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Human Pancreatic Islet Isolation: Part I: Digestion and Collection of Pancreatic Tissue
Published on: May 26, 2009
Detection of microbial contamination during human islet isolation
Tatsuya Kin1, Shawn Rosichuk, A M James Shapiro
1Clinical Islet Transplant Program, University of Alberta and Capital Health Authority, Edmonton, Alberta, Canada.
Cell Transplantation
|April 18, 2007
Summary
Microbial contamination is common in pancreas transport solutions but largely eliminated during islet processing. Final islet products rarely show contamination, though de novo contamination can still occur even in current good manufacturing practice (cGMP) facilities.
Area of Science:
- Cellular biology
- Transplantation immunology
- Microbiology
Background:
- Current good manufacturing practice (cGMP) facilities ensure ultraclean environments for clinical-grade islet production.
- Islet transplantation is a vital therapy for immunosuppressed diabetic recipients.
Purpose of the Study:
- To monitor microbial contamination rates in islet products post-cGMP implementation.
- To identify sources and timing of contamination during islet processing.
Main Methods:
- Collected fluid samples from pancreas transport solution, post-decontamination, post-isolation, and final product.
- Performed bacterial, fungal, and mycoplasma cultures over 2-3 weeks.
- Analyzed contamination rates in relation to preservation, ischemia time, and procurement factors.
Main Results:
- 31% of transport solutions showed microbial contamination.
- Pancreas surface decontamination cleared 92% of initial contaminants.
- Six islet preparations showed de novo contamination during processing.
- Two transplanted islet products had positive post-transplant cultures without clinical infection.
Conclusions:
- While pancreas transport solutions pose a high contamination risk, processing significantly reduces it.
- De novo microbial contamination during islet processing remains a challenge even under cGMP.
- Final islet product contamination is rare, and post-transplant infections were not observed.
