Tuesday, October 21, 2014

Health Canada okays Sernova trial of Cell Pouch

May 2, 2012 by · Leave a Comment 

Sernova (TSX-V: SVA) has received Health Canada approval to conduct a human clinical trial assessing the safety and efficacy of its Cell Pouch with transplanted insulin-producing islets in patients with insulin-dependent diabetes.

The Phase 1/2 study, with up to 20 patients, will be conducted in collaboration with Dr. James Shapiro at the University of Alberta Health Science Centre in Edmonton.

Patients will be implanted with the Cell Pouch approximately two-to-12 weeks prior to transplantation of donor human islets. To prevent islet graft rejection, patients will be treated with the standard immunosuppressive regimen.

The primary safety endpoint will be assessed just prior to islet transplantation and one month thereafter. The secondary endpoint is to determine the proportion of subjects implanted with the Cell Pouch and transplanted with islets that achieve and maintain insulin independence as measured three months post-final islet transplantation. The study will also provide preliminary data on the efficacy of the Cell Pouch to maintain adequate immunological protection.

“The initiation of this study marks a significant milestone for Sernova, and is the result of years of hard work and dedication from our company’s staff and collaborators,” CEO Dr. Philip Toleikis said in a statement.

“We have developed the subcutaneous Cell Pouch for Sernova’s first clinical application, insulin-dependent diabetes, as an alternative site for islet transplantation that may allow for safer, more efficient engraftment of islets and potential improved long-term insulin independence using a marginal islet mass,” he added.

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