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.
