Periodic Reporting for period 2 - Micro Pancreas (Cure Diabetes by Injection of Micro Pancreas Cell Therapy)
Periodo di rendicontazione: 2022-03-01 al 2024-02-29
Betalin was founded to promote the development of the EMP as a novel islets’ transplantation therapy, Betalin plan is that our treatment could replace current NHS protocol, and help patients suffering from Diabetes to achieve normoglycaemia.
Diabetes is an ongoing and constantly growing concern in the developed world. Patients with Diabetes suffer from lack of insulin production. Insulin is a crucial hormonal “key” which allows glucose to enter red blood cells (haemoglobin) and be metabolised properly by the body. Without it, glucose remains in the blood and causes significant complications that can be both short term - seizures and fainting that could result in coma or even death, and long-term - stroke, heart disease, blindness, kidney failure and limb amputation.
Unfortunately, the most used solutions for diabetes are only managing solutions of the disease with many side effects. Lately, more and more scientist, including our own, looking for a different way to treat diabetes using cell therapy as the future therapy.
The vision of Betalin is to eliminate the need of insulin injections in diabetic patients using our technology of Micro Pancreas.
The Micro Pancreas has the following components: (1) a proprietary organ derived 3D scaffold, i.e. Micro-Organ Matrix (MOM); (2) Stem cell derived β-cells. After implantation under the skin (by injection), Micro Pancreas restores natural insulin production and blood glucose regulation, actually curing Diabetes. Micro Pancreas is a revolutionary regenerative micro-organ, based on cell therapy, that replaces the native human pancreatic endocrine function damaged in Diabetes
Micro Pancreas eliminates insulin dependency in diabetes patients, removing the need for daily and meal correlated injections, constant blood glucose monitoring and dietary constraints. Instead, patients get a biological implant by injection of Micro Pancreas, a micro-organ that generates insulin naturally in response to glucose, improving considerably day-by-day life of patients with diabetes, including children with Type 1 Diabetes and moreover, preventing the long-term complications caused by the disease.
Betalin technology outperforms contemporary standard of care solutions, such as insulin pumps or artificial pancreas that need maintenance and are cumbersome to wear, as well as islet transplantation by Edmonton Protocol, a procedure carried out by transplanting isolated islets, harvested from at least two donors, into the liver accompanied by immune suppression drugs and is used clinically today to treat most severe cases in few highly specialized medical centres. Micro Pancreas is applied by a simple procedure, not requiring hospitalization, and performed in outpatient clinics (not highly specialized hospitals).
Diabetes is an ongoing and constantly growing concern in the developed world. Patients with Diabetes suffer from lack of insulin production. Insulin is a crucial hormonal “key” which allows glucose to enter red blood cells (haemoglobin) and be metabolised properly by the body. Without it, glucose remains in the blood and causes significant complications that can be both short term - seizures and fainting that could result in coma or even death, and long-term - stroke, heart disease, blindness, kidney failure and limb amputation.
Unfortunately, the most used solutions for diabetes are only managing solutions of the disease with many side effects. Lately, more and more scientist, including our own, looking for a different way to treat diabetes using cell therapy as the future therapy.
The vision of Betalin is to eliminate the need of insulin injections in diabetic patients using our technology of Micro Pancreas.
The Micro Pancreas has the following components: (1) a proprietary organ derived 3D scaffold, i.e. Micro-Organ Matrix (MOM); (2) Stem cell derived β-cells. After implantation under the skin (by injection), Micro Pancreas restores natural insulin production and blood glucose regulation, actually curing Diabetes. Micro Pancreas is a revolutionary regenerative micro-organ, based on cell therapy, that replaces the native human pancreatic endocrine function damaged in Diabetes
Micro Pancreas eliminates insulin dependency in diabetes patients, removing the need for daily and meal correlated injections, constant blood glucose monitoring and dietary constraints. Instead, patients get a biological implant by injection of Micro Pancreas, a micro-organ that generates insulin naturally in response to glucose, improving considerably day-by-day life of patients with diabetes, including children with Type 1 Diabetes and moreover, preventing the long-term complications caused by the disease.
Betalin technology outperforms contemporary standard of care solutions, such as insulin pumps or artificial pancreas that need maintenance and are cumbersome to wear, as well as islet transplantation by Edmonton Protocol, a procedure carried out by transplanting isolated islets, harvested from at least two donors, into the liver accompanied by immune suppression drugs and is used clinically today to treat most severe cases in few highly specialized medical centres. Micro Pancreas is applied by a simple procedure, not requiring hospitalization, and performed in outpatient clinics (not highly specialized hospitals).
The main goals of the first period (P1) of the project were to mitigate some of the difficulties of the project – such as industrial adaptation of the MOM (scaffold production), establishing a clear route for accessing human islets for the project, optimisation of the Engineered Micro Pancreas (EMP) production and to increase the company’s knowledge on the market landscape and the positioning of the EMP within this landscape.
In P1, the development team achieved:
• Establishment of manufacturing process in line with ISO guidelines.
• Analysis of automation capabilities - mapping the current solutions in the market and evaluation of the potential ones that may fit the product.
• Identifying suitable suppliers for human islets, and clinical centres to perform the clinical trials.
• Working on regulatory documents needed to get an approval to start clinical trials.
• Establishment of BetalinUK in the campus of Leeds University campus and establishment of strategic alliances with key players in the diabetes and islets transplantation fields. These activities are mandatory in order to move forward with the project, and conduct clinical trials to test the EMP.
