I was saddened when I read articles in Nature reporting investigative results that patients in Texas have received unproven stem-cell treatments. As stated in a previous blog article, I believe that stem cells could eventually be a cure for a wide range of diseases and am therefore supportive of research into this area. However, just because they hold promise does not mean we should cut corners and proceed with less caution. In the article, a company called Celltex Therapeutics appears to be supplying doctors in Texas with adult stem cells which are then being used in unproven treatments for patients. While the company denies that it is involved, it will not elaborate on what their cells are used for.
The company has benefited from Texas governor Rick Perry’s support of stem cell usage and legislation to create “banks” which store stem cells harvested from patient’s abdominal fat. Roughly 100,000 mesenchymal stem cells are harvested and, over three weeks, are cultured until there are around 800 million cells. Patients then receive at least three injections containing 200 million cells.
There is some confusion as to whether this treatment needs to be approved by the FDA. Treatments using unprocessed tissue from the patient do not always require FDA approval, but these cells have been cultured. Does this classify them as being “minimally modified” and does that require FDA approval for their use?
Nature states from an unidentified source that cells kept outside the body overnight are considered more than minimally manipulated, and therefore would require FDA approval. My experience doing tissue culture has shown that cells can alter their morphology, protein expression, and can have genetic mutations within a short time frame. Therefore, these cells may not be exactly as they were when they were removed from the patient and would therefore require rigorous scientific testing for their effects when reintroduced to the patient.
Another issue with these “trials” is that patients are paying for them. The correct way to perform a clinical trial is with a placebo controlled trial, where the patients are unaware of their treatment, are willing volunteers, and do not pay. This is the only way to generate meaningful results which will affect therapies in the future. I cannot believe that anyone who knows the scientific method would jeopardize their research by performing it in any other way. If you are passionate about what you do, you would want it performed at the highest possible standard. Once that is done, and is shown to be reproducible by your peers, then real benefits could be seen by the patients in need. Not before.
The thing I find odd about this whole story is that the founder and long-time editor of the American Journal of Bioethics, Glenn McGee, was involved. He became the president of ethics and strategic initiatives at Celltex Therapeutics, but resigned three months later. On taking the position, he stated that Celltex Therapeutics would set up and run clinical trials and would be held to strict ethical standards. Obviously, if Celltex Therapeutics has been involved, as Nature suggests, then this isn’t the case.
Clearly, you can’t know all the details about a company before starting there, but this is a horrible case of potentially losing all the credibility you have spent a career building due to a misjudged decision. This is a reminder to learn as much as possible about potential employers before signing a contract as while it is a new job, it may not be a better one.
Fortune favours the bold, but please be bold enough to stand for well performed, ethically carried out research. It is only under these conditions that good science can be performed which will then benefit those that badly need treatments.
Disclaimer: The author is the Associate Director of the Stem Cell Training Grant at her institution which is funded by CIRM. These views are the authors own and in no way reflect the views of either her institute or CIRM.