In 2012, a 63-year-old German patient with type- 1diabetes (T1D) was transplanted with the βAir device. The patient was followed for 10 months at the Technische Universität in Dresden, Germany.
Persistent graft function in this device was demonstrated, along with regulated insulin secretion and preservation of islet morphology and function without any immunosuppressive therapy.
Phase I Safety/Efficacy Study
Eight patients who meet the study criteria will be enrolled in a two-year, open label, pilot investigation which will evaluate the safety and efficacy of implanting the ßAir macro-encapsulation with human islets of Langerhans. Enrollment is nearly complete.
The study is being conducted at Uppsala University Hospital in Sweden.
The principal investigator is Dr. Per-Ola Carlsson, professor at the Department of Medical Cell Biology, and the Department of Medical Sciences, Uppsala University.
Four patients have been implanted thus far with the βAir Bio-artificial Pancreas. The first patient in the study was implanted in October 2014. (Click here to view press release).