{"id":17957,"date":"2026-05-11T19:55:16","date_gmt":"2026-05-11T15:55:16","guid":{"rendered":"https:\/\/medscriptum.org\/?p=17957"},"modified":"2026-05-11T19:55:42","modified_gmt":"2026-05-11T15:55:42","slug":"bio-artificial-pancreas-and-a-new-era-for-diabetes-an-exclusive-interview-with-ekaterine-berishvili","status":"publish","type":"post","link":"https:\/\/medscriptum.org\/en\/bio-artificial-pancreas-and-a-new-era-for-diabetes-an-exclusive-interview-with-ekaterine-berishvili\/","title":{"rendered":"Bio-Artificial Pancreas and a New Era for Diabetes: An Exclusive Interview with Ekaterine Berishvili"},"content":{"rendered":"

For a century since the discovery of insulin, the primary mission of medicine has been patient survival and symptomatic management. Today, however, in the laboratories of the University of Geneva, science is pursuing a far more ambitious goal: eliminating insulin dependence as a given reality. Leading this revolutionary idea within the framework of the international VANGUARD<\/a> consortium is Georgian physician and scientist Ekaterine Berishvili. After years of intensive research, the project has reached a decisive milestone: preclinical studies have confirmed that a bioengineered construct can successfully integrate into the body and restore lost pancreatic function.<\/p>\n

What stage is the technology at today, and when will it become part of clinical practice? We present an exclusive interview with Professor Ekaterine Berishvili, who discusses the unique details that the global medical community has been anticipating with great interest.<\/p>\n

The VANGUARD project is the fruit of five years of intensive research. In science, results rarely come without obstacles. For you, what was the turning point when theoretical research transformed into a real, functional technology?<\/b><\/p>\n

I agree\u2014in science, results are generally rare, even setting obstacles aside. Any scientific research is based on a specific hypothesis which, in most cases, unfortunately does not prove true. Our project was distinguished by the fact that we had a very solid starting point; the research was based on pilot results obtained in the laboratory. By then, we had already developed several components of the construct that later became the core of VANGUARD. The VANGUARD consortium was built upon this successful experience.<\/p>\n

Furthermore, it was of immense importance that several powerful partners joined the consortium, all of whom have contributed greatly to today’s success. Our team included immunologists, cell biologists, diabetologists, and specialists in genetic and bioengineering. Six major European organizations worked day and night on this project, and I believe we have achieved a quite impressive result.<\/p>\n

Such were the beginnings from which our adventure started. I should clarify that the research actually lasted five and a half years. Due to the pandemic, a very difficult period began for the whole world, and especially for scientists; we were off track for almost a year because we couldn’t enter the laboratories to continue our work.<\/p>\n

Professor Berishvili, the term “functional cure” sounds very bold. To be specific for the patients: what stage is the technology at, and does it mean total freedom from insulin injections and constant glucose monitoring?<\/b><\/p>\n

First of all, it is necessary to emphasize one circumstance: at this stage, this technology has only been tested on small animals. Research has not yet been conducted on large animals or humans, so saying we have already reached the final goal is premature. This is a massive step toward defeating diabetes, but at this stage, it does not mean a complete cure for the disease.<\/p>\n

As for a “functional cure,” yes, this term implies that the patient should no longer require daily glucose monitoring or insulin injections. The main advantage of our construct is that it fully replaces the function of destroyed beta cells. As you know, beta cells are responsible for producing insulin; through our method, we introduce healthy cells into the body that integrate into the patient’s tissues and begin functioning independently.<\/p>\n

Within the scope of the study, implanting these constructs into diabetic mice resulted in a full recovery\u2014they required neither injections nor monitoring, as their blood sugar levels remained stably at normal marks. However, we must remember that Type 1 diabetes is an autoimmune disease. We cannot yet resolve the autoimmune condition itself, though we can fully restore the function of the lost cells.<\/p>\n

This is what we call a functional cure. I want to emphasize once more that these results have only been confirmed in small animals so far. We have a long road ahead to reach human application, but the step we have taken is so significant that it gives us great hope for the future.<\/p>\n

