It’s estimated that in Poland alone, there are more than two and a half million diabetic patients, 200,000 of which are patients with type I diabetes. According to WHO’s statistics, by 2030 these numbers will double. Chronic insulinotherapy with constantly improved insulin pumps and systems for continuous glycemic measurement is a very good combination for a large part of patients. For the present, the only way to achieve a complete cure is to transplant the pancreas or, to a lesser extent, transplantation of islets of Langerhans. However, these methods are difficult and not deprived of numerous drawbacks, such as the shortage of organs for transplantation, chronic immunosuppression or the risk of surgical complications after pancreas transplantation. To meet the difficulties posed by the current concept of combating illness, a new idea emerged. The idea of creating a bionic pancreas
If the program succeedes, what we of course count on, in 4-5 years scientists will be prepared to carry out first trials with the participation of patients. We can see that many diabetics look at our work with hope, giving us strength and willingness to act. I would like to point out that this type of research is unique on a global scale. Moreover, Polish Bionic Consortium is among the leaders of centers dealing with this subject.
Michał Wszoła MD, PhD
Why do we need a bionic pancreas?
The assumption of the project is to create a tailor-made pancreas. So far there have been two main ways to deal with diabetes.
The first, based on pharmacology, includes the regular administration of insulin called intensive insulinotherapy. This method does not guarantee prevention of the development of secondary complications, nor does it inhibit the progression of diabetes. Insulin therapy is only a temporary alternative.
The second and in fact the only path leading to complete cure is a pancreas or islets of Langerhans transplantation. This method of treating diabetes does not eliminate all problems. Statistics are also cruel in this case. In Poland, about 10.000 people should be qualified for this type of transplant, whereas only 40 operations are performed annually on average. The main limitation affecting these frightening data is the shortage of organs for transplantation.
It is commonly known that although every year the state of knowledge of Poles improves, and the number of transplants is growing, the demand for organs exceeds the amount that can be obtained from donors. In addition, after pancreas transplantation, the operation itself carries the risk of surgical complications, and the continuation of life after both islets of Langerhans and pancreas transplantation is associated with the continuous intake of immunosuppressive drugs. The pancreas created from its own transformed stem cells eliminates these two major problems.
In the face of the situation a group of Polish scientists under the leadership of the transplant surgeon Michał Wszoła MD, PhD attempted to find a more effective way to help the ever-growing number of people affected by diabetes. They put on a unique project on a global scale, i.e. the bionic pancreas.
In October 2015 of Foundation’s of Research and Science Development initiative, the BIONIC consortium was established and it consists of:
- Foundation of Research and Science Development together with a team of Michal Wszola MD, PhD as a consortium leader.
- Nencki Institute of Experimental Biology together with a team of prof. Agnieszka Dobrzyn.
- The faculty of Material Science of the Warsaw University of Technology under the directorship of prof. Wojciech Swieszkowski.
- Center for Biostructure Research of Warsaw Medical University under the directorship of prof. Artur Kaminski
- Jesus Child Hospital
- Medical clinic MediSpace Ltd.
The consortium implements the project “3D bioprinting of scaffolds using pancreatic islets or insulin producing cells in order to create bionic pancreas”. After receiving funding from the National Center for Research and Development in January 2017 under the STRATEGMED III program, the work on the bionic pancreas started in full swing, and what seemed to be the sleep of a dreamer has become a hard fact.
The goal of the project is to create a functional pancreas. One that can be transplanted to the patient without major problems. It will enable people affected by diabetes to function normally, and more importantly prevent the development of secondary complications, which are the causes of most deaths.
Bionic pancreas is an organ made of biological elements, including cells from the patient, which eliminates the need for immunosuppression. Stem cells collected from the patient are subsequently placed into a complete organ using engineering and mechatronics. The innovation of the project is based on the use of the latest technologies and pioneer research on the human body, resulting in the unique composition of the bio ink.
Our ‘pancreas’, in contrast to the bony bioprint that is nowadays coming into the clinic, is to include not only scaffolding elements but also living cells and pancreatic islets along with the vascular system. It will ensure maintenance and enable their proper functioning in this environment. Another advantage of this innovative project is that after transplanting previously isolated stem cells from adipose tissue, and programming them so that they are able to secrete insulin and glucagon, they will become a completely new type of cells. It will be an autologous graft.
For several years now, the team of prof. Agnieszka Dobrzyń from the Nencki Institute of Experimental Biology has been refining the model of transformation of human stem cells towards cells producing insulin and glucagon which will be another milestone in achieving the goal. In August 2018 it was possible to overcome another obstacle, which was the purchase of a specialized 3D printer, which allowed for sterile printing of pancreatic petals, and cost no less than PLN 140,000. Thanks to this, the way to the goal is open. The next stage of the project implementation is to start at the turn of 2018/2019 and it will include preparations for the first animal trials.
The benefits of the development of medicine are unquestionable, but how will it look for the average patient? Bionic pancreas is primarily aimed at preventing the development of further complications in patients struggling with diabetes. First, the program would cover people who would potentially be eligible for pancreas transplantation. These are patients who have already had severe complications, so the transplant provides a real guarantee of blocking of secondary diabetes complications. In addition to the priority aspect of saving human life, the additional benefit of a bionic pancreas could be the reduction of health care expenses. In Poland, these expenses are over 9% total outlays on health care which gives PLN 2.5 billion a year, one-fifth of this sum is for the treatment of diabetes-related complications. Implementation of the project assumptions could significantly reduce both financial outlays for the treatment of patients suffering from complications and the costs of immunosuppressive treatment. Of course, over time, the target group of will expand while improving patients’ quality of life.
What stage are we at?
On March 14th we printed the world’s first prototype of a bionic pancreas with vascular system. At the moment our bionic pancreas consists exclusively of alpha and beta animal pancreatic islets producing glucagon and insulin, submerged in a special bioink to imitate the natural place of living in the pancreas. We managed to print a vascular system around islets, to which we connected the active flow. We placed the printed pancreas in a bioreactor. We have also performed magnetic resonance and CT scans to evaluate our prototype from the inside. The results of these tests showed that we reproduced all the vessels exactly as we designed it in a computer program. This year we are planning two stages of research on small and large animals. Thanks to them we will gain the necessary knowledge about the biological behavior of our bioink and bionic pancreas in the living organism. Moreover, we will also evaluate the functionality of the printed organ.