“Are you making money from the media frenzy that surrounds stem cells?”

Glossy ads may liken it to health insurance, but some bioethicists contend that stem cell banking is little more than a roll of the dice. Credit: Jessica Kolman

The pitch, delivered in a high-energy online video, is aimed at would-be sellers of a “stem-cell enhancer” derived from cyanobacteria. But the question could just as easily be put to the crop of private stem-cell banks popping up around the United States.

Stem-cell banks offering to extract and store cells from embryos, menstrual blood, baby teeth and bone marrow are joining the more established umbilical cord blood banks in marketing directly to consumers with slick ads bearing a potent message: our services could save your life—for a considerable fee.

Most of these commercial cell banks are based on some peer-reviewed science and have collaborations with major biomedical institutions. But critics say that many tout breakthroughs that are irrelevant to their claims, gloss over weaknesses, blur distinctions and exaggerate competitors' flaws. In sum, stem-cell banking aimed at the private individual has vaulted into the marketplace before anyone knows whether the cells will be worth the plastic they're cryo-preserved in.

Contrary to many of their claims, the banks' offers represent not so much insurance as a gamble, says Jeremy Sugarman, deputy director for medicine at the Johns Hopkins Berman Institute of Bioethics in Baltimore. Insurance provides a certain benefit for an uncertain future, he says. “Stem-cell banking is providing an uncertain benefit combined with an uncertain future.”

Untried sources

In November 2007, Cryo-Cell International in Oldsmar, Florida, began advertising a menstrual stem-cell extraction and storage service named C'Elle, “where every month holds a miracle.” The website warns: “Diseases in life that seem a long way off today, such as heart disease, osteoporosis, diseases of the nervous system, may strike at any time.”

C'Elle's website points out morphological similarities between the menstrual stem cells shed with the endometrium of the uterus and bone marrow mesenchymal stem cells, and lists conditions ranging from ageing to spinal cord injury that, it says, might one day be treatable with these stem cells. Meanwhile, the site notes that menstrual cells possess two pluripotent markers associated with embryonic stem cells (ES cells), which “may explain the extraordinary proliferative and differentiation capabilities of C'elle menstrual stem cells that seem to reflect their significant potential for clinical cellular therapies.”

Critics contend that so far, only one study describing the menstrual cells has been published. Julie Allickson, vice president of laboratory operations, research and development at Cryo-Cell, says the company is collaborating with preclinical research on diabetes and neurodegenerative diseases and that her own research on the cells' differentiation and proliferation is now in press. “I think it's a great cell source because it's non-controversial,” she says. “And if you weren't storing it, it would be going into the garbage.”

Austin, Texas-based BioEden is tapping another stem-cell source that would otherwise be thrown away: baby teeth. “One day, the Tooth Fairy could save your child's life,” its website asserts, as a lab-coated scientist with fairy wings looks on.

Mike Byrom, BioEden's chief scientific officer, says the 12 non-molar baby teeth that fall out of every child's mouth offer a pristine source of several valuable cell types, particularly mesenchymal stem cells. In contrast, he says, available stem cells from a 40 or 50 year old have been “exposed to a lifetime of environmental toxins.”

Unlike insurance, many of the stem cell banking initiatives are more like a gamble. Insurance is there to provide a certain benefit given an uncertain future. Stem cell banking is providing an uncertain benefit combined with an uncertain future. Jeremy Sugarman

Byrom likens the situation to the early days of cord blood banks and is steadfast in his belief that the baby-tooth system will eventually pan out. “The reality is that these are a rich source of stem cells,” he says. “And with all of the applications for stem cells, something—if not multiple therapies—will eventually be approved.”

Lawrence Petz, chief medical officer at StemCyte in Arcadia, California, agrees with Byrom on the established value of cord blood banks. The company's hematopoietic stem cells have been used for thousands of successful transplants, Petz says. But he's not convinced that menstrual blood or baby-teeth stem-cell banks are worthy successors. “I think these things are just different gimmicks,” Petz says.

StemCyte, with about 27,000 units in its public cord blood bank, also offers a private option called StemCyte Family. It informs expectant parents that banking their baby's cord blood preserves “a unique biological resource that is like a 'self-repair kit' for your child, and possibly your entire family.”

“As a company, we've done more transplants than every other family bank combined—twice as many,” says David Carmel, StemCyte's vice-president of business development. But what StemCyte fails to make clear is that all those hematopoietic stem-cell transplants provided an infant's banked cells to someone else, either a relative or a stranger.