P1 activities were significantly impacted by delays due to COVID-19. In the initial phase of P2, we identified numerous challenges associated with the utilization of human islets. Consequently, we have postponed the clinical trials scheduled to take place in the UK, along with the planned activities for our UK subsidiary. In a significant strategic shift, Betalin opted to utilize stem cells for implantation onto the MOM, a move that could be considered pioneering beyond the current state of the art. However, this decision has led to a delay in commencing the clinical study and has hindered our progress in achieving Phase IB as outlined in the project plan. P1 activities suffered badly from delayed caused by COVID 19.
During the first part of P2 we recognised many issues related to the use of human islets and therefor have postponed the clinical trials planned to be in the UK and the planned activities for the UK subsidiary. As a major pivot Betalin decided on using stem cell to be implanted on the MOM (which may be considered as a move well beyond State of the Art). During P2 we completed an updated manufacturing process of MOM adjusted to support stem cell derived insulin secreting Beta cells completed. We also identified and characterized GMP compliant reagents for MOM manufacturing and identified of a reliable source of stem cells derived Beta cells. Betalin has conducted pre-clinical studies demonstrating efficacy of the product in a diabetic mouse model.
In P1, the development team achieved:
• Establishment of manufacturing process in line with ISO guidelines.
• Analysis of automation capabilities - mapping the current solutions in the market and evaluation of the potential ones that may fit the product.
• Identifying suitable suppliers for human islets, and clinical centres to perform the clinical trials.
• Working on regulatory documents needed to get an approval to start clinical trials.
• Establishment of BetalinUK in the campus of Leeds University campus and establishment of strategic alliances with key players in the diabetes and islets transplantation fields. These activities are mandatory in order to move forward with the project, and conduct clinical trials to test the EMP.
P1 activities were significantly impacted by delays due to COVID-19. In the initial phase of P2, we identified numerous challenges associated with the utilization of human islets. Consequently, we have postponed the clinical trials scheduled to take place in the UK, along with the planned activities for our UK subsidiary. In a significant strategic shift, Betalin opted to utilize stem cells for implantation onto the MOM, a move that could be considered pioneering beyond the current state of the art. However, this decision has led to a delay in commencing the clinical study and has hindered our progress in achieving Phase IB as outlined in the project plan. P1 activities suffered badly from delayed caused by COVID 19.
During the first part of P2 we recognised many issues related to the use of human islets and therefor have postponed the clinical trials planned to be in the UK and the planned activities for the UK subsidiary. As a major pivot Betalin decided on using stem cell to be implanted on the MOM (which may be considered as a move well beyond State of the Art). During P2 we completed an updated manufacturing process of MOM adjusted to support stem cell derived insulin secreting Beta cells completed. We also identified and characterized GMP compliant reagents for MOM manufacturing and identified of a reliable source of stem cells derived Beta cells. Betalin has conducted pre-clinical studies demonstrating efficacy of the product in a diabetic mouse model.
Betalin is pioneering the development of the Micro Pancreas, also known as EMP, a revolutionary Cell Therapy technology aimed at restoring insulin production for millions of patients worldwide. The Micro Pancreas represents an advanced cell therapy comprising a Micro-Organ Matrix (MOM) and human islets.
The Micro-Organ Matrix (MOM) is crafted from organic tissue with the original tissue cells thoroughly removed, minimizing the risk of rejection or immune response, unlike traditional biomaterial matrices used in manufactured solid organs. This specialized matrix provides a protective environment for implantation and has demonstrated superior performance in supporting implanted pancreatic islet cells.
In the realm of clinical applications, biomaterials and scaffolds implanted in the body serve diverse purposes such as cell transplantation, controlled drug release, continuous sensors, electronic pacing, and tissue regeneration. While most existing 3D cell culture systems rely on synthetic or biomimetic materials, they lack the complexity of the natural microenvironment. Betalin's MOM technology stands out as a unique 3D biologic scaffold that preserves the intricate tissue micro-environment, thus enhancing insulin secretion.
The strategic pivot undertaken during P2 represents a significant leap beyond the current state of the art, notably by pioneering the implantation of stem cells on a Biomaterial Matrix.
The Micro Pancreas is designed for straightforward implantation via a simple under-the-skin injection procedure using a larger-gauge needle, eliminating the need for invasive surgery. Following implantation, the Micro Pancreas promptly regulates blood glucose levels in the patient and maintains effectiveness for an estimated duration of 1-3 years. Additionally, repeat implantations of the Micro Pancreas offer patients the possibility of an extended period of normalcy in their lives.
lowing for a further period of normal life for the patient.
The Micro-Organ Matrix (MOM) is crafted from organic tissue with the original tissue cells thoroughly removed, minimizing the risk of rejection or immune response, unlike traditional biomaterial matrices used in manufactured solid organs. This specialized matrix provides a protective environment for implantation and has demonstrated superior performance in supporting implanted pancreatic islet cells.
In the realm of clinical applications, biomaterials and scaffolds implanted in the body serve diverse purposes such as cell transplantation, controlled drug release, continuous sensors, electronic pacing, and tissue regeneration. While most existing 3D cell culture systems rely on synthetic or biomimetic materials, they lack the complexity of the natural microenvironment. Betalin's MOM technology stands out as a unique 3D biologic scaffold that preserves the intricate tissue micro-environment, thus enhancing insulin secretion.
The strategic pivot undertaken during P2 represents a significant leap beyond the current state of the art, notably by pioneering the implantation of stem cells on a Biomaterial Matrix.
The Micro Pancreas is designed for straightforward implantation via a simple under-the-skin injection procedure using a larger-gauge needle, eliminating the need for invasive surgery. Following implantation, the Micro Pancreas promptly regulates blood glucose levels in the patient and maintains effectiveness for an estimated duration of 1-3 years. Additionally, repeat implantations of the Micro Pancreas offer patients the possibility of an extended period of normalcy in their lives.
lowing for a further period of normal life for the patient.