Clinical Trials

Novocell received Food and Drug Administration (FDA) approval for a Phase I/II clinical trial to assess the safety and efficacy of implanting human pancreatic islets encapsulated with polyethylene glycol (PEG) into a subcutaneous site in patients with Type 1 diabetes, without the need for long term immunosuppression. The islets are protected from immune destruction after implantation with the PEG coating. The islet cells were isolated from pancreas derived from consented human donors.The trial began in December 2005. Recruitment for this study is closed and the patients continue to be monitored. The encapsulation has shown preliminary evidence of efficacy and safety in patients with Type 1 diabetes.

The company is currently developing insulin-producing cells from hESCs and expects to produce large quantities of safe and functional islet cells to treat insulin-dependent Type 1 and Type 2 diabetics.