RESUMEN
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.
Asunto(s)
Separación Celular/métodos , Selección de Donante/métodos , Trasplante de Islotes Pancreáticos/métodos , Islotes Pancreáticos/citología , Recolección de Tejidos y Órganos/métodos , Adolescente , Adulto , Factores de Edad , Anciano , Recuento de Células/normas , Recuento de Células/estadística & datos numéricos , Separación Celular/estadística & datos numéricos , Células Cultivadas/trasplante , Niño , Preescolar , Isquemia Fría/normas , Isquemia Fría/estadística & datos numéricos , Selección de Donante/normas , Selección de Donante/estadística & datos numéricos , Europa (Continente) , Humanos , Lactante , Recién Nacido , Trasplante de Islotes Pancreáticos/normas , Persona de Mediana Edad , Perfusión/métodos , Perfusión/estadística & datos numéricos , Guías de Práctica Clínica como Asunto , Cultivo Primario de Células/métodos , Cultivo Primario de Células/normas , Cultivo Primario de Células/estadística & datos numéricos , Encuestas y Cuestionarios/estadística & datos numéricos , Factores de Tiempo , Recolección de Tejidos y Órganos/normas , Recolección de Tejidos y Órganos/estadística & datos numéricos , Adulto JovenRESUMEN
In December 2018, Diabetes and Diabetologia began requiring authors of papers reporting data obtained from studies on human islets to report critical characteristics of the human islets used for research. The islet community was asked to provide feedback on it. Here is the contribution by the European Consortium for Islet Transplantation.
