Landmark stem cell trial begins

A US company has announced that it has begun a clinical trial with embryonic stem cells in the hope of curing spinal cord injuries. Ho hum.

Even stem cell experts are worried that embryonic stem cells might cause tumours.

The announcement by the Geron Corporation that it will begin the first human trial using stem cells derived from human embryos has been greeted with applause from across the research community. Having invested $170m developing its treatment for spinal cord injury, the biotechnology giant becomes the world’s first recipient of a license to begin Phase 1 clinical trials with human patients using embryonic stem cells (ESCs), highly malleable cells derived from early stage embryos.

Despite the excited speculations made by some commentators however, does Geron’s announcement really signify any major breakthrough?

The license, granted by the US Food and Drug Administration, follows results indicating an improvement in the conditions of rats when treated shortly after suffering spinal trauma. Yet Geron has carried out no testing of primates or in animals with a longer spinal cord than rodents, instead proceeding directly to first-in-human trials using ESCs.

Concerned perhaps at this irregular jump in the research process, even leading proponents for ESC research have given a lukewarm reaction to Geron’s announcement. As Professor Ian Wilmut, creator of the first cloned mammal, Dolly the Sheep, has admitted: “It is very important to appreciate that the objective of trials at this stage is to confirm first of all that no harm is done to patients, rather than to look for benefits”.

These comments represent more than just a management of expectations for two reasons. First, experiments using embryonic stem cells have yielded little benefit in practical terms since they were first identified in 1981, having led to no cures or insights despite significant funding worldwide. Second, perhaps due to their early undifferentiated status, ESCs tend to cause tumours. The main purpose of this trial is not to cure the patient, but to see whether Geron’s scientists have been able to tame the wildly proliferating ESCs. As Wilmut’s note of caution suggests, Geron should be concerned with protecting both the human subjects of this research – and their own commercial liability.

Given such concerns, to many patient groups – particularly those with spinal injuries whom this announcement might be seen as holding out the greatest promise – the overwhelming feeling may be: “So what?” ESCs hold no imminent hope of success, and alternative treatments are already being used to treat spinal patients.

For example, treatments have been carried out using adult stem cells – that is, early undifferentiated cells found in the human body – since as early as 2001, when Dr. Carlos Lima at the Egas Moniz hospital in Portugal used cells harvested from patients’ nasal cavities to treat damaged and even severed spinal cords. In comparison to Dr. Lima’s success, it has taken proponents of ESCs a further nine years just to arrive at the starting gates.

Incidentally, the success of adult stem cell research does not begin and end with treatments of spinal patients, having been used to treat no fewer than 73 conditions. Of these, some of the most exciting results arising from adult stem cells include cures for blindness and sickle cell disease, as well as being used to overcome tissue rejection issues in the world’s first windpipe transplant in a child.

The most interesting aspect of this announcement was its timing. It comes just weeks before a vital deadline. The US Court of Appeal, currently considering whether federal money may be used to fund experiments using ESCs, has set a cut-off date of November 4 for both sides to submit all relevant documents ahead of its ruling. In the light of the Geron announcement, pro-ESC enthusiasts may be celebrating both a PR coup and a potentially significant addition to their side’s submission to the Court – as well as providing a pre-mid term election reminder to American voters of an issue which has previously worked in the Democrats’ favour.

In terms of concrete actual treatments however, ESC research is likely to take several years to arrive at a therapy which has already been pioneered by adult stem cells – therapies which themselves continue to be developed further by researchers, and contain none of the ethical objections raised toward ESCs.

For this reason, Geron’s big story is that there IS no story. There certainly is no imminent reason for excitement among patients currently suffering from spinal injuries (still less those with other debilitating conditions). While this announcement has been noteworthy for headline-hunters, patient advocate groups may eventually be left wondering what all the fuss was about.

Patrick Cusworth is a public affairs consultant in the UK, specialising in the science, research and technology sector.  He holds a Masters degree in Medical Law and Ethics and has a particular interest in stem cell research.

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