Quality control for clinical islet transplantation: Organ procurement and preservation, the islet processing facility, isolation, and potency tests

Toshiyuki Yamamoto, Akihiko Horiguchi, Masahiro Ito, Hideo Nagata, Hirohito Ichii, Camillo Ricordi, Shuichi Miyakawa

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)131-136
Number of pages6
JournalJournal of Hepato-Biliary-Pancreatic Surgery
Volume16
Issue number2
DOIs
StatePublished - Feb 26 2009

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Organ Preservation
Islets of Langerhans Transplantation
Tissue and Organ Procurement
Quality Control
Patient Rights
Patient Safety
Biological Products
Type 1 Diabetes Mellitus
Immunosuppression
Transplantation
Research Personnel
Transplants
Safety
Pharmaceutical Preparations

Keywords

  • Clinical islet transplantation
  • Islet potency test
  • Quality control

ASJC Scopus subject areas

  • Surgery
  • Hepatology

Cite this

Quality control for clinical islet transplantation : Organ procurement and preservation, the islet processing facility, isolation, and potency tests. / Yamamoto, Toshiyuki; Horiguchi, Akihiko; Ito, Masahiro; Nagata, Hideo; Ichii, Hirohito; Ricordi, Camillo; Miyakawa, Shuichi.

In: Journal of Hepato-Biliary-Pancreatic Surgery, Vol. 16, No. 2, 26.02.2009, p. 131-136.

Research output: Contribution to journalArticle

Yamamoto, Toshiyuki ; Horiguchi, Akihiko ; Ito, Masahiro ; Nagata, Hideo ; Ichii, Hirohito ; Ricordi, Camillo ; Miyakawa, Shuichi. / Quality control for clinical islet transplantation : Organ procurement and preservation, the islet processing facility, isolation, and potency tests. In: Journal of Hepato-Biliary-Pancreatic Surgery. 2009 ; Vol. 16, No. 2. pp. 131-136.
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