Effect of Manufacturing Procedures on Human Islet Isolation from Donor Pancreata Standardized by the North American Islet Donor Score

This study investigates manufacturing procedures that affect islet isolation outcomes from donor pancreata standardized by the North American Islet Donor Score (NAIDS). Islet isolations performed at the University of Illinois, Chicago, from pancreata with NAIDS ≥65 were investigated. The research co...

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Published in:Cell transplantation 2017-01, Vol.26 (1), p.33-44
Main Authors: Yeh, Chun-Chieh, Wang, Ling-Jia, Mcgarrigle, James J., Wang, Yong, Liao, Chien-Chang, Omami, Mustafa, Khan, Arshad, Nourmohammadzadeh, Mohammad, Mendoza-Elias, Joshua, Mccracken, Benjamin, Marchese, Enza, Barbaro, Barbara, Oberholzer, Jose
Format: Article
Language:English
Subjects:
Adult
Aged
Blood Glucose
Cannulation
Collagen (type I)
Collagenase
Enzymes
Female
Humans
Ischemia
Islets of Langerhans - surgery
Islets of Langerhans Transplantation - standards
Logistic Models
Male
Manufacturing
Middle Aged
North America
Pancreas
Perfusion
Tissue Donors - statistics & numerical data
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cited_by cdi_FETCH-LOGICAL-c528t-db337dbcef3d14e6d046ff5f1361230eed40183d244dfa4440658ff829d51dc23
cites cdi_FETCH-LOGICAL-c528t-db337dbcef3d14e6d046ff5f1361230eed40183d244dfa4440658ff829d51dc23
container_end_page 44
container_issue 1
container_start_page 33
container_title Cell transplantation
container_volume 26
creator Yeh, Chun-Chieh
Wang, Ling-Jia
Mcgarrigle, James J.
Wang, Yong
Liao, Chien-Chang
Omami, Mustafa
Khan, Arshad
Nourmohammadzadeh, Mohammad
Mendoza-Elias, Joshua
Mccracken, Benjamin
Marchese, Enza
Barbaro, Barbara
Oberholzer, Jose
description This study investigates manufacturing procedures that affect islet isolation outcomes from donor pancreata standardized by the North American Islet Donor Score (NAIDS). Islet isolations performed at the University of Illinois, Chicago, from pancreata with NAIDS ≥65 were investigated. The research cohort was categorized into two groups based on a postpurification yield either greater than (group A) or less than (group B) 400,000 IEQ. Associations between manufacturing procedures and islet isolation outcomes were analyzed using multivariate logistic or linear regressions. A total of 119 cases were retrieved from 630 islet isolations performed since 2003. Group A is composed of 40 cases with an average postpurified yield of 570,098 IEQ, whereas group B comprised 79 cases with an average yield of 235,987 IEQ. One third of 119 cases were considered successful islet isolations that yielded >400,000 IEQ. The prepurified and postpurified islet product outcome parameters were detailed for future reference. The NAIDS (>80 vs. 65–80) [odds ratio (OR): 2.91, 95% confidence interval (CI): 1.27–6.70], cold ischemic time (≤10 vs. >10 h) (OR: 3.68, 95% CI: 1.61–8.39), and enzyme perfusion method (mechanical vs. manual) (OR: 2.38, 95% CI: 1.01–5.56) were independent determinants for postpurified islet yield ≥400,000 IEQ. The NAIDS (>80, p < 0.001), cold ischemic time (≤10 h, p < 0.05), increased unit of collagenase (p < 0.01), and pancreatic duct cannulation time (
