Embryonic Stem Cells: A Small Step Forward?
Geron has started a clinical trial on a therapy that uses embryonic stem cells! Six years ago (or five, or four), this would surely have been not just front-page news but talk-show fodder and a major election issue. In 2010, not so much. The Washington Post carried an article about it, but the New York Times relied on a single paragraph from the AP. In the long run, however, the news may be significant -- if only because British and Korean researchers think so.
The experiment is actually a rather modest first step. It's a safety trial, using a population limited at present to one patient, though nine more may eventually be involved. To be eligible to participate, subjects must have suffered a partially paralyzing spinal cord injury less than two weeks before beginning the treatment. The first patient is in Atlanta, but others may be treated at different sites.
On the whole, neither supporters nor opponents of ESC research have gone overboard about this tentative beginning. Sir Ian Wilmut, for example, called it "exciting news" but added:
"[I]t is very important to appreciate that the objective of trials at this stage is to confirm first of all that no harm is done to patients, rather than to look for benefits."
There were exceptions to the tepid response: Commentator Michael Fumento branded the news "hype," quoted a neuroscientist calling it a "scam," noted that the 14-day limit is a timeframe sometimes associated with spontaneous recovery, and suggested that the experiment, "while it's unlikely to do much to advance health, could do a lot for Geron's financial prospects." Company shares did briefly spike on the news, but soon settled back to roughly where they've been all year.
On the other hand, British researcher Pete Coffey "has a spring in his step these days." His team in London is hoping to test an ESC-based therapy for macular degeneration, a common cause of blindness among the elderly. They are still a year or two away, but confident of getting permission now that Geron has cracked the door open.
Advanced Cell Technology is heading in the same direction, in partnership with a Korean team led by Professor Chung Hyung-min of the Stem Cell Institute of CHA University's College of Medicine, and of CHA Bio & Diostech. (The CHA Medical Center was the first Korean lab since the Hwang Woo-suk scandal to be given permission to try to create embryonic stem cells by cloning; they also work on iPS cells, and a California-based subsidiary at one point applied for a grant from CIRM.) As specified in their agreement, ACT has already applied for permission in the US to conduct an ESC-based experiment on 12 patients with Stargardt's macular dystrophy, which usually affects much younger people, and hope to broaden the therapy's application. Now the partners are also applying for permission to do clinical trials in Korea.
"If permission is granted," says the second paragraph of the report in JoongAng Daily, "Korea will become the second country after the United States to start clinical tests of the controversial therapy." This has obvious appeal to the Korean nationalism that Hwang notoriously played on, but it also could be seen as an attempt to nudge the FDA into approving the application.
Embryonic stem cell research has been associated with an extraordinary amount of hype, and thus far very little to show for it. That may explain the less than enthusiastic response to the news of this first, limited trial. But it's just possible that the boy who cried wolf may actually have seen one this time. Skepticism remains appropriate, but maybe, just maybe, therapies will eventually follow.
Update: The New York Times finally ran an article about the Geron trial on October 22nd. Also, Professor Coffey, the stem cell researcher who developed "a spring in his step" upon the launch of Geron's trial, was awarded a $4.9 million grant by CIRM, "aimed at helping to recruit Coffey to UC Santa Barbara" but he has not yet committed to do so (h/t California Stem Cell Report).
Previously on Biopolitical Times:
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