Sernova Corp has announced that the first two patients in the second cohort of its active U.S. Phase 1/2 clinical trial for the treatment of Type 1 diabetes received their first islet transplant into the higher capacity 10-channel Cell Pouch™.
The Sernova Cell Pouch System is a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases.
The patients in the trial will be monitored for safety and efficacy for three months, after which a second dose of islets is anticipated to be transplanted in accordance with the protocol. Additionally, a third enrolled patient has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks.
“I am excited to apply the learnings from the first patient cohort, including implementation of the higher capacity Cell Pouch, which enables us to optimize the dose and concentration of islets to achieve our clinical objectives with these patients,” said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and Director of the Pancreatic Islet Transplant Program at the University of Chicago.
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