On January 7^th news broke of a study out of the Wake Forrest University School of Medicine demonstrating the potential therapeutic uses of amniotic fluid-derived stem cells (AFS cells). The author of the study, Dr. Anthony Atala, claims that AFS cells—derived from amniotic fluid or placenta—contain the best properties of embryonic stem cells (ESC) without their limitations. For example, AFS cells have much of the plasticity of ESC, but they lack the propensity of ESC to create tumors. Like ESC they are self-replicating, but they have proven relatively easier to manipulate in animal models. Importantly for many (myself included), AFS cells do not require the destruction of human embryos, as AFS cells are a byproduct of pregnancy and natural birth. Given the potential value of this discovery to regenerative therapy—and the manner in which these cells are obtained—an interesting side effect of Atala’s discovery will likely be to spur an industry of stem cell preservation.

Richard Branson is set to announce this week that he is starting a stem cell bank under the brand, not a little ironically, of his Virgin empire.

To use these cells for therapies, they must be preserved for each patient from the moment of his or her birth. If a fifty-year-old man comes down with diabetes and needs to regenerate his pancreatic cells, an effective way for him to do so would be to use the AFS cells from his birth in the regenerative therapy. Assuming the cell differentiation were to work, his own AFS cells would not cause a hostile immune response. The trouble is: if he is fifty-years old, how is he going to get stem cells he generated in utero? The simplest answer is cryogenic freezing.

Since the 1988 discovery of stem cells in umbilical cord blood, many parents have been cryogenically freezing their newborns’ cord blood (and its stem cells) in private cord banks. This has proven quite effective in combating conditions such as leukemia and sickle-cell anemia. More recently, with the advent of further ASC therapies derived from umbilical cord blood, private sector cord-blood freezing has grown considerably. In the United States alone, companies like Cryo-Cell, Cord Blood Registry, Inc., and ViaCord will collect the cord blood, process it, and freeze it should it ever be needed. Competition in the field is growing, with the leading companies responding accordingly: Cryo-Cell will contribute 4% of storage fees to a personal college savings account for the donor; Cord Blood Registry has a free trial program; ViaCord offers competitive financing rates. The business model is an ingenious one. The only real costs are cryogenic freezing and advertising.

The low overhead and bustling competition is causing larger companies to enter the market. Sir Richard Branson is set to announce this week that he is starting a stem cell bank under the brand, not a little ironically, of his Virgin empire. According to the Times of London, the storage facility will focus on preserving umbilical cord stem cells, which are useful in combating blood disorders. In the current research environment, however, there is no reason for Branson to limit himself to that one kind of therapy, and it is unlikely that he will.

Given Dr. Atala’s claim that he has “shown the [AFS] cells can grow into nerve, blood vessels, liver cells, cartilage, bone and cardiac muscle” there is a diversity of ailments from which a person could suffer long after birth, whose effective treatment could be ensured by AFS cell storage. Should AFS cell therapy become a reality, it is only a matter of time before people begin freezing AFS cells in earnest, which would prove lucrative to the relatively young cord-blood storage industry, which is uniquely situated to provide the service given its existing cryogenic infrastructure. Cryo-Cell, for example, already offers placental ASC storage services. The news out of Wake Forest will make others take notice of the possibilities inherent in storing more than just cord blood stem cells.

AFS cells—derived from amniotic fluid or placenta—contain the best properties of embryonic stem cells without their limitations.

Already, the industry tends toward vertical integration. Most existing cord blood banks are financially tied to larger biotechnology firms—ViaCord is a subsidiary of ViaCell; Cryo-Cell has a financial relationship with Saneron CCEL Therapeutics, Inc. In the future, look for the first biotech firm to derive an effective AFS cell therapy to enter into an exclusive relationship with a storage banking facility. Cryo-Cell already has one such arrangement with the Plureon Corporation in its storage of placental ASC.

Another possible challenge facing the private stem cell storage industry is the possible expansion of public stem cell banks. Already such banks exist—primarily for cord blood stem cells—and they are sure to grow in the future. For those parents unwilling to pay for private stem cell storage, it would not take much inducement to convince them to donate the AFS cells, from either amniocentesis or placenta, to a public storage bank. Whereas privately stored AFS cells would be a certain immunogenic match for a patient down the line, it has been suggested that a sufficiently large public bank of stem cells would have the genetic diversity to serve the vast majority of the public. Such a situation would render private stem cell storage superfluous and would likely stunt any growth in the industry. Nonetheless, in order to obtain the requisite genetic diversity for large-scale “matching,” the bank would need hundreds of thousands of donors. Until such an extensive public bank can be secured, there will continue to be a pressing need for growth in private stem cell storage, since most stem cell therapy would require either stem cells stored from one’s own birth, or someone else’s, acquired through financial transaction with a private storage facility, that are an immunogenic “match.”

While government wrangles interminably with expanding embryo-destructive research, amniotic fluid and adult stem cell research will move closer and closer to effective therapy. Parents will clamor for a way to store these cells, and with them the chance to preserve their children’s lives.  You can take that to the (cell) bank.

Michael Fragoso is a research assistant at the Family Research Council.

Image credit: "Collecting Stem Cells" by Flickr user Sam Blackman