Открытое пилотное исследование для оценки безопасности и эффективности трансплантации макро-капсулированных человеческих островков в биоискусственный поджелудок Beta-Air у пациентов с диабетом 1 типа

Краткое описание

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.