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Presenter: Gregory S., Korbutt, Edmonton, Canada
Authors: Gregory S. Korbutt
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Islet quality assurance – from the farm to the patient regulatory issues in islet xenotransplantation
Gregory S Korbutt
University of Alberta & Alberta Diabetes Institute, Edmonton, Canada
Patients with brittle type 1 diabetes can now be protected from severe hypoglycemia and improved glycemic stability following islet transplantation. However, widespread application of this treatment will necessitate the need to develop an alternative to human donor islets. Studies have reported successful transplantation of porcine islets from fetal, neonatal, and adult porcine pancreases. In addition to studies in rodents, fetal porcine islets have been isolated from pigs of gestational age 60 to 69 days have been transplanted into patients with type 1 diabetes, whereas neonatal and adult porcine islets have been implanted into diabetic non-human primates. Therefore, xenotransplantation of porcine islets isolated from either fetal, neonatal, or adult animals have many strengths and are becoming closer to clinical application. This presentation will provide recommendation for regulatory issues involved in future clinical studies using xenogeneic porcine pancreatic islet cell products for the treatment of type 1 diabetes. Porcine islet product release criteria will also be presented that will be helpful in establishing the safety (endotoxin, sterility), identity/purity (cell composition), quantity (islet equivalents, cell number), vitality (membrane intactness), and potency (insulin secretory capacity) of biological porcine islet cell products.
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