The device will be put through a clinical trial funded by a grant from the Juvenile Diabetes Research Foundation (JDRF). The initial trial will involve eight patients at the Uppsala University Hospital in Sweden who will use the new device for approximately two years to assess the safety, survival, and function of implanted pancreatic endocrine cells.
The device actually contains islets of Langerhans, cells that produce insulin and glucagon, which are meant to function together much like a healthy pancreas. Since living cells make a home inside the ßAir device, patients will have to keep the colony healthy similarly to the Tamagotchi by feeding it air and oxygenating it every 24 hours.
Replenishing the device is performed through two ports implanted under the skin. The replenishing device is very user friendly, requires minimal technical skills for operation, and has very few possibilities for incorrect operation, according to the Israeli company. The replenishing procedure takes just about two minutes and an alarm will be triggered if something has gone wrong.
Within the Bioreactor, the cells are implanted into a hydrogel structure that provides a comfortable environment for the cells to thrive. Furthermore, this structure provides a protection from the immune system, which means that patients do not need immunosuppressive therapy as would be necessary with a conventional islet transplantation.
As stated on the JDRF website, "The dream for everyone with type 1 diabetes (T1D) is to permanently restore their body's lost ability to produce insulin… JDRF is partnering with Beta-O2 in order to speed up the testing of ßAir, an implantable macroencapsulation system composed of an immune protection unit (about two and a half inches across) connected to ports through which oxygen can be periodically injected to support the survival of the enclosed beta cells or islets. Ensuring an adequate oxygen supply for encapsulated cells remains one of the biggest challenges for macroencapsulation devices. Balancing the need for immune protection with the need for an adequate oxygen supply is a tall order for most encapsulation device designs. The Beta-O2 approach may represent an ingenious solution."
Extensive pre-clinical studies demonstrated significantly strong results. ßAir has also experienced early success in the clinic. A 63-year-old patient in Europe with (T1D) received the implant and was followed for 10 months. Persistent graft function in the device was demonstrated, with regulated insulin secretion and preservation of islet morphology and function without any immunosuppressive therapy.
"Imagine if those with type 1 diabetes no longer had to worry about insulin injections or glucose levels. They could eat what they wanted, exercise as they wished and need not measure every step they took. This is the future that Beta-O2 envisions ßAir will help to create," said Dr. Dan Gelvan, Ph.D., chairman of the board of Beta-O2 and managing director of life sciences at Aurum Ventures. "There are two key factors that make ßAir different from other bio-artificial pancreases in development. ßAir provides protection from the host immune system, thus eliminating the need for immunosuppressive therapy and preventing what could otherwise be a fatal immune response of the patient to the transplanted cells. ßAir is also the only system that actively supplies oxygen and in more than sufficient quantities to the islet cells, one of the biggest consumers of oxygen in the body. Once every 24 hours, those with the implant are required to refill the air in the tiny device using a replenishing system which includes a dedicated injector. In addition, ßAir is able to support any type of cell source, which widens treatment possibilities."
Beta-O2 Technologies is a privately held company founded in 2004 and located in Rosh Ha’ayin, Israel, near Tel-Aviv.