Geron gets nod for stem cell trial for acute SCI.
It apparently took 10 months to wade through the 21,000-page application, and perhaps a regime change at the top of the United States government, but the U.S. Food and Drug Administration finally gave the go-ahead to the nation’s first embryonic stem cell clinical trial.
The Geron Corp. has had data for several years showing that paralyzed rats got much better (they walked) after getting injected with a cell type generated from human embryonic stem cells. The company filed papers last March to move from lab animals to humans. The FDA, worried about safety, took its time with the process.
Timing? What timing? President Barack Obama said in his inaugural address on Tuesday that he’d “restore science to its rightful place,” George Bush is off to Texas and the very next day Geron gets a phone call from the FDA with the good news. But as Geron announced the decision today both the company and the FDA said the timing was purely coincidental. Here’s an FDA source: "The FDA looks to the science on these types of issues, and we approve [such applications] based on a showing of safety," said Karen Riley. "Political considerations have no role in this process."
Really? Science is now free from political pressure...now that is good news.
At any rate, this will be the first embryonic stem cell trial coming out of the regulated and scientifically vetted mainstream (which does not include stem cell soloists in India and the Dominican Republic). Geron will enroll 10 patients, that is, 10 unsuspecting people who will experience spinal cord trauma in the coming months. The goal of this Phase I trial is to establish that these cells, already fated to become a neural support cell, won’t grow out of control and won’t cause an immune response in the cord that exacerbates the trauma.
The work emerges from the lab of Hans Keirstead at the Reeve-Irvine Center in California. Read more
here.
This is terrific news for the Reeve Foundation. See the
ABC news coverage, featuring Board Chair Peter Kiernan, who describes the FDA action as a comet in our sky. Here’s Reeve Foundation CEO
Peter Wilderotter on the news and its connection to the legacy of Chris Reeve.
Interestingly, there was another big stem cell story earlier in the week. A British company called ReNeuron got approved by U.K. regulators to proceed with a stem cell treatment for people with ischemic stroke. The cells are not derived from embryos so there’s no political drama. Read more about that one
here.
Here’s the official Geron
press release.
Coverage, of course, is extensive.
Wall Street Journal.
And
New Scientist.
Mad
