Good morning friends. The US federal government will allow the world’s first test in people of a therapy derived from human embryonic stem cells. It has been said that political considerations had no role.
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.
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. 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, 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.
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.
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.”
Ref: The Times of India
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