Um Estudo de Investigação Piloto de Marca Aberta, para Avaliar a Segurança e Eficácia da Transplantação de Isletos Humanos Macro-encapsulados no Bioartificial Pancreas Beta-Air em Pacientes com Diabetes Mellitus de Tipo 1

Resumo breve

The primary objective of this clinical investigation is to investigate the safety of implantation of the human islet containing device Beta-Air in type 1 diabetic subjects. The secondary objective of this clinical investigation is to investigate if the transplantation of macro-encapsulated human islets within the Beta-Air device can provide improved glycaemic control in type 1 diabetes patients with reduced incidences of hypoglycaemic episodes.