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  • drrobhale drrobhale Jun 25, 2005 6:26 PM Flag

    What Happened ?

    ASTM has had previous clinical trials, why were the trials not completed?

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    • CB-I is (was) for use with umbilical cord blood. The market in this area is still relatively small and the testing time consuming. For example the phase 1 study done at Duke university with CB-I spent one year transfusing patients with the output of CB-I, and another 4 plus years of follow up. I believe ASTM has stated that the follow up for bone repair will be 18 months.

      SC-I/II, and Dendricell were about treating cancer. This is a field that not only kills people, it kills companies trying to find cancer cures. To test a cancer cure you spend a lot of time and money, and when the study is complete, you perform an arcane statistical analysis. If you're lucky your analysis tells you that that the treatment helps a little bit. You then take your analysis to the FDA and try to convince them that the statistical analysis is valid.

      With bone repair, they seem to have a situation where you don't need to have a team of statistician debate whether or not the treatment was a success. Or at least this was the case in the data that was recently released. In addition the studies are cheap, relatively quick to perform, and the potential market is very large.