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Cold ischemic time - the time measured from the point at which blood flow to the organ is stopped in the donor to the time at which the blood flow to the organ is restored in the recipient. [...] Rise in liver enzymes and puncture of the gallbladder are also possible events associated with the transplant procedure.16 5 Islet Transplantation for the Treatment of Type 1 Diabetes - An Update Immunosuppressive therapy One of the crucial components in the clinical islet transplantation program is the life-long use of immunosuppressive regimen to ensure survival of the allograft by addressing au [...] Islet transplantation has not been approved for marketing by the US FDA because of the current lack of information showing the safety, purity, potency, and effectiveness of the final product.44 Currently, the use of allogeneic islets for the treatment of type 1 diabetes is investigational and is only used in clinical trials under IND application.44 Furthermore, the classification of islet cells as [...] Methodological quality of the selected studies Although case series studies are generally considered as the lowest level of evidence, findings from this type of study are the main source of information about the safety and efficacy of islet transplantation. [...] When looking at the five most important criteria, only two of the trials were multicentre trials,46;53 indicating that generalizability of the findings from the majority of the studies is in question.