1형 당뇨병 환자에서 바이오아트피칼 파이너스 베타-에어 내 마クロ엔켐벌루드 인슬렐의 이식 안전성 및 효과를 평가하는 오픈 레이블, 파일롯 조사

간략 요약

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.