Engineering a solution to type 1 diabetes

Type 1 diabetes is a growing health concern that substantially impacts the health and well-being of more than nine million people worldwide. Although insulin injections have been a treatment option for over 100 years, the disease is still associated with multiple comorbidities that significantly affect patient health. Moreover, people living with diabetes are forced to continuously monitor their blood sugar levels to avoid hyper- or hypoglycemic episodes. We spoke to Fluicell's CTO Gavin Jeffries to learn more about how Fluicell is building tissues to engineer a solution to type 1 diabetes.

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Fluicell is using its tissue platform, Nexocyte, to create engineered pancreatic islet implants with the aim to provide a long-lasting treatment for type 1 diabetes. Could you elaborate on Fluicell's approach and its potential impact?

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Absolutely. At Fluicell, our goal is to develop a type 1 diabetes treatment that can restore glycemic control without the need for immunosuppressants or reliance on scarce donor materials. Our Nexocyte platform enables us to create engineered pancreatic tissue that responds to glucose, mimicking some of the natural functions of the pancreas. With this approach we aim to establish an effective solution for people living with diabetes.

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It is difficult to overstate the importance of current diabetes treatments, based on insulin injections, and the positive effects they have had on the health and well-being of people living with the disease. However, these injections only treat parts of the disease, and many patients struggle to maintain healthy blood sugar levels, with significant health implications as a result. Add to this the negative impact on the quality of life, from constantly having to monitor blood sugar levels. All of this creates a need for new treatments, without the drawbacks associated with current therapies, which we at Fluicell are working to fulfill using our technology.

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Early this year, Fluicell both announced successful results from the company's initial in vivo study and that Fluicell is commencing development of type 1 diabetes therapeutics based on induced pluripotent stem cells (iPSCs). What have been your main focus areas and how has the development work progressed since these announcements?

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Since the announcements of our tolerance tests, our primary focus has been on solidifying and diversifying our approach. While iPSCs are a crucial part of our strategy, we are also exploring other stem cell avenues, whilst additionally developing upon the precision cell patterning for optimal insulin response. We've been investigating scalable solutions based on our in vivo findings, ensuring we consider the robustness of the implant casing for easier transplantation processes. Our results so far are very encouraging, and I am enthusiastic about our current trajectory, which I believe will strengthen our position and our therapeutic approach even further.

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Precision-printed induced pluripotent stem cells (iPSCs)

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What role does the Nexocyte platform play in Fluicell's therapeutic development program?

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The Nexocyte platform is fundamental to our development program. In biological tissues, cells are not randomly arranged; they follow specific patterns and orientations that are essential for proper function. Nexocyte allows us to replicate these biological patterns by starting with the basic building blocks, the cells. Essentially, we can place cells right where they need to be, to perform their correct function within the tissue, rather than relying on random assembly. This capability enables us to design tissues tailored to specific therapeutic needs, potentially going beyond natural arrangements to enhance treatment efficacy.

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How does Fluicell's technology differ from other approaches to type 1 diabetes treatment, and what are its key benefits?

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Unlike other therapeutic approaches that rely on cell aggregation or self-assembly, our technology allows us to design and build therapeutic tissue at the cellular level. We have control over both the types of cells and their arrangement within the device. Additionally, we can fine-tune the microenvironment and incorporate bioactive elements within the construct. This precision control offers significant advantages in creating more effective and tailored treatments for type 1 diabetes.

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Today, type 1 diabetes can be treated using transplanted pancreatic islets that are obtained from deceased donors with very good results, often resulting in insulin independence for extended periods. However, this type of therapy also requires simultaneous treatment with immunosuppressive drugs, which is a significant drawback. This need for immunosuppressants also applies to many type 1 diabetes cell therapies that are now in development, where insulin-producing cells are injected into the patient. What we at Fluicell are doing, is instead to encapsulate engineered islets in an implantable material, that is meant to shield the cells from the patient's immune system. Our unique technology lets us create the islets directly as part of the implant, which creates an advantage compared to many other technologies out there. In the end, an important development goal for us is to create an implant that is isolated from the immune system, but at the same time is permeable to nutrients and hormones such as insulin and glucagon.

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Over the past year, there have been several new initiatives to advance the Advanced Therapy Medicinal Products (ATMP) sector, both in Sweden and internationally. How can Fluicell's therapeutic development benefit from these broader initiatives?

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Diabetes is a significant global health issue, and developing effective therapeutics requires collaboration across the field. Initiatives in the ATMP sector are crucial for regulatory approval pathways and providing small companies with access to GMP (good manufacturing practice) compliant facilities. We actively engage with organizations like ATMP Sweden and other networks to stay at the forefront of these discussions. This engagement helps us leverage infrastructure and resources that are essential for demonstrating and promoting our core offerings within the sector.

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Finally, how do you plan to advance the project going forward, and what should people interested in Fluicell's type 1 diabetes program keep an eye out for?

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Our core approach is to establish a robust method using the Nexocyte platform combined with our unique expertise to generate a therapeutic tissue capable of responding to stimuli like a natural pancreas. Moving forward, we aim to increase the complexity of our models and validate the utility of our tissues. This will involve creating more physiological human disease models for toxicology and efficacy screenings. Fluicell has active programs in both therapeutics and in vitro models, and advancements in one area often feed into the other.

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