Heterogeneity of Human Pancreatic Islet Isolation Around Europe: Results of a Survey Study.
Adolescent
Adult
Age Factors
Aged
Cell Count
/ standards
Cell Separation
/ methods
Cells, Cultured
/ transplantation
Child
Child, Preschool
Cold Ischemia
/ standards
Donor Selection
/ methods
Europe
Humans
Infant
Infant, Newborn
Islets of Langerhans
/ cytology
Islets of Langerhans Transplantation
/ methods
Middle Aged
Perfusion
/ methods
Practice Guidelines as Topic
Primary Cell Culture
/ methods
Surveys and Questionnaires
/ statistics & numerical data
Time Factors
Tissue and Organ Harvesting
/ methods
Young Adult
Journal
Transplantation
ISSN: 1534-6080
Titre abrégé: Transplantation
Pays: United States
ID NLM: 0132144
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
pubmed:
1
8
2019
medline:
2
10
2020
entrez:
1
8
2019
Statut:
ppublish
Résumé
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. 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. 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. The result highlighted the presence of a heterogeneity in the islet cell product process and product release criteria.
Sections du résumé
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.
Identifiants
pubmed: 31365472
doi: 10.1097/TP.0000000000002777
pii: 00007890-202001000-00036
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
190-196Références
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