Wednesday, January 28, 2009

Stem Cell Study Approved by FDA

The first ever human trials for a medication based on Human Stem Cells has been approved by the FDA. Popular science covers this result this week.  This is an exciting first step for stem cell medicine as it pertains to humans. All research so far has been done with animals and very narrow parameters, so this is a "first shot across the bow" as said by Wise Young, director of the W M Keck Center for Collaborative Neuroscience at Rutgers University.

What does this mean for medications coming to market? Well it would be years (>5) before this drug will make it to market (if it succeeds) and also it could FAIL! Even if this trial is successful the technique is only expected to work for recent injuries in limited cases. I think this is like the first Chemotherapy trial we had years ago where people started thinking "we might have cancer beat" and with time we realized how complicated cancer and it's mechanisms are. Clearly though this means we're stepping along the inevitable progression most technologies see. This is as usual a bell curve: 

This is a nice bell curve borrowed from Wikipedia. We see this happen with a LOT of technologies. People in the industry see the promise of something and coalesce around it, but it takes a LONG time to get those things out there in industry. Still people over commit early, and end up wasting a lot of work because they adopted too early. This is why I often don't like to pay extra to be a "beta tester" for early technology by buying early.

My guess is we'll see more trials of stem cell based treatments and things like gene therapy as we merge into the biotechnology age that is emerging as we speak. It's exciting, but still VERY early!

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