Trials / Active Not Recruiting
Active Not RecruitingNCT02064309
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
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Uppsala University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Beta-Air device for encapsulation of transplanted human islets |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2025-05-01
- Completion
- 2025-05-01
- First posted
- 2014-02-17
- Last updated
- 2024-12-05
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT02064309. Inclusion in this directory is not an endorsement.