Embryonic stem cells can develop into any cell of the body, and scientists have long hoped to harness them for creating replacement tissues to treat a variety of diseases. But research has been controversial because embryos must be destroyed to obtain them.
(Related: "Stem Cells Discovered in Amniotic Fluid, Scientists Announce" [January 8, 2007].)
President Barack Obama has promised to relax the Bush administration's restrictions on federal financing for such research. But Obama's ascent to the White House had nothing to do with the U.S. Food and Drug Administration's granting permission for the new study, Okarma said in a telephone interview Thursday.
In fact, the company says, the project involves stem cells that were eligible for federal funding under Bush, although no federal money was used to develop the experimental treatment or to pay for the human study.
Other human cells, called adult stem cells, have been tested before in people to treat heart problems, for example.
In the Geron study, the injections will be made in the spine at the site of damage. The work will be done in four to seven medical centers around the country, Okarma said.
Animal studies suggest that once injected, the cells will mature and repair what is essentially a lack of insulation around damaged nerves, and also pump out substances that nerves need to function and grow.
Apart from assessing safety, investigators will hope to see some signs of improvement in the patient, Okarma said. The idea is "not to make somebody ... get up and dance the next day," he said, but rather to provide some level of ability that can be improved by physical therapy.
Each patient will receive a low dose of anti-rejection drugs for about two months, because after that time the medications shouldn't be needed, Okarma said. The study will follow each patient for at least a year.
Future Medicine
Okarma said he can't estimate how much such a therapy would cost if it proves effective, but that "this is not going to be a $500,000 price tag. It will be remarkably affordable ... in the context of the value it provides."
Evan Snyder, a stem cell researcher at the Burnham Institute for Medical Research in La Jolla, California, said scientists in the field will focus chiefly on the study's results about safety.
"The one hope that everybody has is that nothing bad happens," he said.
Geron Corp. has spent at least $100 million on human embryonic stem cell research. Founded in 1992, it does not have any therapies on the market.
However, the company is considered the world's leading embryonic stem cell developer thanks to its claims on several key stem cell technologies. Geron helped finance researchers at the University of Wisconsin who first isolated human embryonic stem cells in 1998. The company has retained exclusive rights on several of those cell types.
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