Tirst two partially implanted patients are showing early evidence of encapsulated islet function. Novocell presented data from its phase I/II proof-of-principle clinical trial for encapsulated primary human islet allografts in a late-breaking poster presentation at the American Diabetes Association’s 66th Scientific Session.
The poster entitled "Encapsulated Human Islet Allografts — Phase I/II Clinical Trial" described safety and efficacy results following subcutaneous implants of encapsulated human islet allografts into patients with Type I diabetes of long standing duration. The first two partially implanted patients are showing early evidence of encapsulated islet function. The recipients are not showing evidence of encapsulated islet destruction by autoimmune reactions or allograft rejection to date. The patients only received transient low dose cyclosporine (50-100 ng/ml 12hr trough) and do not receive cyclosporine long term or any other form of immunosuppression.
"Patients are free of any safety concerns or adverse events to date," commented
David Scharp, M.D., Chief Medical Officer. "We hope to see additional efficacy as these recipients receive increasing doses of encapsulated islets."
Novocell believes its proof of principle study is important to demonstrate the safety and efficacy of the encapsulation technology that can be used with the unlimited source of insulin-producing cells developed from stem cells to treat patients with diabetes.
These findings were presented at the 66th Annual Scientific Sessions of the American Diabetes Association (ADA) in Washington, D.C.
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