It is interesting to know how the issue of immune compatibility is resolved in this system. We read about “Amniogel” in the project description\u2014what makes this material unique and how does it protect the transplanted cells?<\/b><\/p>\n

The issue of immune compatibility in this system is quite complex. While it hasn’t been fully solved yet, we have reached a certain stage, which I will discuss in a moment.<\/p>\n

Regarding Amniogel specifically: this is a hydrogel derived from the fetal membrane of the placenta\u2014the amnion. This material has several advantages. First, it is an ethically sourced biomaterial, as the placenta and amniotic membrane are considered medical waste. At the same time, this material is unique by nature: for nine months, it is precisely what ensures the protection of the fetus from inflammation and rejection by the immune system.<\/p>\n

Amniogel is characterized by strong anti-inflammatory and immunomodulatory effects, but its most important property is the stimulation of new blood vessel development (angiogenesis). When transplanting any cell, it is critical how quickly blood vessels grow into it. A living cell needs nutrition and oxygen to survive, which is provided by blood circulation. If a vascular network is not formed quickly, the transplanted cells will lose viability.<\/p>\n

Furthermore, Amniogel creates the specific microenvironment necessary for cellular function. Cells receive vital signals from the so-called extracellular matrix. When cells are isolated from tissue, this contact is broken; Amniogel restores it. It is rich in the exact components characteristic of the pancreatic Islets of Langerhans and plays a decisive role in the proper secretion of insulin in response to glucose.<\/p>\n

Our research showed that Amniogel also creates a kind of shield. During observation, we saw that immune system cells (T-lymphocytes) pass through this barrier very slowly. This is especially important in the first critical days after transplantation when the body’s inflammatory reaction begins. Amniogel protects the cells from this initial assault.<\/p>\n

Interestingly, in this way, we turn medical waste into a unique medical preparation. The use of Amniogel is not limited to islet transplantation\u2014it could find many other applications in the future.<\/p>\n

Since we mentioned safety mechanisms, we cannot overlook the source of the cells themselves. Why was the focus placed specifically on pig cells, and how does this xenotransplantation method address the problem of donor shortages?<\/b><\/p>\n

Within the VANGUARD project, our goal was to test the hypothesis of whether we could create a construct that would fully replace the function of damaged cells. Creating a bio-artificial organ requires three main components: cellular material, a special scaffold (in our case, Amniogel), and a vascular network. As I mentioned, the rapid ingrowth of blood vessels is of vital importance, as without them, the construct would be destroyed due to oxygen and nutrient deficiency.<\/p>\n

Among these three components, the cellular material represents the greatest challenge. While the practice of transplanting Islets of Langerhans and whole pancreases already exists in medicine, the main obstacle is the acute shortage of donor organs. The number of patients far exceeds the number of available organs, which is why science has been searching for an alternative, inexhaustible source of cells for decades.<\/p>\n

Today, two main paths are being considered: stem cells and xenogenic (animal) material. Anatomically and physiologically, the pig is closest to humans. In recent years, the transplantation of pig organs and cells has moved from myth to reality and, likely, this method will soon be implemented in large-scale practice.<\/p>\n

Genetic engineering played a decisive role here. The animals we are talking about are specially bred, genetically modified pigs. American and European researchers modified about ten genes in their bodies that previously caused acute immune reactions and organ rejection in humans. Consequently, tissues obtained this way are much more compatible with the human body.<\/p>\n

This is why we used pig cells in VANGUARD. We believe this is one of the most promising and realistic alternatives to fill the donor organ deficit.<\/p>\n

The laboratory and preclinical stages were completed successfully. What is the next step? When is clinical testing planned to begin, and what are your expectations?<\/b><\/p>\n

