Sernova to enroll more for cell pouch system trial

Sernova’s Cell Pouch System is an implantable and scalable medical device that forms a natural environment in the body for the long-term survival and function of therapeutic cells. These cells release necessary proteins or factors missing from the body to treat chronic diseases, including insulin-dependent diabetes.

According to www.drugdeliverybusiness.com, the University of Chicago Institutional Review Board (IRB) has now approved a further clinical trial to enables the testing of up to seven patients, who would receive Sernova’s optimized 10-channel Cell Pouch with a 50% greater islet capacity compared to that used in trials to date.

Sernova now plans to begin enrollment for this second trial  and expects results to help guide the design of its pivotal study to support its anticipated biologics license application (BLA) to the FDA.

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