Dental stem cell banking is a small but rapidly emerging trend in the regenerative space. Marketing about potential uses of these tooth cells often has gotten way ahead of the science.
Some clinics and cell banking firms are already suggesting dental stem cell banking as a source of cells to treat specific health conditions yet there are no proven uses. It’s not clear that the cells involved are even stem cells in many cases. In part, it depends on how you define “stem cells”.
Now an investigation by The BMJ has turned a magnifying glass on three UK companies involved in baby tooth cell banking. After read the resulting paper and doing some searching, I realized that dental stem cell banking is fairly widespread in the US too.
Possible risks to the public are growing in this space.
Here’s the paper: Banking baby teeth: companies may be misleading parents with “outrageous claims”. It discusses many reasons for concern in this area.
What is dental stem cell banking?
Before we discuss the investigative paper, what are these dental cells and are they even stem cells? Why are they banked?
Tooth stem cell banking focuses on isolating cells from baby teeth. Sometimes these are called milk teeth. As these teeth just fall out, they are a potentially easily available and useful source of cells.
Importantly, the cells from the pulp of baby teeth often appear more similar to mesenchymal stromal cells rather than stem cells. As a result, it’s up in the air as to how many, if any, are true stem cells for any given person or tooth.
The cells are isolated from tooth pulp after parents send in newly fallen out teeth from their kids. Many firms bank cells from adult wisdom teeth as well.
In both cases, the pulp cells are often grown in a lab before cryopreservation in liquid nitrogen. There is some mention of FACS analysis or flow cytometry to assess or sort the cells, but I don’t see much detail on what is actually done and whether this provides good evidence that these are actual stem cells. Without flow sorting, the populations are unlikely to be just one cell type. Actual stem cells may only represent around 1% of the cells in dental pulp.
The cells don’t necessarily have to be stem cells to be useful, but either way their safety and usefulness need to be proven before marketing.
The core commercial idea here is that if a person needs some kind of cell therapy in the future, these frozen tooth cells might be a valuable source. It’s very similar to marketing for cord blood banking.
The investigation and the 3 firms selling dental stem cell banking
The BMJ researchers began looking into the practice of dental cell banking there in the UK, ultimately publishing the paper that focuses in part on the marketing. They discussed three firms:
“The BMJ found that the three companies in the UK (see box 1) offering tooth stem cell banking—BioEden, Future Health Biobank, and Stem Project—all operate through one laboratory. The Advertising Standards Agency (ASA) says it will review concerns we have raised about how the service is promoted on their websites.”
Hopefully, the ASA will take some action there.
These three firms have different websites with distinct claims, but overall the common concern here is that unproven applications of tooth “stem cells” are being inaccurately portrayed as available clinical options for many conditions.
The BMJ piece notes that websites mention autism, HIV/AIDS, cleft palate, and diabetes as well as other conditions. There is no good evidence that baby or milk teeth cells can treat these things.
The paper noted the autism claims as particularly concerning:
“But several experts have told The BMJ that they are concerned about the claims being made, which risk exploiting parents—with the promise of a treatment for autism deemed particularly outrageous.”
There are so many folks out there who seem willing to take money from families with autistic children for injecting various unproven cells.
Tooth pulp cells and cord cells lead to unsupported claims
It’s interesting here that some have compared tooth MSCs to umbilical cord cells, and both have been marketed for autism. There’s no good evidence to support that in either case. The idea of stem cells for autism has been disappointing so far.
Why is this an important issue? When cells of any kind including tooth cells are hyped, people get the wrong idea. It can lead to false hope and erosion of trust in biomedical science. Families may take medical risks with little chance of benefit.
There are financial risks too. Regarding the cost of dental cell banking:
“Consumers sign an agreement before being sent a collection kit when their child’s tooth becomes wobbly. There is an initial cost of around £1900 (€2189; $2573) and an additional annual storage fee of £95.”
This can add up over the years. As with cord blood banking, I imagine families are later faced with dilemmas as to whether to keep on paying. Parents have reached out to me about whether to keep paying for already stored cord blood. There’s no easy answer.
Dental cell research and therapies
It’s worth noting that even for cord blood cells, which have proven utility for use in immune system reconstitution (akin to a bone marrow transplant after chemo for cancer), there is growing evidence that most families who bank such cells never need them. This is even more likely to be the case for banked tooth cells given there are zero proven uses for them.
I want to be clear that some tooth stem cell research is quite interesting. For example, research on using stem cells to make replacement teeth has promise. It is possible that dental cells could help treat things like gum disease as well. So, I’m not dismissing this area of research, but it’s too soon for commercialization.
