Tissue dissociation enzymes for isolating human islets for transplantation: factors to consider in setting enzyme acceptance criteria

• Published in: Transplantation Vol. 91; no. 2; p. 137
• Main Authors: McCarthy, Robert C, Breite, Andrew G, Green, Michael L, Dwulet, Francis E
• Format: Journal Article
• Language: English
• Published: United States 27.01.2011
• Subjects: Clostridium histolyticum - enzymology; Clostridium histolyticum - genetics; Endopeptidases - metabolism; Endopeptidases - pharmacology; Enzymes - metabolism; Enzymes - pharmacology; Enzymes - standards; Histological Techniques - methods; Histological Techniques - standards; Humans; In Vitro Techniques; Islets of Langerhans - anatomy & histology; Islets of Langerhans - drug effects; Islets of Langerhans Transplantation - methods; Islets of Langerhans Transplantation - standards; Microbial Collagenase - genetics; Microbial Collagenase - metabolism; Microbial Collagenase - pharmacology; Practice Guidelines as Topic - standards; United States; United States Food and Drug Administration; United States
• ISSN: 1534-6080
• DOI: 10.1097/tp.0b013e3181ffff7d

Tissue dissociation enzymes are critical reagents that affect the yield and quality of human pancreatic islets required for islet transplantation. The United States Food and Drug Administration's oversight of this procedure recommends laboratories to set acceptance criteria for enzymes used in the manufacture of islet products for transplantation. Currently, many laboratories base this selection on personal experience because biochemical analysis is not predictive of success of the islet isolation procedure. This review identifies the challenges of correlating results from enzyme biochemical analysis to their effectiveness in human islet isolation and suggests a path forward to address these challenges to improve control of the islet manufacturing process.