Date: 2014-10-21
Type of information: Treatment of the first patient
phase:
Announcement: treatment of the first patient
Company: Beta-O2 (Israel)
Product: ßAir bio-artificial pancreas
Action
mechanism: ßAir is composed of an immune protection unit, 68 mm in diameter and 18 mm wide, connected to two ports, also implanted under the skin, just under and to the right of the naval. The encapsulation contains islets of Langerhans, with its main constituent the beta-cells, which provide the insulin production in the body. Patients are to inject oxygen, once daily, into one of the two ports connected to the implant. This is done using ßAir\'s oxygenation system which automatically measures and calculates the required amount of oxygen.
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country: Sweden
Trial details:
Latest
news: * On October 21, 2014, Beta-O2 announced that the first patient participating in the company\'s first broad study of the ßAir Bio-Artificial Pancreas has been successfully implanted. ßAir is in development as a treatment and a potential cure for type 1 diabetes (T1D). Eight participants who meet the study criteria will be enrolled in the trial at Uppsala University Hospital in Sweden. Last month, JDRF awarded Beta-O2 a grant to fund half of the $1M, two-year, open label, pilot investigation which will evaluate the safety and efficacy of implanting the ßAir macro-encapsulation with human islets of Langerhans. "The implant procedure took less than an hour. The patient remained hospitalized for four days thereafter for observation and was then discharged. Until day 180 following implantation, the patient will, among other protocol duties, be required to return to the clinic for monthly check-ups. On day 181, ßAir will be explanted from the patient, who will continue to be followed for another 180 days," said Dr. Per-Ola Carlsson, principal investigator of the ßAir study, professor at the Department of Medical Cell Biology, and the Department of Medical Sciences, Uppsala University.
