Encapsulated porcine neonatal islets were transplanted into 8 type 1 diabetic patients.
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Patients with high dose group could maintain HbA1c < 7% > 600 days with reduced hypoglycemic events.
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There is no PERV infection in all patients
Insulin dependent diabetes mellitus can be successfully treated by human islet cell transplantation. However the shortage of donated human pancreas is the major issue. Islet transplantation using clinical grade porcine pancreas is a promising treatment to alleviate the shortage of donated human pancreas.
In this study, we transplanted encapsulated neonatal porcine islets into 8 insulin dependent diabetic patients. There was no porcine endogenous retrovirus infection. All patients reduced HbA1c levels which indicated glycemic controls were improved.
Encapsulated neonatal porcine islet transplantation appears safe and efficacious to improve glycemic control for insulin dependent diabetic patients.
Abstract
Background
Allogeneic islet transplantation has become a viable option for the treatment of unstable type 1 diabetes. However, the donor shortage and the necessity of the immunosuppressive drugs are two major issues. To solve these issues, we performed islet xenotransplantation using encapsulated neonatal porcine islets without immunosuppressive drugs.
Methods
Two different doses (approximately 5000 IEQ/kg and 10,000 IEQ/kg) of encapsulated neonatal porcine islets were transplanted twice (total approximately 10,000 IEQ/kg and 20,000 IEQ/kg) into four type 1 diabetic patients in each group (total 8 patients).
Findings
In the higher dose group, all four patients improved HbA1c. This was maintained at a level of < 7% for > 600 days with significant reduction of the frequency of unaware hypoglycemic events.
Interpretation
The clinical benefit of islet xenotransplantation with microencapsulation has been shown.