Hans Keirstead, UC Irvine

Thrilled to be here, my first visit to wisconsin

Hans has up his slide of a human egg sitting inside a fallopian tube with a speck of blue heading towards it . . . we don't have this much fun making stem cells, we do it by a different means

we've just started a scnt program after 2 years of working with the irb to get a source of eggs

the point is that we have a variety of sources for stem cells; research on all of them is very important

what ive been trying to do in my lab is generate high-purity human cell populations

we're going to need them

we could:
get cellular replacement strategies
do drug screening
do predictive toxicology -- which means use them to do tests in vitro to lower costs and not have to test in hman beings

we've got a couple of principles
we make fda compliant cells, we have 3 people making sure our cells are made with gmp
we aim for commercial viability because without the m we can't get to the clinic
we sa started with hesc-derived lo oligodendrocytes in high purity
my lab has done a great deal of work validating demylenation as a target for spinal cord injuries

we owe a debt to geron for pushing this through to the clinic . . . probably in 09 . . .

we then moved on to making high purity human motor neurons, certified as 99.6% pure . . . we're making 1-10 billion cells per week.

our animal models (unpublished data) show tremendous recovery

california stem cell is producing these plates that allow scientists to use these cells -- 5 days to use them --

this program is marching along toward the clinic.
both studies have a great deal of efficacy data generated with millions and millions of dollars on safety studies

the first study for the motor neurons will be a disease that attacks infants and kills them . . . characterized by highly specific motor neuron loss.

challenges?

repetition of experimental findings--takes a long time
safety studies--it took us 8 months and 1.5 million bucks to get done
large animal studies--must develop
manufacture and qualify the cells before you get to the FDA
medium in which the cells are made
clinical synopsis must be developed
outcome measures must be developed
financing the whole shebang.

one of the greatest challenges boils down to the isolation of academics
the change from basic research and discovery requires that we scientists engage with government,