The promise of stem cells is big: One day they could provide a renewable source of cells to help repair or replace tissues and organs damaged by disease or aging. This could ultimately lead to bespoke treatments for diseases ranging from macular degeneration to heart disease.
But the key words here are “one day.” Genuine regenerative therapies are likely still many years off — experts estimate about a decade. And as that decade passes, and people age, their cells accrue DNA damage and mutations. So herein lies a business opportunity: As the reality of regenerative medicine remains on the horizon, Canadian and American biotech companies are offering people an opportunity to freeze their cells today for use in the future.
The Toronto-based start-up Acorn Biolabs launched in April and offers storage for human cells pulled from hair follicles. To use the Acorn service, people pluck a few hairs and mail them to the company’s lab in one of Acorn’s home kits. The lab analyzes the cells to make sure they are “viable for future cell therapy and regenerative medicine,” according to the company, and then freezes them at a temperature of -320.8°F. The cells are stored in tanks that Acorn claims will ensure they remain healthy and available throughout a person’s lifetime.
“Regenerative medicine is the ability to use your own cells to heal yourself,” says Drew Taylor, Acorn’s CEO and co-founder. “Having a source of cells for yourself, that can be used for all of these regenerative medicine techniques and future cell-based therapeutics, is of utmost importance.”
Taylor co-founded Acorn in 2017 with University of Waterloo researchers Steven ten Holder and Patrick Pumputis. While studying cystic fibrosis, ten Holder, now Acorn’s chief innovation officer, helped preserve research samples for future study. He saw the potential of the storage freezers to help him understand his own physiology. “I thought it’d be really neat to put some of my own material in the freezer, just stash it away kinda like a rebel kid,” says ten Holder. “Then at some point in my future, when I’m a postdoc, or hopefully a professor, it could be an interesting paper. The comparison between my own young cells and my own old cells.” He quickly realized there could be a larger application for this idea.
Acorn isn’t alone in its approach. GoodCell by LifeVault Bio is a Massachusetts-based company that launched in May 2018 and uses a one-time blood draw to collect potentially important cells and freeze them for later use. “We believe that blood is one of the best storytellers for your body,” says LifeVault CEO Trevor Perry. “It carries everything to cells and carries everything away from cells.”
Both companies have made a bet that a Nobel Prize-winning technology called induced pluripotent stem cells (iPSCs) will be used to transform their clients’ frozen cells into usable stem cells. Originally developed in 2006 by Japanese scientist Shinya Yamanaka, iPSCs are adult cells that have been genetically reprogrammed into versions that act like brand new stem cells. The technology provides an alternative option for stem cell collection. Rather than relying on embryonic stem cells (which can be controversial) or stem cells from bone marrow (which require surgery to extract), cells from hair or blood can be turned into iPSCs.
“In theory, the overall idea that saving younger cells should allow you, on average, to have lower mutations… is a totally valid scientific concept.”
Acorn charges approximately $222 for the collection of users’ cells and $12 per month to store them cryogenically. GoodCell ships a collection kit for a $499 fee (which can be paid over six monthly installments) and stores the cells for a $149 annual rate. Neither Acorn nor GoodCell plan to offer the iPSC treatments themselves; they’ll simply store the cells until treatments which leverage new iPSCs technology are available. Customers will be able to return to the companies and request access to the stored material.
Stem-cell treatments today
At present, there are some very successful examples of treatments for certain blood cancers. More general stem cell treatments are still very early, with only a few approved by national health regulators in the U.S. and Canada.
Although there are currently hundreds of stem cell clinics around the country, they are offering mostly unproven and expensive treatments that can sometimes lead to tragic consequences. The FDA has sent several warning letters to U.S. stem cell clinics that the agency says are providing unproven treatments that haven’t been proven for safety or efficacy.
Beyond the borders of Canada and the U.S., there’s also a growing industry of black market treatments in countries with looser health rules, inspiring something called stem cell tourism. Experts tell Elemental that in the future it will be challenging — if not impossible — to separate the claims of legitimate companies from those offering unsafe options. “This is a consumer protection issue,” says Ubaka Ogbogu, health law and policy professor at the University of Alberta. “They’re using science-sounding content to build a market” for something that is still as much hypothetical as it’s based on clinical evidence.
Freezing for the future: challenges and caveats
It remains unclear whether people’s thawed hair and blood samples will work as well as the companies claim.
“In theory, the overall idea that saving younger cells should allow you, on average, to have lower mutations… is a totally valid scientific concept,” says Kristin Baldwin, an associate professor at the Scripps Research Institute focusing on human genomics. The question is whether that actually matters during the future treatment. According to Baldwin, cells naturally accumulate mutations no matter what age you are.
Baldwin adds that the decision to use these services will come down to a cost-benefit analysis. Much like a heart or liver transplant today, it’s unlikely that a large percentage of biobanking customers would need to use iPSC-manufactured transplants in their lives. And if they do, they will always have a large and accessible (but potentially aged) collection of cells in their own body to draw from.
University of Alberta’s Ogbogu says companies like Acorn and GoodCell are not worth the investment. “It is wildly premature to offer banking for future use given that there is no evidence of clinical application of iPSC-based transplants on the horizon,” he says.
On the other hand, what Acorn and GoodCell are offering is much less harmful to the consumer than the black market stem cell treatments in other jurisdictions, says Stacey Johnson, director of communications and marketing at the not-for-profit Centre for Commercialization of Regenerative Medicine in Toronto. It’s a public-private effort between the Canadian government with support from the Province of Ontario and the University of Toronto to help foster the ethical development and commercialization of regenerative medicine-based tech as well as cell and gene therapies.
“I don’t see a way that biobanking is harmful to patients in the way that stem cell tourism has a potential to be harmful,” says Johnson. “Of course, there is the possibility that someone could be out of pocket for a procedure that they never end up using.”