publication date: December 13, 2022
It is a ready-made medical device made of living cells and biomaterials, i.e. biological elements, and printed using 3D technology. It will primarily apply to patients with type 1 diabetes who experience severe complications. This is a huge breakthrough and an original idea of Polish scientists led by Dr. Michał Wszoła. This is an opportunity for patients as effective as transplantation, and at the same time less invasive compared to pancreatic islet transplantation. As a result, it will require neither a deceased donor nor immunosuppressive treatment.
The 3D bionic pancreas is an alternative to transplantation. Although, in the opinion of many doctors, this is the only available method for patients with type 1 diabetes with diabetic complications, which gives a chance for cure. After a successful transplant, the value of glycated hemoglobin returns to normal, and complications do not develop or their development is inhibited.
However, it is worth remembering that this method carries a very high risk. Serious perioperative complications may occur, therefore the potential group of patients who may receive a transplant is very limited. In fact, people for whom there is no other option are qualified for a transplant. On the other hand, in the case of the second variant of treatment, i.e. pancreatic islet transplantation, the effects are not as good as after transplantation of the entire organ, which also significantly limits the indications to a very narrow group of patients.
It should be mentioned that the number of donors is very small and definitely disproportionate to the needs of patients. For example, in 2018, 21 pancreas transplants and 1 pancreatic islet transplant were performed in Poland, and 10,000 patients were waiting for a transplant at that time. Currently, it is estimated that 20,000 patients need a transplant, and only about 40 pancreatic transplants are performed annually. This means that the actual possibilities of performing a transplant are very limited and entering a patient on the waiting list for a transplant does not mean that such an operation will be performed soon.
Another problem with transplantation is that the patient must take immunosuppressive drugs that inhibit the rejection of the transplant.
Therefore, the 3D bionic pancreas is an important and needed initiative in this regard.
How is a bionic pancreas created?
The first step is to perform a biopsy, during which stem cells are taken from the patient. These cells are then multiplied. The next phase is the transformation towards cells producing insulin and glucagon, i.e. the so-called pancreatic islets. Then bioprinting takes place using the 3D technique, in the process of which such a bionic pancreas is created. It is stored to assess whether it is safe for the patient and functional at the same time. If this assessment is positive, a transplant procedure is performed.
The world’s first bionic pancreas was printed in Poland using 3D technology. At the moment, the bionic pancreas consists of pancreatic islets embedded in a special biological bioink, which is to imitate the natural place of living in the pancreas. Around the pancreatic islets, Dr. Michał Wszoła’s team managed to print a vascular system to which an active flow was connected. The printed pancreas was placed in the bioreactor. Magnetic resonance imaging and CT scans were also performed to evaluate the inside of the pancreas. The vascular system was exactly as planned by the team of scientists on the printout, there were no displacements or errors – all vessels were reproduced as written in the computer program.
Assumptions about the operation of the 3D bionic pancreas
This organ consists of cells that produce insulin and glucagon directly into the bloodstream. The bionic pancreas imitates the natural production of insulin, which makes the response to high or low blood glucose levels natural. Therefore, it better prevents diabetes complications in patients. Animal tests were positive. The above assumptions have been implemented, thanks to which the research on the project has entered the clinical phase – the team is ready to perform transplants in humans and is just waiting for investors. These trials are expected to begin with type 1 diabetic patients with severe complications who currently have no other treatment options. They are the first to benefit from this innovative device. For each patient, such a pancreas is to be printed individually, which is to have a better impact on the patient during treatment.
In order for clinical trials to start, and thus the first bionic pancreas transplants to be carried out, the missing amount of EUR 9 million is needed.
Polish procedure of clinical trials in legal terms – basic information
A clinical investigation of a medical device is any study conducted on humans to discover or confirm the clinical effects of one or more investigational medical devices, or to identify the adverse effects of one or more investigational medicinal products, or to track the absorption, distribution, metabolism and excretion of one or more investigational medical devices, taking into account their safety and effectiveness.
A clinical trial is conducted taking into account that the rights, safety, health and well-being of clinical trial participants are superior to the interests of science and society. Clinical trials, including bioavailability and bioequivalence trials, are planned, conducted, monitored and reported in accordance with the requirements of Good Clinical Practice.
A clinical trial of a medical device may be started if the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products has issued a permit to conduct the trial and the bioethics committee has issued a positive opinion on the trial.
In order for such a permit to be issued, an appropriate application must be submitted in accordance with the Regulation of the Minister of Health of February 17, 2016 on template applications for clinical trials of a medical device or an active implantable medical device and on the amount of fees for submitting such applications. Relevant documents must also be attached to the application.
If the documents are complete and the permission of the President of the Office has been issued, one can proceed to the stage of clinical trials. However, if there is a need for a significant change in the clinical trial protocol or documentation concerning the investigational medical device, which affects the safety of clinical trial participants, a positive opinion of the Bioethical Committee and consent of the President of the Office should be applied for. The consent is issued within no more than 38 days from the date of submission of the application.
The sponsor shall inform the President of the Office and the Bioethics Committee which gave its opinion on the study about the completion of the clinical trial within 90 days from the date of completion of the clinical trial.
It should also be mentioned that the Medical Research Agency was established in Poland, whose task is to take care of the development of research in the field of medical sciences and health sciences. Medical Research Agency is an entity whose goal is to build an innovative healthcare system.
Clinical research on the 3D bionic pancreas
The problem with conducting such research in Poland is the use of living cells. This is due to the fact that it is not a classic medical device, but a borderline device. This does not change the fact that conducting such research is possible in the Polish legal system.