Can you discuss any political, ethical or regulatory obstacles associated with the Islet Sheet and encapsulation technology?
Maybe I’m Pollyanna but at this point I don’t see many political, ethical or regulatory obstacles. At least for our first clinical trials which will use human islets, like the Edmonton protocol. These islets are regulated by the FDA already, so we need only show that the sheet itself is safe. Certainly the situation at UC Irvine could not be better — we are getting enthusiastic support from the top to the bottom of the Irvine branch of the University of California. Longer term we will need a massive source of islets. The people of California are investing billions of dollars in islets from stem cells and that may work out. Mid term we look to pig islets, and fortunately there is a supplier of clinical-quality islets in New Zealand. The political, ethical and regulatory obstacles that Living Cell Technologies (New Zealand) faced there took years to resolve but they are now conducting human studies with encapsulated pig islets. We need only replace their current microcapsule system with
