Diabetes and Insulin
The various cells of the Islets of Langerhans in the pancreas work in concert to help regulate body metabolism and blood physiology. In particular, beta cells in the pancreas are primary regulators of blood sugar. When blood sugar goes up, after a meal for example, beta cells respond by releasing insulin, which in turn acts on muscles and other organs and tissues to encourage uptake of sugar from the blood. Sugars are used by organs and tissues as fuel to keep the body's systems running properly. read more...
In Type 1 Diabetes, and some cases of Type 2 Diabetes, beta cells stop working correctly and/or are mistakenly killed by the body's own immune system in a process called autoimmunity. In these cases, self-injected pharmaceutical insulin can be used to control blood sugar, and to keep sugar moving out of the blood into the body's organs and tissues. However, the use of pharmaceutical insulin requires regular monitoring of the diabetic patient's blood sugar through finger pricks (to collect drops of blood for measuring). Also, it can be difficult to get the timing and dose right for insulin self-administration, as multiple factors need to be taken into account including the anticipated amount and type of food to be eaten and anticipated activity level for the next several hours. If the insulin dose is not high enough, sugar will not be sufficiently cleared from the blood, a condition known as hyperglycemia. If the insulin dose is too high, there is the opposite risk of hypoglycemia, which can be dangerous, even deadly if not addressed immediately. If blood sugar is not controlled tightly, chronic hyperglycemia associated with diabetes leads to long-term complications such as blindness (retinopathy), numbness (neuropathy), kidney damage (nephropathy), and blood vessel problems that can lead to heart attacks or foot ulcers ultimately ending with limb amputations.
Benefits and Risks of Intensive Insulin
Starting in the 1980s, clinical studies have systematically examined the effects of intensive insulin therapy (3-4 injections of insulin per day or continuous subcutaneous insulin infusion) to maintain relatively normal blood sugar levels, relative to conventional treatment (1-2 injections per day). While intensive treatment requires greater discipline on the part of the patient, the clinical studies have shown that it can reduce the long-term complications associated with chronic hyperglycemia. However, hypoglycemic events remain a problem with this approach. read more...
ViaCyte's Cell Replacement Therapy
As beta cell loss is the primary pathogenesis of insulin-dependent diabetes, the disease is a great candidate for cell replacement therapy. To this end, ViaCyte's lead cell therapy product, called Pro-Islet, is being developed to provide replacement beta cells for diabetes. Pro-Islet cells for medical or clinical use are expected to provide the same types of benefits as intensive insulin therapy but without the trouble of frequent blood sugar monitoring and insulin injections, and without the risk of unsafe hypoglycemic events. read more...
Because Pro-Islet is comprised of human cells it uses natural biological mechanisms to respond to blood sugar levels. Indeed, not only blood sugar is monitored and regulated by the pancreatic Islets of Langerhans, but numerous other activities in the blood, reflecting the body™s overall physiological state, are also relevant, and Pro-Islet will respond to the full array of inputs as well. Likewise, the response of Pro-Islet is not just that of releasing insulin, but also includes the full repertoire of beta cell functions that are lost in diabetes. As Pro-Islet will employ physiologically relevant detection, and response to blood chemistries on a continuous basis, as compared to pharmaceutical insulin, it may well represent a quantum advance in medical treatment for diabetes.
Product Development Towards the Clinic
ViaCyte intends to test Pro-Islet in diabetic patients in a Phase 1 clinical trial in the foreseeable future. In order to enable this clinical testing we are currently performing requisite pre-clinical studies to establish that the product is safe, effective, and reliable, prior to testing in humans. These pre-clinical studies will support an Investigational New Drug application that will be submitted to the FDA.
At this time, ViaCyte does not have any clinical trials in progress. When a clinical trial of Pro-Islet begins enrolling it will be posted on this website. In the meantime, we would refer those interested in clinical trials to the U.S. Government website, ClinicalTrials.gov.