Commercial Stem Cell Therapies

There are indeed several stem cell and regenerative medicine therapies that are already on the US market. Maybe not what you expected, but sure enough, these companies offer therapies to help Fido, Fluffy and other 4-legged animals. Hopefully, someday soon there will be companies that offer therapies to help you and me.

It’s hard to keep track of the most recent developments in the area of stem cell therapies, but one that caught my eye was that a potential treatment for Amyotrophic Lateral Sclerosis (also known as ALS or Lou Gehrig’s Disease). A trial for this treatment, which uses neural stem cells, was started in 2009 and has shown promising results thus far, and the trial will soon be investigating potentially life-saving applications of this treatment (preserving breathing ability). Neuralstem has a quick video describing what they believe is happening in patients.

Since stem cell culture is not a mature field, there is a huge variety of culturing techniques that are used. Neuralstem and other companies that are beginning to enter clinical trials, have come to realize that one of the best ways to cultivate stem cells for human therapies is to eliminate serum. In one of their patents, they state:

“Neural cells in culture are highly plastic. Even a brief exposure to suboptimal culture conditions such as serum can have subtle yet significant long-term effects on the phenotype of the cells. Yet, almost all of the reported neural cultures employ serum as the primary source of mitogen. We and others have demonstrated that, in order to preserve the intrinsic differentiation potential of stem cells and other cells, it is critical to reduce the exposure of the cells to serum.”

Well said! The importance of using serum-free stem cell media will be of growing importance as more of these products enter the clinic. It will be interesting to see how far the FDA allows companies to go with serum-containing processes. Serum has long been phased out of new processes for large-scale biomanufacturing of human therapeutics; is it possible that the FDA will allow stem cells that are injected into humans to be in contact with serum? Only time will tell, but going serum-free seems like a good choice.