The Geron Stem Cell Trials

         A 2010 clinical trial funded by Geron Corporation and conducted at several U.S. sites (with Atlanta’s Shepard Center the most prominent location) involved the use of human embryonic stem cell based therapy on patients suffering from spinal cord injuries (SCI). Dr. Hans Keirstead and Dr. Gabriel Nistor worked closely to see if stem cells could possibly be used in regenerative care - not necessarily to cure the patients, but to build a foundation for a cure. The trial was the first to use human embryonic stem cells to treat any such injuries. Thus, the overall goal of the study was essentially uncovering untouched territory and breaking through. While the SCI trial was active, 10 patients were enrolled. However, only 5 patients were treated with the stem cell based therapy, leaving another 5 without the treatment they advocated for when the trial was abruptly discontinued.

         Since those suffering from SCI were already in a vulnerable position, they were far more likely to agree to the trial and enter it with hope, completely unaware of the company’s ability to cease operation due to underlying business concerns. The trial required that “all patients will have to have sustained their injuries within 1 to 2 weeks of treatment.” In other words, patients were required to read, understand, and agree to the conditions of the trial only weeks after suffering a life-altering injury. Because the only eligible individuals were very vulnerable, a variety of ethical issues emerged.

         Firstly, due to the quick-natured oncoming of the treatment, patients were prone to experience therapeutic misconception; patients were likely to “conflate the early-phase research with a cure due to the limited amount of time between initial injury and treatment.” As stated by patient Katie Sharify in an interview following the trial, she had no idea what stem cells were, let alone what a Phase I trial was before her injury. The details of the trial that were made aware to her immediately following her injury were slightly misinforming; she was led to believe that she could be cured of her SCI. This, of course, was not the attempt of the trials, but was nonetheless a dangerous misconception.

         Secondly, the dramatic depictions of SCI research in animals led expectations of this trial to be abnormally high, leading to false hope. Next, the trial was discontinued after only one year. The company claimed that the funds and efforts would be directed towards cancer research instead. Conveniently for individuals in positions of authority, informed consent forms typically do not mention the potential that business considerations may lead to the premature discontinuation of trials. Once the potential benefits of a trial, such as Geron’s SCI trial, disappear, “so too do the grounds on which human subjects have given their consent.” This leads to a lack of trust between patients and researchers. After all, the discontinuation of this clinical trial justified the assumption that the “corporate bottom line” was the company’s true concern rather than advancing towards the cure for SCI.

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Resources

Daily Mail Reporter. "Geron Halts World's First Trial Using Human Embryonic Stem Cells." Daily Mail, 15 Nov. 2011, www.dailymail.co.uk/health/article-2061933/Geron-halts-worlds-trial-using-human-embryonic-stem-cells.html.

DeWitt, Natalie. "Fifth Geron Stem Cell Trial Participant Discusses Her Experience." The Stem Cellar, California Institute for Regenerative Medicine, 16 Nov. 2012, blog.cirm.ca.gov/2012/11/16/fifth-geron-stem-cell-trial-participant-discusses-her-experience/

Dobmeyer, Rita, and Flavio De Rosa. “From Laboratory Bench to Registration and Marketing Approval: Clinical Development for the Biomaterial Developer.” Biomaterials for Stem Cell Therapy, CRC Press, 2013, pp. 594-618.

“Geron Exits Stem Cells.” Stem Cells Accelerated, 1 May 2012, https://stemcellsaccelerated.wordpress.com/2012/05/01/geron-exits-stem-cells/. 

"Geron human embryonic stem cell trial starts." Biotechnology Law Report, vol. 30, no. 1, Feb. 2011, p. 74. Gale Academic OneFile, https://doi.org.libweb.lib.utsa.edu/10.1089/blr.2011.9992

Reed, Don C. "ARE YOU PARALYZED?" Stem Cell Battles, 3 Nov. 2025, stemcellbattles.net/are-you-paralyzed/.

Scott, C.T. and Magnus, D. (2014), Wrongful Termination: Lessons From the Geron Clinical Trial. STEM CELLS Translational Medicine, 3: 1398-1401. https://doi-org.libweb.lib.utsa.edu/10.5966/sctm.2014-0147.