Yes, the preclinical stage in small animals ended successfully\u2014we managed to cure mice of diabetes. Now a decisive phase begins, which primarily involves scaling the technology. Imagine how much a construct created for a 25-gram mouse must be enlarged to work in a human body weighing, say, 70 kilograms. To answer this question, it is essential to continue research on large animals. Only after clarifying these technical issues\u2014when we know the exact quantity, size, and optimal transplant site\u2014will we be able to move to the human testing phase.<\/p>\n

In parallel, another important process is underway: the standardization of Amniogel production under pharmaceutical conditions. Since this gel falls into the category of a pharmacological preparation, its manufacturing must comply with strict GMP (Good Manufacturing Practice) requirements. Fortunately, from the beginning, we developed a protocol compatible with these high standards. We are now working on setting up this certified production.<\/p>\n

As for the clinical trials themselves, we must understand that this is a long and complex process. The supreme principle in medicine is “do no harm,” so safety testing undergoes the most rigorous control by regulatory agencies.<\/p>\n

It is difficult for me to name a specific date at this stage, and I do not wish to give patients premature promises. The timeline of the research depends not only on us as scientists but also on regulatory requirements and necessary financial resources. However, the first and most important victory has already been won\u2014the technology has proven its effectiveness. Now everything is a matter of time and systematic work.<\/p>\n

When discussing such a large-scale innovation, its financial side is always relevant. Considering the prevalence of this pathology, everyone is naturally concerned with one main question: how accessible will this technology be?<\/b><\/p>\n

This issue is also of paramount importance to me, and I have published several articles on the topic. The existence of a technology does not inherently mean it is accessible, especially for countries like Georgia. My goal is for what we are creating to be equally accessible to people living anywhere in the world.<\/p>\n

If we look at history, scientists gifted insulin to humanity for a symbolic price, stating that this drug belongs not to them, but to the world. I belong to that category of scientists who believe that innovation should not be reserved only for the “elites” and the wealthy.<\/p>\n

The desire to increase accessibility was one of the reasons we chose pig cells. In our laboratory, we work in both directions: we have prototypes using insulin-producing cells derived from stem cells as well as those using xenogenic pig material. However, pig Islets of Langerhans are much cheaper. Differentiating stem cells takes 45 days, and the molecular solutions used in this process are very expensive. Furthermore, working with GMP standards and certified reagents involves costs that citizens of countries like ours cannot afford independently.<\/p>\n

Here, the healthcare system and proper insurance policies must play a decisive role. In developed countries, when a new method becomes a standard of treatment, the costs are covered by the state or the insurance system. A patient should not have to worry about how to pay for treatment out of their own pocket.<\/p>\n

In the case of Amniogel, the material itself\u2014the amniotic membrane\u2014is an absolutely accessible medical waste, and its processing method is quite simple. The final price will depend on what type of cells we use. In the academic sector, we try to reduce the technology to minimum costs, but at later stages, biotechnological companies get involved because academia lacks the resources needed to fulfill all regulatory requirements.<\/p>\n

Our main goal is for a functional cure to become a reality for every patient with diabetes and for this technology to be accessible in any country in the world.<\/p>\n","protected":false},"excerpt":{"rendered":"

For a century since the discovery of insulin, the primary mission of medicine has been patient survival and symptomatic management. Today, however, in the laboratories of the University of Geneva, science is pursuing a far more ambitious goal: eliminating insulin dependence as a given reality. Leading this revolutionary idea within the framework of the international […]<\/p>\n","protected":false},"author":12,"featured_media":17837,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1653],"tags":[5447,2987,2792],"class_list":["post-17957","post","type-post","status-publish","format-standard","has-post-thumbnail","category-interview","tag-bio-artificial-pancreas","tag-insulin","tag-type-i-diabetes"],"acf":[],"_links":{"self":[{"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/posts\/17957","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/comments?post=17957"}],"version-history":[{"count":1,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/posts\/17957\/revisions"}],"predecessor-version":[{"id":17959,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/posts\/17957\/revisions\/17959"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/media\/17837"}],"wp:attachment":[{"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/media?parent=17957"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/categories?post=17957"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medscriptum.org\/en\/wp-json\/wp\/v2\/tags?post=17957"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}