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Islet isolations performed at the University of Illinois, Chicago, from pancreata with NAIDS ≥65 were investigated. The research cohort was categorized into two groups based on a postpurification yield either greater than (group A) or less than (group B) 400,000 IEQ. Associations between manufacturing procedures and islet isolation outcomes were analyzed using multivariate logistic or linear regressions. A total of 119 cases were retrieved from 630 islet isolations performed since 2003. Group A is composed of 40 cases with an average postpurified yield of 570,098 IEQ, whereas group B comprised 79 cases with an average yield of 235,987 IEQ. One third of 119 cases were considered successful islet isolations that yielded >400,000 IEQ. The prepurified and postpurified islet product outcome parameters were detailed for future reference. The NAIDS (>80 vs. 65–80) [odds ratio (OR): 2.91, 95% confidence interval (CI): 1.27–6.70], cold ischemic time (≤10 vs. >10 h) (OR: 3.68, 95% CI: 1.61–8.39), and enzyme perfusion method (mechanical vs. manual) (OR: 2.38, 95% CI: 1.01–5.56) were independent determinants for postpurified islet yield ≥400,000 IEQ. The NAIDS (>80, p < 0.001), cold ischemic time (≤10 h, p < 0.05), increased unit of collagenase (p < 0.01), and pancreatic duct cannulation time (<30 min, p < 0.01) all independently correlated with better islet quantity parameters. Furthermore, cold ischemic time (≤10 h, p < 0.05), liberase MTF (p < 0.001), increased unit of collagenase (p < 0.05), duct cannulation time (<30 min, p < 0.05), and mechanical enzyme perfusion (p < 0.05) were independently associated with better islet morphology score. Analysis of islet manufacturing procedures from the pancreata with standardized quality is essential in identifying technical issues within islet isolation. Adequate processing duration in each step of islet isolation, using liberase MTF, and mechanical enzyme perfusion all affect isolation outcomes.]]></description><identifier>ISSN: 0963-6897</identifier><identifier>EISSN: 1555-3892</identifier><identifier>DOI: 10.3727/096368916X692834</identifier><identifier>PMID: 27524672</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Adult ; Aged ; Blood Glucose ; Cannulation ; Collagen (type I) ; Collagenase ; Enzymes ; Female ; Humans ; Ischemia ; Islets of Langerhans - surgery ; Islets of Langerhans Transplantation - standards ; Logistic Models ; Male ; Manufacturing ; Middle Aged ; North America ; Pancreas ; Perfusion ; Tissue Donors - statistics &amp; numerical data</subject><ispartof>Cell transplantation, 2017-01, Vol.26 (1), p.33-44</ispartof><rights>2017 SAGE Publications Inc</rights><rights>2017 SAGE Publications Inc. 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Adequate processing duration in each step of islet isolation, using liberase MTF, and mechanical enzyme perfusion all affect isolation outcomes.]]></description><subject>Adult</subject><subject>Aged</subject><subject>Blood Glucose</subject><subject>Cannulation</subject><subject>Collagen (type I)</subject><subject>Collagenase</subject><subject>Enzymes</subject><subject>Female</subject><subject>Humans</subject><subject>Ischemia</subject><subject>Islets of Langerhans - surgery</subject><subject>Islets of Langerhans Transplantation - standards</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Manufacturing</subject><subject>Middle Aged</subject><subject>North America</subject><subject>Pancreas</subject><subject>Perfusion</subject><subject>Tissue Donors - statistics &amp; numerical data</subject><issn>0963-6897</issn><issn>1555-3892</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNp1ks1rFDEYxgdRbK3ePUnAi5fRfCdzEUqtdqFqoQreQjZ5szvLTNImGaHe_b-ddetqC14SeJ_n_b35eJrmOcGvmaLqDe4kk7oj8pvsqGb8QXNIhBAt0x192Bxu5XbW1UHzpJQNxlgxKh43B1QJyqWih83P0xDAVZQC-mjjFKyrU-7jCl3k5MBPGQpKEZ1No41oUQao85oGW_u5GnIa0bsUU0YXNroMtlp0WW30Nvv-B3i0vEF1DehTynWNjkfIvdtzdo2XLmV42jwKdijw7HY_ar6-P_1yctaef_6wODk-b52gurZ-yZjySweBecJBesxlCCIQJgllGMBzTDTzlHMfLOccS6FD0LTzgnhH2VGz2HF9shtzlfvR5huTbG9-F1JeGZtr7wYwjtils8E5pztOBLXC40ABHFacSkdm1tsd62pajuAdxJrtcAd6V4n92qzSdyOkUPOnzIBXt4Ccrico1Yx9cTAMNkKaiiFadIowwbbWl_esmzTlOD-VoZzyTivM9ezCO5fLqZQMYX8Ygs02L-Z-XuaWF_9eYt_wJyCzod0Zil3B36n_Bf4C0ADKcw</recordid><startdate>20170101</startdate><enddate>20170101</enddate><creator>Yeh, Chun-Chieh</creator><creator>Wang, Ling-Jia</creator><creator>Mcgarrigle, James J.