First-in-Human
In 2012, a 63-years-old German patient affected by T1D for about 40 years was implanted with the βAir device at the Technische Universität in Dresden, Germany. He was Followed-up for a period of 10-months.
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
• At the end of 2014, four patients who met the study criteria were recruited into an open labeled, pilot investigation study which aimed to evaluate the safety and efficacy of the ßAir BAP device containing donor human IOL.
• The study was conducted at Uppsala University Hospital in Sweden.
• The principal investigators were Prof. Per-Ola Carlsson and Prof Olle Korsgren, both full professors at the Department of Medical Sciences, Uppsala University.
• Patients were implanted with the βAir BAP containing marginal doses of donor pancreatic islets for periods of 4-6 months.
• Good clinical signals were obtained in this study that permitted the design of our second generation human type device.
Beta O2 Technologies is developing a 2nd generation device that designed specifically to adapted for stem cell clusters and will allow to continue to an additional human trial in the near future.
Intact islets morphology and normal distribution of alpha and beta cells