Such transplanted stem cells, in the form of cord blood or bone marrow, have figured prominently in a long list of treatments and cures, from rebooting a leukemia patient's immune system to treating inherited blood disorders such as thalassemia. However, private banking of cord blood stem cells for the individual's own use has been panned by experts, who say there is little evidence that patients benefit from treatment with their own, potentially faulty, cells. The American Academy of Pediatrics discourages private storage of cord blood as biological insurance, particularly given that cord blood is available from other sources.

Unanswered questions

Like its competitors, then, StemCyte Family's pitch relies on the unanswered question of whether banked stem cells can be coaxed to transform into other cell types, let alone ones with clinical relevance for spinal-cord injuries, diabetes, Parkinson's and other diseases for which stem cells have been touted as potential therapies.

It could turn out that cord blood cells just make more bone marrow, and stem cells from baby teeth just make more teeth. BioEden is now collaborating with a British company called Odontis, a spin-off from research at King's College London, to try the latter. But BioEden and its competitors aren't shying away from broader claims. Nevertheless, the evidence that adult stem cells can switch lineages “has not been spectacular,” says Mahendra Rao, vice-president of stem-cell research and development at Invitrogen in Carlsbad, California.

Ana Krtolica, head of San Francisco-based StemLifeLine, which creates and banks human ES cells, has been able to neatly sidestep that criticism. The ES cell bank, Krtolica says, began as a service for would-be parents who had already ponied up US$15,000 to $20,000 for in vitro fertilization and wanted a use for their extra embryos. So far, ES cells have boasted the broadest therapeutic potential and potent proliferative ability. “No matter how many cells you need for therapy, you will have them in unlimited numbers,” Krtolica asserts. “And that's not true for the adult stem cells.”

Apart from the expense, however, her service has attracted considerably more ethical scrutiny than some other banks because, until recently, creating the stem-cell lines required the destruction of an embryo—a controversial procedure that Krtolica's competitors are fond of emphasizing.

And of course, no therapies using ES cells have yet been developed. “It's way too early to say in a sales pitch that we're going to bank your cells and if your child, or X, Y or Z in your family gets muscular dystrophy, there's going to be a ready supply of cells to treat it,” says Christopher Scott, director of the program on stem cells in society at the Stanford Center for Biomedical Ethics in California.

Of the current batch of stem-cell banks, New York's NeoStem boasts of being the first to provide services for the “general adult population,” from whom it offers to collect hematopoietic stem cells released from bone marrow. Its competitors, in turn, highlight the more unpleasant aspects of such donation, including the bone pain associated with the regimen used to stimulate the cells' migration from the marrow to the bloodstream. StemCyte's Carmel notes that the collection process could last 8 hours.

On the basis of her own experience, NeoStem's chief executive officer Robin Smith asserts that the procedure lasts less than 3 hours and is like self-administering insulin and then donating blood. And she cites bone-marrow transplantation's solid benefits, such as its ability to treat a range of autoimmune diseases, cancer and radiation exposure.

“If, God forbid, you got leukemia or there was a dirty bomb in New York, then your mesenchymal stem cells can't make you a new immune system,” Smith says. Nor is she keen on cord blood, pointing out the inherent limitation on how many stem cells can be collected. StemCyte's Petz parries this by attesting to the expanding practice of using cord blood from two donors to treat adults.

Amid the tit-for-tat, stem-cell banks for yet-to-be-developed therapies face another problem. Even if therapies are developed, “stem cells derived with today's methods and medical approaches may be completely inappropriate for future applications,” Scott says.

The banking companies say they follow FDA Good Manufacturing Practices, which should allow the stored cells to be considered for future therapies. But Invitrogen's Rao, who heads an International Society for Stem Cell Research committee on the translation of stem cells into clinical use, says those FDA guidelines were set up primarily for drug development and not for the uncharted waters of stem-cell procurement and storage. Given the reluctance of the federal government to address stem-cell banking regulations, organizations such as the ISSCR have been left to fill the gap. Rao's committee is expected to issue a report this summer. “The example I use is that for a good game you need strong refereeing,” he says. “It's very hard for one competitor to referee someone else.”

In the meantime, the field could see a shoving match as banks jockey for position. Consumers, on the other hand, are likely to hear more about their own uncertain futures, and see more adorable babies and beautiful nude women gazing into the camera—and even dogs and horses pitching a version of that “all-natural” stem-cell enhancer “for today's pet health needs.”