Some in the field call some pulp cells from milk teeth “SHED” or stem cells from human exfoliated deciduous teeth. I believe it’s likely that there are some stem cells in the dental pulp of some teeth, but if most firms do not do flow cytometry to isolate and expand just those, what is banked is likely a heterogeneous mix that is mostly not stem cells.
Another acronym, DPSC for Dental Pulp Stem Cells, usually refers to cells from wisdom teeth but can also be used more generally.
What dental professionals say?
The American Academy of Pediatric Dentistry (AAPD) policy on dental cell banking recognizes the theoretical potential of dental cells for clinical use in the future, but rightly says, “there are no treatments available using harvested dental stem cells in humans.”
It adds, “the process of procurement of dental stems cells should be accomplished only with deliberate integrity and appropriate informed consent to assure the highest ethical standards and quality of outcomes.”
That consent should be upfront about possible clinical applications remaining unproven.
US dental stem cell banking: Stemodontics and many more
As I mentioned earlier, dental stem cell banking is growing in the US. I had no trouble finding numerous firms just here in California and even here in the Sacramento area that market this on the web.
Some of this banking is done via oral surgeons or dental practices that send the teeth to bankers. Stemodontics is one firm that kept popping up on the web as I did searches.
The marketing here is for a form of biological insurance, which is often like the marketing of cord blood firms.
I found a dental practice right here in Sacramento that offers stem cell banking. The verbiage on its website about stem cells seems nearly identical to that I found on other dental practice sites. Multiple clinics or practice sites may be using the same marketing firm.
Much of the marketing in the US seems more cautious about clinical applications than what was found in the UK so that’s something. However, I still believe that some of the marketing here is over the top. For example, the Stemodontics website says “Stem cells found naturally in wisdom teeth have the proven ability to regenerate and repair diseased tissue and organs.” What is the evidence for this big claim for “proven ability”? What organs can tooth stem cells repair?
A role for the FDA?
I wasn’t able to determine if well-known stem cell bankers ultimately freeze a relatively pure, sorted population of dental cells or not. FACS may be done just to look at markers.
While dental cells appear to most often be intended to be used in an autologous fashion (you get your own cells), the common lab processing used could make these be defined as cellular drug products.
If the cells are generally grown in a lab, it likely makes them more than minimally manipulated. In addition, there would be few homologous uses of dental stem cells or other tooth cells other than trying to make new teeth and maybe a few other things mouth-related. Many firms seem to focus on potential clinical applications unrelated to oral health, which would be a non-homologous use.
All these factors point toward a possible drug classification from the FDA. To my knowledge, no firm has FDA approval to market dental stem cells as a medical treatment. So when dental cells are used clinically in the US, is it often unauthorized use of biological drugs?
Dental cell banking alone is likely FDA-compliant
Note that banking firms do not appear to actually use dental cells on people or provide them for that purpose by clinics. More generally, the banking websites mainly make claims about possible future clinical uses. In this sense, they may be FDA compliant. Only the agency makes such determinations.
I wonder though: are bankers open to shipping banked cells to a clinic now for a non-FDA-approved “therapy”? Perhaps not.
The reason I ask is that some clinics in the US are now marketing the use of dental cells for human health conditions. Where do these cells come from if not from dental cell banks of some kind? Some of the clinics may process the teeth and cells themselves, which could raise GMP issues.
If a dental practice or clinic is directly using non-lab grown, minimally processed dental cells in an autologous fashion for an oral health application, it could be that those cells are not a drug.
More generally, cord blood bankers and other banking firms are expanding the types of biologics they bank, and they may bank dental cells as well. There is also more talk about cryo-banking of MSCs as well from a variety of sources.
With no proven clinical uses, dental banking seems unlikely to be worth the money for most people now.
Again, research on dental cells is worth following moving forward. There are also many clinical trial listings focused on dental stem cells. To me the ones that make the most sense are those testing the use of these cells in oral health conditions like gum disease and such.
References
- Banking on teeth – Stem cells and the dental office. This paper is way too exuberant about dental stem cell banking, but it is still a useful resource. It also lists common dental stem cell banks.
- The American Academy of Pediatric Dentistry (AAPD) policy on dental cell banking policy on dental cell banking.
- PubMed results on “dental stem cells”
- Clinicaltrials.gov listings focused on dental stem cells.
Great article, Paul. Thanks. Every time I think the stem cell grifters have hit bottom, one of them says, “Hold my beer.”