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ADULT STEM CELL INDUSTRY LEADERSHIP
Stemedica Perspective On Geron's Departure From The Stem Cell Industry
(November 23 2011; Stemedica Cell Technologies, Inc.)
The Geron Corporation, a biopharmaceutical company that was developing cell therapy
products from differentiated human embryonic stem cells for multiple indications,
recently announced that they have decided to exit the stem cell industry citing
financial reasons and what is perceived to be a very long regulatory pathway for
its embryonic stem cell technology
There are many opinions on how this news will impact the stem cell industry. Please read our response below.
Geron Exits Stem Cell Industry: Stemedica Response
Geron’s new CEO has announced that they will focus entirely on the field of oncology and the ongoing clinical trials associated with their technology in this area. He also believes that advancing their stem cell initiative would detract from what has been their original mission as an oncology-focused biotech company.
Geron’s departure impacts the stem cell industry in both a negative and positive way. From a negative point of view, those individuals that do not understand the difference between Geron’s embryonic stem cell technology and Stemedica’s adult allogeneic cell technology tend to place all companies in the industry into the same general stem cell category. As a result, any adverse news in the marketplace from these individuals tends to have a negative impact on the entire industry regardless of its relevance.
Despite the short term attention by the media, and what might be initially perceived as a industry setback, Geron’s exit will ultimately allow companies like Stemedica to gain more prominent recognition for its adult allogeneic stem cells. This, we believe, casts a positive light on the significant progress that is being made in clinical application of adult allogeneic stem cells in demonstrating both safety and efficacy.
As we have documented in our book The Miracle of Stem Cells, there is significant scientific and medical difference between embryonic and adult stem cell technology. The FDA originally halted Geron’s clinical trial citing the formation of cysts and potential safety concerns. Geron was asked to complete more animal studies and eventually was able to demonstrate in at least one animal study that the cysts were not the same kind of formations that originally caused teratomas (pre cancer lesions) in other animal trials using embryonic stem cells. As a result of the additional animal study, Geron was allowed to proceed with their clinical trial for “complete” spinal cord injuries. Enrollment in Geron’s trial was very limited due to the safety concerns previously mentioned.
Stemedica has made great progress in the testing and characterization of its stem cell technology. Independent organizations have subjected Stemedica’s stem cell technology to rigorous safety testing including all viral and infectious disease testing required by the FDA as well as both tumorigenicity and toxicity in vivo testing. In addition, Stemedica engaged an independent research institution to conduct a comprehensive comparison of its neural stem cells with embryonic stem cells. The results demonstrated that Stemedica’s stem cells, when compared to embryonic cells, had identical potency without the risk of tumor formation.
Finally, when the safety of a company’s medical technology is questioned, it is far better for this technology to exit the field than to have it create a “cloud” over the entire industry. In this regard, Geron’s departure from the stem cell industry creates a substantial opportunity for companies like Stemedica that have safe and efficacious products currently being used for research and in clinical trials.
View Geron's press release regarding their decision here