Scientists working within VANGUARD—an international consortium funded by the European Union—and led by Georgian Professor Ekaterine Berishvili, have published the results of a critical preclinical trial for a bio-artificial pancreas designed to treat type 1 diabetes.
The study, published in the prestigious scientific journal Trends in Biotechnology, provides solid scientific proof-of-concept for the technology’s efficacy and confirms that the final product has successfully passed laboratory testing.
At this stage, the scientists succeeded in creating thin, disc-shaped implants that are already fully vascularized prior to transplantation into the body, meaning they feature a pre-formed, functioning microvascular network. The study demonstrated that transplanting these constructs into extrahepatic sites—specifically subcutaneously and into the omentum—of diabetic models ensured the long-term restoration and stable maintenance of normal blood glucose levels (normoglycemia). Achieving this in these specific sites had previously been an unresolved challenge due to the scarcity of blood vessels.
The new research revealed several unique properties of the implant, including the capacity of the innovative Amniogel (a hydrogel derived from the human amniotic membrane) used to encapsulate the islet cells to restore the vital signaling cues that cells typically lose during the isolation process.
Furthermore, laboratory observations (in vitro) demonstrated a novel immunoprotective effect for the first time: Amniogel significantly retards the migration of the body’s cytotoxic immune cells, providing an additional safeguard for the implant’s protection and survival.
Crucially, the entire technological manufacturing process was designed from the outset in compliance with international GMP (Good Manufacturing Practice) standards, rendering it a product fully prepared for clinical scaling.
As the authors note, the highly successful completion of this preclinical phase greens-lights the next phase of the project, with the team already actively working on upscaling production to fully align the device with the rigorous requirements needed to initiate human clinical trials.
