Stem cell therapy set for first human trial

US Nod To Use Of Embryonic Cells For Treating Spinal Injuries Raises Hope For Accident Victims

Andrew Pollack

In a research milestone, the US federal government will allow the world's first test in people of a therapy derived from human embryonic stem cells.
    Federal drug regulators said that political considerations had no role in the decision. Nevertheless, the move coincided with the inauguration of President Barack Obama, who has pledged to remove some of the financing restrictions placed on the field by former president George Bush.
    The clearance of the clinical trial — of a treatment for spinal cord injury — is to be announced on Friday by Geron, the biotechnology company that first applied to the Food and Drug Administration to conduct the trial last March. The FDA had first said no, asking for more data.
    Thomas Okarma, Geron's chief executive, said on Thursday that he did not think that the Bush administration's objections to embryonic stem cell research played a role in the FDA's delaying approval. "We really have no evidence," Okarma said, "that there was any political overhang."
    Robert Klein, the chairman of California's $3 billion stem cell research program, called the approval of the first human trial of this sort "an extraordinary benchmark."
    Stem cells derived from adults and fetuses are already being used in some clinical trials, but they generally have less versatility than embryonic stem cells in terms of what tissue types they can form. The FDA approval comes a little more than 10 years after the first human embryonic stem cells were isolated at the University of Wisconsin, in work financed by Geron.
    Because the cells can turn into any type of cell in the body, the theory is they may one day be able to provide tissues to replace worn-out organs or nonfunctioning cells to treat diabetes, heart attacks and other diseases. The field is known as regenerative medicine.
    Geron's trial will involve 8 to 10 people with severe spinal cord injuries. The cells will be injected into the spinal cord at the injury site 7 to 14 days after the injury occurs, because there is evidence the therapy will not work for much older injuries.
    The study is a so-called Phase I trial, aimed mainly at testing the safety of the therapy. There would still be years of testing and many hurdles to overcome before the treatment would become routinely available to patients.
    Geron, which is based in Menlo Park, California, said that it had identified up to seven medical centers for the trial but that those sites must first get permission from their own internal review boards to participate.
    Even as some researchers hailed the onset of clinical trials, others expressed trepidation that if the therapy proves unsafe — or even if it is safe but does not work — it could cause a backlash that would set the field back for years. "It would be a disaster, a nightmare, if we ran into these kinds of problems in this very first trial," said John Kessler, the chairman of neurology and director of the stem cell institute at Northwestern University. NYT NEWS SERVICE