Primum non nocere - first do no harm
Early Tuesday morning (12 October) Australian’s awoke to some significant news out of the United States. Biotechnology company Geron had announced that it had treated its first patient will cells made from human embryonic stem cells (hESC).
The announcement marks the beginning of Geron’s phase I clinical trial that is looking to treat up to 10 patients with acute spinal cord injury. The purpose of the study is to assess the safety of Geron’s stem cell based product with participants being closely monitored after treatment to ensure there are no detrimental effects. Only if no harm is reported will the trial proceed and involve larger numbers of patients to really see if the treatment will actually restore some function. It may be several years before the outcomes are fully known.
Since the discovery of hESCs in 1998 so much has been written, debated and expected from these cells. It sometimes seems hard to comprehend that the first clinical trial is only now just underway. Twelve years is relatively short in the field of medical research, but for an individual or their family who are hoping that stem cells may be the answer to a currently incurably disease and have been monitoring the fields’ every breakthrough, twist and turn, it may have seemed excruciatingly long. Also confusing the issue are the growing number of companies and clinics that are advertising stem cell therapies to treat a vast range of conditions now with little or no regulatory oversight or in deed scientific or medical evidence to justify their claims. This is in stark contrast to the lengths that Geron has undertaken to obtain appropriate regulatory approval prior to starting to test the cells in patients.
Last week at the World Stem Cell Summit in Detroit, the CEO of Geron outlined the significant and appropriate hurdles the company had to clear with the US regulator the Food and Drug Administration (FDA). As this is the first ever trial involving hESC derived cells the FDA were understandably cautious in the interest of patient safety with the final submission including no less than a hefty 28,000 pages of details of Geron’s experiments in animals, their processes and follow up procedures.
For those watching the field, the regulators demands may seem unnecessarily onerous and bureaucratic, but this is the best process we have to test if the treatment is safe and importantly
does no harm. Hats off to Geron for making it here first, they are paving the way for future stem cell therapies.
For more information on clinical trials, stem cells and how to navigate the maze of stem cell therapies the ASCC has developed a
Patient Handbook which can be downloaded for free from our website. In addition the International Society for Stem Cell Research has a website dedicated to providing information on stem cell therapies, visit
www.closerlookatstemcells.org.
More information on the Geron’s clinical trial can be found on Geron’s website or on the US based
www.clinicaltrials.gov (search on GRNOPC1).