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Heterogeneity of human pancreatic islet isolation around Europe

results of a survey study.

Nano, Rita MSc1,*; Kerr-Conte, Julie A. PhD2,*; Scholz, Hanne PhD3,*; Engelse, Marten PhD4; Karlsson, Marie PhD5; Saudek, Frantisek MD6; Bosco, Domenico PhD7; Antonioli, Barbara MSc8; Bertuzzi, Federico MD8; Johnson, Paul R.V. MD9; Ludwing, Barbara MD10; Ling, Zhidong PhD11; De Paep, Diedert L. MD11; Keymeulen, Bart MD, PhD11; Pattou, François MD2; Berney, Thierry MD, MSc7; Korsgren, Olle MD, PhD5; de Koning, Eelco MD, PhD4; Piemonti, Lorenzo MD1,12

doi: 10.1097/TP.0000000000002777
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Aim. 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 9th 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/year over last 3 years from deceased organ donors and pancreatectomized patients, respectively. This activity resulted in 120 and 40 infusions/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 /interpretation. The result highlighted the presence of a heterogeneity in the islet cell product process and product release criteria.

1 Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy

2 European Genomic Institute for Diabetes, University Hospital Lille, Lille, France

3 Department of Transplant Medicine, Oslo University Hospital, Oslo, Norway.

4 Leiden University Medical Center, Department of Nephrology, Leiden, Netherlands.

5 Uppsala University Hospital, Uppsala, Sweden

6 Diabetes Center, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.

7 Hôpitaux Universitaires de Genève,Genève, Switzerland

8 Diabetology Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

9 Islet Transplant Research Group, Nuffield Department of Surgical Sciences and Oxford Centre for Diabetes, University of Oxford, Oxford, United Kingdom.

10 Department of Medicine III, University Hospital Carl Gustav Carus Dresden, Dresden, Germany.

11 Academic Hospital and Diabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium.

12 Vita-Salute San Raffaele University, Milan, Italy.

* Authors equally contributed

CONTRIBUTION STATEMENT: RN, JAK-C, HS, ME, MK, DB, BA, FB, BL, BK, FS, ZL, DLDP, PRVJ performed islet isolation, provided data and contributed to the discussion. RN, JAK-C, HS and LP developed the concept, analysed the data and wrote the manuscript. FP, TB, OK, EdK and LP promoted the study and researched data. All authors approved the version submitted for publication. LP is the guarantor of this work.

DUALITY OF INTEREST: The authors declare that there is no duality of interest associated with this manuscript.

FUNDING: The Juvenile Diabetes Research Foundation International supported this research (ECIT Islets for Research)

DATA AVAILABILITY: The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.

Correspondence to: Lorenzo Piemonti, Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132 Milan. Fax: 39 02 26432871. Tel: 39 02 26432706. E-mail: piemonti.lorenzo@hsr.it

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