Clinical Trial

An Open Label, Pilot Investigation, to Assess the Safety and Efficacy of Transplantation of Macro-encapsulated Human Islets Within the Bioartificial Pancreas Beta-Air in Patients With Type 1 Diabetes Mellitus

Active, Not Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2014-02-13; most recent amendment 2026-04-27.
Status change: Recruiting → Active, Not Recruiting 2016-10-25
Trial Details
NCT Number NCT02064309
Lead Sponsor Uppsala University Hospital
Collaborators: Beta-O2 Technologies Ltd.
Conditions Long-standing Type 1 Diabetes Mellitus
Enrollment 4 participants
Start Date 2014-02
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-04-28