In October 2010, the first human clinical trials began for a drug based on human embryonic stem cell research.
This research involves a therapy developed by California biotechnology company Geron for treating spinal cord injuries. The extremely delicate spinal cord can easily suffer permanent damage in an injury, leading to paralysis of (depending on where the injury occurs) lower and even upper limbs. Current treatment options are limited, although in some cases very rapid treatment can restore some function which would otherwise be lost.
Geron, however, has spent years and hundreds of millions of dollars developing an alternative treatment based on embryonic stem cell research. Embryonic stem cells are capable of shaping themselves into any other type of cell found in the human body, and therefore researchers have long believed their versatility can be used in a wide range of cutting-edge medical therapies. In Geron’s case, the stem cells have been altered so that they become nerve cells, and will then be sent to the damaged spinal cord and possibly help restore nerve function there. In the first trial, going on now, a miraculous cure is not really the objective: the first step is simply to determine whether the drug is safe in humans.
The Geron trial will involve patients who have suffered a spinal cord injury in the last two weeks prior to beginning treatment. The first of the recipients is at the Shepherd Center in Atlanta, and his or her personal identity is not going to be disclosed publicly by the researchers. Six other hospitals are also listed as part of the study, and any (or all) of them could recruit patients in the near future. If the first trial works, then there will be further trials conducted to determine the drug’s effectiveness and optimum dosages. However, even if Geron’s gamble on this particular therapy pays off, it is important to realize that it is still years away from common use in America or any other country.
This clinical trial has been the subject of considerable debate, but it has also been a long time coming. The first news that the Food and Drug Administration (FDA) was poised to approve the study, in up to 10 patients, came back in 2009 (according to the Wall Street Journal). The FDA’s approval was put on hold for over a year, however, after trials in mice turned up some anomalous readings. Geron conducted new mouse studies and has apparently cleared up the matter to the FDA’s satisfaction.
