Well after years of saying it was coming, finally Geron got permission to attempt a human trial of its ESC-derived drug for acute spinal cord injury. (This is not a direct infusion of stem cells, but of a type of adult neural stem cell created by differentiating the ES cells.) This is not an efficacy trial, but a safety trial, and will only target patients with new injuries since it did not work in rats with older paralysis. From the story:
Although the FDA says it does not make decisions based on politics, the company made the decision public just days after Obama was sworn into office. Stem cells are the body’s master cells, giving rise to all the tissues, organs and blood. Embryonic stem cells are considered the most powerful kinds of stem cells, as they have the potential to give rise to any type of tissue.
But they are difficult to make, requiring the use of an embryo or cloning technology. Geron and some other companies have been pursuing the goal without the use of federal funds.
The story doesn’t mention it, of course, but adult stem cell therapies have been in human trials for several years for paralysis caused by spinal cord injury—and the first peer reviewed study showing a restoration of feeling never received the coverage in the media that Geron has received repeatedly for years about this prospective trial—apparently because our news censors believed they were the wrong kind of stem cells.
And this part of the story make my Nader genes itch and illustrates vividly what has gone so wrong in this field—it is utterly market/stock obsessed:
Shares of Geron rose nearly 30 percent to $6.75 in premarket electronic trading on Nasdaq.
One can’t and shouldn’t wish this trial bad luck—people’s health is involved. But one can hope that if this drug proves safe in humans—still a big if—and if it works—perhaps a bigger if—its benefits are soon swamped by methods of treating spinal cord injury that are ethical and don’t require the destroying of nascent humans to help those who are not in the developing stage.
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