Jan 2015

Diabetes trial cleared by Health Canada

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Recently, we blogged about the first U.S. patient successfully implanted with a device to treat type 1 diabetes.

Good news is that the VC-01 device will soon be tested on Canadian patients. After the U.S. Food and Drug Administration approval of the testing in August 2014, Health Canada has now cleared the beginning of the Phase 1/2 clinical trial of the VC-01 in Canada.

The device, developed by the American company ViaCyte, is about about half the size of a credit card and can be implanted under the skin from where its progenitor cells secrete insulin whenever blood sugar levels get too high, restoring glycemic harmony. It is being tested at the University of California, San Diego Health System for its safety, tolerability and efficacy in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function.

“The first cohort of patients in this two-cohort dose escalation study of the VC-01 product candidate is currently being assessed at a single site in the United States. Health Canada’s approval represents further validation of the trial and allows us to expand internationally to one or more sites in Canada.” Dr. Paul Laikind, President and CEO of ViaCyte said in the press release.

The location and enrollment start date of the Canadian trial site are yet to be released, but there is already a strong connection between Canada and ViaCyte. Edmonton’s Dr. James Shapiro, Director of the Clinical Islet Transplant Program at the University of Alberta, is a scientific advisor with ViaCyte. In 1990s, Dr. Shapiro co-developed the Edmonton Protocol, a procedure for implementing pancreatic islets for the treatment of type 1 diabetes.

Although the VC-01 clinical trial is in its early stages and it is unsure whether it will become a safe and efficient treatment option for diabetes, it represents an important step towards a cure for the disease.

Learn here how up to 10 treatments for chronic diseases will be developed over the next 10 years thanks to the Canadian Stem Cell Strategy & Action Plan.

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