Grant for the 3D Bioprinted Bionic Pancreas as a Therapy for Type 1 Diabetes
The project is co-financed by the European Union through the European Regional Development Fund under the European Funds for a Modern Economy Programme.
The Bionic Pancreas-ATMP®
(Advanced Therapy Medicinal Product) developed by our team is an advanced 3D-bioprinted organ composed of a three-dimensional cellular scaffold and a functional vascular network. Both components are fabricated using proprietary 3D bioprinting technologies and patented bioinks that provide an optimal microenvironment for pancreatic islets obtained from donors or derived from a patient’s own cells.
The Bionic Pancreas-ATMP® can be bioprinted on demand and safely preserved for up to one week in a dedicated bioreactor system. The ResearchLine™ Bioreactor maintains controlled tissue culture conditions and enables precise evaluation of the printed organ’s quality, functionality, and safety prior to transplantation.
The bioprinted bionic pancreas is capable of autonomous, physiological secretion of insulin, glucagon, and C-peptide in a manner consistent with the function of a naturally transplanted donor pancreas.
Project value: PLN 16,994,307.96
European Funds contribution: PLN 10,395,499.94
Project duration:
January 1, 2025 – October 31, 2029
Project Objective
The objective of this project is to develop the world’s first fully functional, 3D-bioprinted Bionic Pancreas — ATMP® (classified as a cATMP, Combined Advanced Therapy Medicinal Product) intended for transplantation in patients with advanced type 1 diabetes or chronic pancreatitis.
Polbionica is a leading Polish company in the field of 3D bioprinting and biomaterials. The company brings together highly qualified researchers, scientists, and medical professionals whose mission is to improve the lives of patients with type 1 diabetes and chronic pancreatitis.
The innovation of this solution lies in the application of advanced 3D bioprinting technology to restore the body’s natural ability to regulate blood glucose levels. This approach has the potential to provide long-term independence from insulin injections while addressing the critical shortage of transplantable organs.
The Bionic Pancreas — ATMP®, featuring a fully vascularized structure, has successfully completed preclinical studies in large animal models (pigs), demonstrating strong results. The technology is now ready to advance into first-in-human clinical trials to evaluate its therapeutic efficacy.
A key milestone of the project will be the initiation of the first clinical trial involving patients with type 1 diabetes or chronic pancreatitis, aimed at validating the bionic pancreas as a fully functional transplantable organ.
In parallel, we plan to obtain CE marking for our proprietary bioinks as Class III medical devices and for the bioreactor as a Class IIa medical device. This will confirm compliance with European safety, health, and environmental standards. Achieving these certifications will enable market authorization for cATMP-based solutions, allowing commercialization of organ bioprinting systems across the
European market, targeted for 2028.
