Effect of manufacturing procedures on human islet isolation from donor pancreata standardized by the North American islet donor score

Chun Chieh Yeh, Ling Jia Wang, James J. McGarrigle, Yong Wang, Chien Chang Liao, Mustafa Omami, Arshad Khan, Mohammad Nourmohammadzadeh, Joshua Mendoza-Elias, Benjamin McCracken, Enza Marchese, Barbara Barbaro, Jose Oberholzer

Research output: Contribution to journalArticle

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Abstract

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 ³65 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 ³400,000 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.

Original languageEnglish
Pages (from-to)33-44
Number of pages12
JournalCell Transplantation
Volume26
Issue number1
DOIs
Publication statusPublished - 2017

Fingerprint

Cold Ischemia
Pancreas
Enzymes
Ducts
Perfusion
Odds Ratio
Collagenases
Confidence Intervals
Catheterization
Linear regression
Logistics
Pancreatic Ducts
Linear Models
Logistic Models
Processing
Research
Liberase

Keywords

  • Good manufacture practice
  • Human islet isolation
  • Islet of langerhans
  • North American Islet Donor Score (NAIDS)
  • Outcome parameters

ASJC Scopus subject areas

  • Biomedical Engineering
  • Cell Biology
  • Transplantation

Cite this

Effect of manufacturing procedures on human islet isolation from donor pancreata standardized by the North American islet donor score. / 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.

In: Cell Transplantation, Vol. 26, No. 1, 2017, p. 33-44.

Research output: Contribution to journalArticle

Yeh, CC, Wang, LJ, McGarrigle, JJ, Wang, Y, Liao, CC, Omami, M, Khan, A, Nourmohammadzadeh, M, Mendoza-Elias, J, McCracken, B, Marchese, E, Barbaro, B & Oberholzer, J 2017, 'Effect of manufacturing procedures on human islet isolation from donor pancreata standardized by the North American islet donor score', Cell Transplantation, vol. 26, no. 1, pp. 33-44. https://doi.org/10.3727/096368916X692834
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. / Effect of manufacturing procedures on human islet isolation from donor pancreata standardized by the North American islet donor score. In: Cell Transplantation. 2017 ; Vol. 26, No. 1. pp. 33-44.
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AU - Liao, Chien Chang

AU - Omami, Mustafa

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N2 - 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 ³65 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 ³400,000 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.

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