A second person has received an injection of an embryonic stem cell-based therapy for spinal cord injury. The experimental procedure, a safety trial by the California company Geron
, took place in recent days in Chicago at Northwestern Memorial Hospital. The patient will rehab at the Rehabilitation Institute of Chicago.
Meanwhile, the one who got the first-ever FDA approved embryonic stem cell therapy last October has revealed himself to the media. Timothy Atchison, 21, was treated at Atlanta’s Shepherd Center, about 330 miles northeast of Chatom, Alabama where he was injured in a car wreck. Atchison’s accident occurred on the birthday of Christopher Reeve.
Ed Wirth, M.D., Ph.D., Medical Director, Regenerative Medicine at Geron, spoke at an April 30 stem cell meeting at Cedars-Sinai in LA. He said a six month evaluation of patient one showed no adverse effects, no unexpected changes in neurological status. An MRI showed there was no cavity at the lesion site, meaning that the injected cells (oligodendrocyte progenitor cells, or GRNOPC1) might be alive; there is no evidence of acute rejection.
According to Atchison, speaking to the Washington Post, he’s doing fine. Apparently he hasn’t grown a second head. Indeed, he says he is recovering sensation; he can feel it when you lift a bowling ball from his lap.
Why would Atchison come forward? This can’t be good for the folks doing the clinical trial, introducing a wildly extraneous variable in what was designed as a tight Phase I trial. What if Atchison had said he had headaches, or burning back pain? Recruitment would surely suffer; trialists could not possibly keep a lid on that news, not with the high profile this trial has. Now that Atchison says he’s feeling OK, will that also taint the pool of patients with undue expectation?
Two things of note from the media coverage of Atchison: The first is that he’s a Southern Baptist but cool with the irony of getting a treatment condemned on moral and religious grounds. Atchison says it’s all part of “God’s plan.”
“It’s not life. It’s not like they’re coming from an aborted fetus or anything like that. They were going to be thrown away,” he said. “Once they explained to me where the stem cells were coming from, once I learned that, I was okay with it.”
The second item reveals Atchison’s primary motive for breaking the seal on the trial: he said he’s been in contact with an agent to figure out how best tell his story. “We’re trying to figure out what’s in my best interest to talk about right now,” he said.
More Geron: On April 27 the company announced a loss of $25.9 million for the first quarter of 2011. That is an astonishing burn rate for a company that hasn’t got a product on the market yet. But just one week later the California Institute for Regenerative Medicine (CIRM, public funded from $6 billion Prop. 71 bond plan) granted Geron $25 million, specifically for the spinal cord injury trial.
Said Robert Klein, CIRM chairman who engineered the Prop. 71 vote, in large part by putting scientists and patient advocates on television: “We need to be prepared to stand by the heroic patients and the companies as they face these challenges and solve the problems that stand in the way of the recovery of patients from paralysis.”
More Klein: Speaking at the Cedars Sinai meeting, he said CIRM is part of a medical revolution but “the money runs out in 2017.” California voters will be asked to fund another $4 billion.