
Ichii
Hirohito
H
Ricordi
Camillo
C
Miyakawa
Shuichi
S
D001786:Blood Glucose; D003922:Diabetes Mellitus, Type 1 / Q000601:surgery*; D006085:Graft Survival; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods; D016381:Islets of Langerhans Transplantation / Q000379:methods*; D009926:Organ Preservation / Q000379:methods*; D011786:Quality Control; D009927:Tissue and Organ Procurement / Q000379:methods*
D001786:Blood Glucose