I don't remember seeing some of this info previously. Surmodics never brings up or is asked about Novocell during quarterly meetings. Have they become a non-factor (any thoughts). Looks like 2010 may be interesting.
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. Clinical trials are expected to begin in 2010 using these cells, in combination with the cell encapsulation technology for the treatment of diabetes.
The 11/26/2007 Company History and Profile is an interesting read
It could come to pass that stem cell therapies leapfrog over encapsulated islets before the encapsulation technique ever develops much traction (given the difficulties of obtaining islet cells to encapsulate). These mice were only a model though - if they don't possess islet cell antibodies (as a Type I diabetic presumably would) they may have been spared the islet destruction that would have occured in a human without some form of immunosupresion or encapsulation.
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