Sernova recruits first subjects for its Cell PouchTM diabetes clinical trial

People living with type 1 diabetes (T1D) are dependent on insulin therapy to keep their blood sugar levels from rising too high, which can lead to long-term complications, such as kidney and heart failure. As this can be an imperfect treatment, researchers have been experimenting with islet transplantation – the transfer of insulin-producing cells from a donor’s pancreas to a person with type 1 diabetes (T1D) – as a promising therapy that would eliminate the need for insulin injections.

Since 2016, JDRF and Sernova Corp., a clinical-stage regenerative medicine company, have been collaborating on innovative technology to treat hypoglycaemia (low sugar) unawareness in patients with severe T1D. An alternative to drugs, cell pouch technologies involve implantable medical devices that form a highly vascularized environment in the body for the housing, function and long-term survival of therapeutic cells, which release proteins or hormones to treat chronic diseases like T1D.

Recently, Sernova announced the enrollment of the first three of seven subjects in its US-based Phase I/II trial of Sernova’s Cell Pouch™ for clinical islet transplantation. Study subjects will receive Sernova’s Cell Pouches, including a small sentinel device implanted under the skin. Following a defined period to allow for the development of vascularized tissue chambers, immunosuppression will be administered along with a dose of purified islets.

The primary goal of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch among participants with hypoglycemia unawareness. The secondary goal is to assess the device’s efficacy in reducing severe hypoglycemic events and ensuring the survival of islets following transplant.

Sernova is expecting to report preliminary safety data from this landmark clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.

Through advances in encapsulated cell therapies, researchers hope to reduce the burden of T1D by addressing many of the shortcomings and challenges of current insulin therapy, while significantly increasing the quality of life of people with the disease.

For more information on enrollment and recruitment details, please visit or contact (773) 702-2504.

For more informative articles on health and type 1 diabetes, visit our JDRF Blog

#AccessForAll: We’re demanding affordable and accessible coverage for everyone living with type 1 diabetes


By Patrick Tohill, Government Relations Director at JDRF Canada

JDRF is excited to be launching our new Access for All campaign this week to urge provincial and territorial governments, insurers and employers to help make life-changing technologies such as continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) affordable and accessible for Canadians with type 1 diabetes.

When it comes to managing T1D, the two most important aspects of diabetes care are the administration of insulin (by pump or multiple daily injections) and maintaining a constant and accurate measurement of blood sugar. Advanced glucose monitoring technologies, such as CGM and FGM, significantly improve the ability of those with type 1 to maintain a constant and accurate measurement of blood sugar, regardless of whether insulin is delivered via an insulin pump or multiple daily injections.

They take much of the guesswork out of blood sugar management, by providing users a more complete picture as to what’s happening with their blood sugar over the course of the day. With traditional “finger-stick” blood testing, many daily highs and lows were missed. The ability to track and understand how one’s blood sugar may “go low” at a certain point each day or “go high” at another helps people with T1D adjust their diet and routine so they can avoid highs and lows that might send them to a clinic, a hospital emergency room…or worse.

More data leads to better decision making and evidence shows that these devices can help lower overall blood glucose (HbA1C) as well as help users spend more time in target range. So, in addition to keeping people out of the hospital, advanced glucose monitoring devices may be expected to significantly reduce the probability of long-term complications such heart attack, stroke and nerve damage, long-term complications that are extremely costly to taxpayers and absolutely devastating for the individual and those who love them.

At present, these devices cost thousands of dollars annually placing them out of reach for the average Canadian. And while most employee benefit plans now cover FGM and many also now cover CGM, this leaves the bulk of the population to either go out-of-pocket to cover the expense themselves or do without.

Our #AccessForAll campaign aims to increase public (provincial government) and private (employer insurance) coverage for these advanced glucose monitoring technologies, helping Canadians with T1D to achieve tighter control over their blood glucose and making them affordable for all Canadians with T1D.

You can support JDRF’s Access For All campaign by sending a meeting request to your provincial representative today. Explain how advanced glucose monitoring devices are life-changing for those with T1D and why it’s important provincial governments make them affordable and help reduce costs for their constituents.

Take action today by meeting, calling or writing to your provincial representative to urge them to support reimbursement for these technologies. If you or someone you love lives with T1D, feel free to add some personal details. Your story will help them understand just how valuable these technologies can be in helping to manage T1D.

This is just the first step in the fight to change the day-to-day lives of Canadians with T1D.

If enough of us speak up, we can make a greater impact and our demand for accessible and affordable diabetes care will be heard. Lend your voice to this campaign and help us get #AccessForAll.

Drug approved for treatment of psoriasis and Crohn’s disease may protect beta cell transplants

Beta cell replacement therapy is one of several treatment options used to improve the health and quality of life of people with type 1 diabetes (T1D).

Currently, JDRF-funded researcher, Dr. Jan Dutz, and his team at the University of British Columbia are investigating whether the administration of an antibody called ustekinumab among adults and children newly diagnosed with T1D can protect insulin-producing beta cells.

In T1D, the immune system’s T-regulatory cells (T-reg) attack and destroy beta cells leaving individuals with a lifelong dependence on either injected or pumped insulin. Blood glucose control is often imperfect, sometimes leading to an increased risk of complications stemming from chronic hyperglycemia (high blood sugar), which includes a shortened life span.

Studies have shown that ustekinumab, a highly effective drug approved for safe use in psoriasis and in Crohn’s disease, is successful in preventing T-reg cells from harming beta cells, thereby reducing the demand for insulin and preserving insulin secretion.

In Phase 1 of the Ustekinumab Trial funded by JDRF through the Canadian Clinical Trials Network, Dr. Dutz demonstrated that ustekinumab inhibits inflammation and can be safely administered to young adults with new onset T1D. As well, the drug was able to block the activation of T-reg cells in animal models and in humans with T1D, thus preserving beta cell function and insulin secretion.

In Phase 2 of the Trial, Dr. Dutz will be testing ustekinumab’s ability to inhibit the development of the disease in adults with recent onset T1D. The trial will see 60 young, newly diagnosed (within 100 days) adults randomly assigned to receive ustekinumab or a placebo for one year with their pancreas’ function monitored during that period. Knowing this drug will reduce the inflammatory proteins that cause beta cell destruction, Dr. Dutz believes it can also stop the advancement of diabetes by protecting the remaining insulin-producing beta cells in the pancreas, and allowing them to secrete insulin and regenerate.

Ustekinumab offers a potential new therapy that can prevent or slow the progression of T1D. As a result, newly diagnosed individuals will be able to decrease their dependence on insulin, better control their blood sugar and lower their risk of complications.

For more informative articles on health and type 1 diabetes, visit our JDRF Blog