</creator><creator>Wang, Yong</creator><creator>Liao, Chien-Chang</creator><creator>Omami, Mustafa</creator><creator>Khan, Arshad</creator><creator>Nourmohammadzadeh, Mohammad</creator><creator>Mendoza-Elias, Joshua</creator><creator>Mccracken, Benjamin</creator><creator>Marchese, Enza</creator><creator>Barbaro, Barbara</creator><creator>Oberholzer, Jose</creator><general>SAGE Publications</general><general>Sage Publications Ltd</general><general>SAGE Publishing</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>P64</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20170101</creationdate><title>Effect of Manufacturing Procedures on Human Islet Isolation from Donor Pancreata Standardized by the North American Islet Donor Score</title><author>Yeh, Chun-Chieh ; 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Islet isolations performed at the University of Illinois, Chicago, from pancreata with NAIDS ≥65 were investigated. The research cohort was categorized into two groups based on a postpurification yield either greater than (group A) or less than (group B) 400,000 IEQ. Associations between manufacturing procedures and islet isolation outcomes were analyzed using multivariate logistic or linear regressions. A total of 119 cases were retrieved from 630 islet isolations performed since 2003. Group A is composed of 40 cases with an average postpurified yield of 570,098 IEQ, whereas group B comprised 79 cases with an average yield of 235,987 IEQ. One third of 119 cases were considered successful islet isolations that yielded >400,000 IEQ. The prepurified and postpurified islet product outcome parameters were detailed for future reference. The NAIDS (>80 vs. 65–80) [odds ratio (OR): 2.91, 95% confidence interval (CI): 1.27–6.70], cold ischemic time (≤10 vs. >10 h) (OR: 3.68, 95% CI: 1.61–8.39), and enzyme perfusion method (mechanical vs. manual) (OR: 2.38, 95% CI: 1.01–5.56) were independent determinants for postpurified islet yield ≥400,000 IEQ. The NAIDS (>80, p < 0.001), cold ischemic time (≤10 h, p < 0.05), increased unit of collagenase (p < 0.01), and pancreatic duct cannulation time (<30 min, p < 0.01) all independently correlated with better islet quantity parameters. Furthermore, cold ischemic time (≤10 h, p < 0.05), liberase MTF (p < 0.001), increased unit of collagenase (p < 0.05), duct cannulation time (<30 min, p < 0.05), and mechanical enzyme perfusion (p < 0.05) were independently associated with better islet morphology score. Analysis of islet manufacturing procedures from the pancreata with standardized quality is essential in identifying technical issues within islet isolation. Adequate processing duration in each step of islet isolation, using liberase MTF, and mechanical enzyme perfusion all affect isolation outcomes.]]></abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>27524672</pmid><doi>10.3727/096368916X692834</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record>
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source Sage Journals GOLD Open Access 2024
subjects Adult
Aged
Blood Glucose
Cannulation
Collagen (type I)
Collagenase
Enzymes
Female
Humans
Ischemia
Islets of Langerhans - surgery
Islets of Langerhans Transplantation - standards
Logistic Models
Male
Manufacturing
Middle Aged
North America
Pancreas
Perfusion
Tissue Donors - statistics & numerical data
title Effect of Manufacturing Procedures on Human Islet Isolation from Donor Pancreata Standardized by the North American Islet Donor Score
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