BACKGROUND: Europe is currently the most active region in the field of pancreatic islet transplantation, and many of the leading groups are actually achieving similar good outcomes. Further collaborative advances in the field require the standardization of islet cell product isolation processes, and this work aimed to identify differences in the human pancreatic islet isolation processes within European countries. METHODS: A web-based questionnaire about critical steps, including donor selection, pancreas processing, pancreas perfusion and digestion, islet counting and culture, islet quality evaluation, microbiological evaluation, and release criteria of the product, was completed by isolation facilities participating at the Ninth International European Pancreas and Islet Transplant Association (EPITA) Workshop on Islet-Beta Cell Replacement in Milan. RESULTS: Eleven islet isolation facilities completed the questionnaire. The facilities reported 445 and 53 islet isolations per year over the last 3 years from deceased organ donors and pancreatectomized patients, respectively. This activity resulted in 120 and 40 infusions per year in allograft and autograft recipients, respectively. Differences among facilities emerged in donor selection (age, cold ischemia time, intensive care unit length, amylase concentration), pancreas procurement, isolation procedures (brand and concentration of collagenase, additive, maximum acceptable digestion time), quality evaluation, and release criteria for transplantation (glucose-stimulated insulin secretion tests, islet numbers, and purity). Moreover, even when a high concordance about the relevance of one parameter was evident, thresholds for the acceptance were different among facilities. CONCLUSIONS: The result highlighted the presence of a heterogeneity in the islet cell product process and product release criteria.

• MeSH
• Time Factors MeSH
• Child MeSH
• Adult MeSH
• Infant MeSH
• Cells, Cultured transplantation   MeSH
• Islets of Langerhans cytology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Infant, Newborn MeSH
• Tissue and Organ Harvesting methods   standards   statistics & numerical data   MeSH
• Perfusion methods   statistics & numerical data   MeSH
• Cell Count standards   statistics & numerical data   MeSH
• Child, Preschool MeSH
• Primary Cell Culture methods   standards   statistics & numerical data   MeSH
• Surveys and Questionnaires statistics & numerical data   MeSH
• Aged MeSH
• Cell Separation methods   statistics & numerical data   MeSH
• Practice Guidelines as Topic MeSH
• Cold Ischemia standards   statistics & numerical data   MeSH
• Islets of Langerhans Transplantation methods   standards   MeSH
• Age Factors MeSH
• Donor Selection methods   standards   statistics & numerical data   MeSH
• Check Tag
• Child MeSH
• Adult MeSH
• Infant MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Infant, Newborn MeSH
• Child, Preschool MeSH
• Aged MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Europe MeSH