Cell Encapsulation

Novocell utilizes a biocompatible polyethylene glycol (PEG) conformal coating that enables implanted cells to survive and function. This proprietary cell encapsulation technology eliminates the need for continuous immunosuppressant drugs and has been formulated to allow the encapsulated islet cells to release insulin in response to the recipient’s blood glucose concentration.

Employing this cell encapsulation technology, Novocell has successfully controlled blood glucose in trials involving more than 30 diabetic non-human primates. In these trials, allograft (same species) islets were implanted into diabetic recipients with only 30 days of low dose cyclosporine, an immunosuppressant. After cyclosporine was discontinued at 30 days, implanted cells continued to function for up to 20 months. All implants were simply injected under the skin of the recipients.

Based on these results, Novocell received Food and Drug Administration (FDA) approval for a Phase I/II clinical trial, which began in December 2005. The encapsulation has since shown preliminary evidence of efficacy and safety in a Phase I/II proof of principle clinical trial in patients with type 1 diabetes.