James, to expand on what you already know: Medical inventions ascend a ladder from concept through analysis in silico, prototype, laboratory testing, small-animal studies, and finally large-animal studies, on their way to human clinical trials. The Islet Sheet Project is following that path.

There was a time when researchers would experiment on themselves, and that road is still tempting. In the movie Contagion, the woman who invents what proves to be the effective antiviral tries it on herself. I sometimes muse about taking an Islet Sheet into international waters and having it implanted into me, skipping the FDA. Our society demands that we find a balance between health benefits and risk to patients. I personally favor great freedom but I also believe in obeying the law—and right now the law requires that a new therapy be studied to exhaustion in every alternative to human clinical trial. So be it.

Animal models are just that: models of disease. Some medical problems can be replicated in animals, like a broken bone. Others are unique to humans, like AIDS. Autoimmune (type 1) diabetes, in fact, is a disease that does not really exist in animals. But fortunately there is a pretty good model, the pancreatectomized large animal. (See Large-Animal Studies.) We believe that, properly done, this model will predict success in humans.

We expect to have the first large-animal results in 2012. So if all goes well, the first clinical trials could be in 2012—but there are always problems and delays, so I could be as long as five years. The important thing is that the Islet Sheet be found safe and effective in large-animal studies. From there to the clinic is a challenge I look forward to with pleasure.