Community Research and Development Information Service - CORDIS

H2020

Io-EMP Report Summary

Project ID: 790461

Periodic Reporting for period 1 - Io-EMP (Tissue-derived acellular micro-scaffold technology reducing or eliminating diabetics’ dependence oninsulin therapy)

Reporting period: 2017-11-01 to 2018-02-28

Summary of the context and overall objectives of the project

Diabetes is an ongoing, and constantly growing concern in the developed world, with improving diagnostics technology showing that it is an increasing problem worldwide. Between 1980 and 2014, the rate of diabetes incidence almost doubled from 4.7% to 8.5%. In 2015, diabetes directly caused an estimated 1.6 million fatalities with a further 2.2 million linked to complications of high blood glucose, with higher mortality in low- and middle-income countries. Diabetes is classified by two types:

• Type 1 Diabetes (T1D): Formerly known as childhood-onset, juvenile, or insulin-dependent diabetes, Type 1 is the rarer form of diabetes (estimated 10-15% of diabetics, up from 5-10% in 2014, potentially due to confirmation & awareness bias in diagnosis). It is characterized by the patient’s inability to produce insulin in their own pancreas. The cause is unknown, but development of Type 1 has been linked to traumatic events such as injury, infection, or inflammation of the pancreas, and to immune system dysfunction (autoimmune causes). Contemporary knowledge can neither prevent nor cure Type 1 diabetes.
• Type 2 Diabetes (T2D): Formerly referred to as adult-onset or non-insulin-dependent diabetes, Type 2 is the more common form of diabetes mellitus, characterized by underperformance of insulin produced in the patient’s pancreas. This underperformance can be due to underperformance of Islet Cells, or a resistance to insulin in the patient’s body. Type 2 can be related to lifestyle, such as smoking or being overweight.

The key in both cases is inadequacy or total lack of insulin in the body. Insulin is crucial as the hormonal “key” which allows glucose to enter red blood cells (haemoglobin) in the human body. Inability to produce insulin, or underperforming insulin leads to elevated blood glucose (bG) levels, which causes damage to nerves and blood vessels both due to the relatively large size of glucose molecules in the bloodstream, and the toxic by-products of glucose existence and metabolism in the body without insulin. High blood glucose (hyperglycaemia) is caused by the body being unable to process glucose by absorbing it into haemoglobin, due to the absence or underperformance of insulin. This causes the body to resort to consuming other resources, such as fats and proteins. This produces ketones, and in severe cases of hyperglycaemia, enough ketones are generated to alter blood pH. This is known as diabetic ketoacidosis (as pH is lowered and blood becomes acidic) and is a life-threatening condition.

Complications which can arise from diabetes include lower extremity amputation, cardiovascular and cerebrovascular disease, blindness (diabetic retinopathy), and nerve damage (diabetic neuropathy). Diabetes is also the leading cause of renal disease (diabetic nephropathy) in the developed world.

EMP is an Engineered Micro-Pancreas. It comprises the following main components:
1) The Micro-organ Matrix
2) Isolated Pancreatic Islet Cells

The EMP (engineered micro-pancreas) is implanted using a simple procedure, wherein the patient is provided with a local anaesthetic and the combined product is injected using a larger-gauge needle or implanted subcutaneously. The procedure, overall, does not require any more invasive surgery than a simple biopsy would. After implantation, the EMP will lead to immediate regulation of bG levels in the patient, and last for an estimated two years. After this the procedure would be repeated, allowing for a further period of normal life for the patient.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

An interview with a newly-diagnosed diabetes patient.

Extensive market research & design of a clinical trial and commercialisation plan.

Fully-expanded product development plan through to post-market surveillance of the product.

Identification of go-to-market strategy.

Identification of non-drug means of regulating immune response to prevent immune-rejection of the implant.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Betalin Therapeutics' proprietary technology is a biological micro-environment for supporting the harvested islets. The combination of the harvested cells and the proprietary micro-environment is called Engineered Micro-Pancreas (EMP).

ANTICIPATED ADVANTAGES OF BETALIN THERAPEUTICS' SOLUTION

→ Fewer harvested cells will be required for each transplant, which means more than 5 times as many patients can be treated from the same number of harvests and significantly lowering the cost of each transplant
→ The transplants will be more successful because harvested cells thrive in the micro-environment of EMPs and in turn, integrate into the recipient's body much more readily
→ The transplants will also be more effective as the insulin secreted from EMPs is better regulated and longer-lasting than insulin from islets alone
→ While at first the same immuno-suppressants as currently prescribed in the Edmonton Protocol will be used, the next generation of EMPs will incorporate stem cell therapy and additional technologies such as encapsulation, making immuno-suppressants unnecessary

Betalin Therapeutics' EMPs are a technological breakthrough that has the potential to improve the lives of millions of people each year.

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