Human Pancreatic Islet Production: From Research Protocols to Standardized Multicenter Manufacturing.

Abstract

Transient function following human pancreatic islet allotransplantation in a subject with type 1 diabetes was first reported over 25 years ago (1). Since then, clinical outcomes have been progressively improving, and nowadays islet transplantation represents a largely applied procedure that in experienced centers has a success rate similar to that of whole-pancreas transplantation (2,3). It might appear of little interest to discuss again the technical aspects of human islet manufacturing and to ask, is it justified to spend much time and many resources to further improve these procedures? The answer is yes, of course. Islet isolation and purification, that is islet manufacturing, are key elements in any islet transplant program. The ability to retrieve most of the islets from a human pancreas is the obvious prerequisite for the success of an islet transplant, as in vivo islet graft function significantly correlates with the number of transplanted islets (4). In addition, islet isolation procedures greatly affect islet quality in terms of viability, function, and proinflammatory conditions, all factors associated with in vivo islet graft function (5,6). The optimization of islet production will also lead to an improved cost efficacy of the overall islet transplant programs, which is now among the major limiting factors for the wider application of this procedure. A detailed …