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Stem Cell Exploitation

Unproven therapies, cosmetics present challenges for regulators worldwide

by Britt E. Erickson
December 9, 2013 | A version of this story appeared in Volume 91, Issue 49

A map of the world where several regions are named and have numbers attached to them.
More than half of the nearly 5,000 regulated stem cell clinical trials under way in the world are taking place in the U.S. NOTE: Studies taking place in multiple locations are counted in each applicable region. Data are as of Dec. 2. Regions are defined by SOURCE:

Hundreds of clinics have sprung up, primarily in developing countries, claiming to provide “effective, routine, and low-risk” stem cell therapies to cure nearly any disease imaginable. Similarly, cosmetics, such as facial creams and serums, as well as liquid oral supplements and capsules, have flooded the marketplace, claiming to provide antiaging effects by enhancing stem cell production.

This proliferation of stem-cell-based products and therapies during the past five years has left government agencies around the world struggling to develop or modify regulations to better deal with the nascent technology. The problem is getting worse, observers say, as more and more desperate people travel abroad seeking unproven, possibly dangerous, stem cell treatments for serious diseases.

What makes the situation especially confusing for people is that thousands of legitimate stem cell therapies are in clinical trials across the globe. These trials are registered with oversight bodies, and patients are monitored posttreatment to determine the effects of the therapy. Clinics offering unproven stem cell therapies often look like the legitimate ones.

Legitimate stem cell therapies “hold tremendous potential for a wide range of illnesses,” says R. Alta Charo, a professor of law and bioethics at the University of Wisconsin Law School. Well-intentioned researchers, however, who are committed to developing stem cell therapies via the traditional drug approval pathway, are at a huge disadvantage when their direct competitors market products without having to go through the time-consuming and expensive regulatory process. Such competitors have become increasingly sophisticated and organized in their attempts to sidestep established regulations.

The scope and urgency of the problem as well as the opportunities for ensuring the safety and quality of unregulated stem cell therapies came to light during a workshop last month. The session was chaired by Charo and organized by the National Academy of Sciences, the Institute of Medicine, and the International Society for Stem Cell Research. Scientists, lawyers, and people who sought such treatment from around the world shared their experiences, confirming that stem cell exploitation is a global phenomenon with deep financial and political support that makes it particularly challenging to regulate.

It is unclear what kind of stem cells, if any, unproven stem cell therapies contain. Most of their practitioners have no scientific evidence to back up their claims, and they rely heavily on personal testimonials. Stem-cell-activating skin creams and supplements are widely available on the Internet, typically for less than $50. But those who are seeking cures to life-threatening diseases are spending as much as $50,000 per treatment, plus the cost of travel, to receive unproven therapies at various clinics around the world.

It is hard to say exactly how many unregulated stem cell clinics there are, where they are located, or how many people visit them each year. “It is very difficult to get exact numbers because it is largely an Internet-based industry. A lot of these companies are in jurisdictions where it is hard to get access to them,” says Timothy Caulfield, Canada Research Chair in Health Law & Policy and a law professor in the School of Public Health at the University of Alberta.

Caulfield and his colleagues have used media reports as an indirect way to determine where unproven stem cell therapies are being performed and where people who choose to undergo them are coming from (Nat. Biotechnol. 2010, DOI: 10.1038/nbt1210-1243b). On the basis of their analysis, the majority of the clinics appear to be in China, with increasing numbers in India, Mexico, and the Dominican Republic. They found that people are traveling primarily from the U.S. and the U.K., with some also coming from Australia, New Zealand, and Canada.

graphic showing important numbers about stem cell therapy

The majority of those seeking stem cell treatments are traveling from developed to developing countries, notes Alan Petersen, a sociologist and professor at Monash University, in Australia. Petersen has spent the past four years studying the dynamics of what’s referred to as the stem cell tourism industry. But some clinics are also exploiting regulatory loopholes in developed countries, including in the U.S. and Australia, he says.

The U.S. Food & Drug Administration, which has jurisdiction over human-cell-based therapies in the U.S., has sent warning letters to many domestic clinics that offer stem cell therapies, says Margaret F. Riley, a professor of food and drug law at the University of Virginia School of Law. In these cases, stem cells are mixed with other agents before being administered.

Under current U.S. regulations, if a cell is more than “minimally manipulated,” FDA considers it to be a biologic or drug that needs to go through its lengthy drug approval process. In the European Union, the European Medicines Agency (EMA) has a similar regulation, which applies to cells that have been “substantially manipulated.” The phrases “minimally manipulated” and “substantially manipulated,” however, are open to interpretation and provide loopholes that are exploited.

People from the U.S. and Canada often travel to Mexico to receive stem cell therapies, says María de Jesús Medina Arellano, a postdoc at the Autonomous University of Nayarit, in Mexico, who has been studying the situation. In nearly every case, the therapies people receive in Mexico are advertised as proven treatments and are not registered as clinical trials, she notes. She emphasizes the importance of making people aware that they are receiving experimental treatments.

In some parts of the world, exemptions to stem cell regulations are permitted. For example, in Italy, hospitals can use an unproven stem cell treatment in individual patients outside of a clinical trial, says Paolo Bianco, a professor of molecular medicine at Sapienza University of Rome. Likewise, last year the Texas Medical Board approved regulations that allow doctors in Texas to perform unproven stem cell procedures as long as they have approval from an institutional review board.

These exemptions concern scientists who believe unproven therapies should not be marketed. They say that such deregulation of stem cell therapies is being promoted for financial gains and that political support for deregulation runs deep.

Last year in Texas, for example, language was inserted into the state’s regulations allowing doctors to charge patients commercial rates for stem cell treatments they receive during clinical trials. The language also ensures that doctors won’t lose their medical license when a stem cell therapy doesn’t work.

Regardless of how stem cell therapies are regulated, whether based on approval by an institutional review board or by a federal body such as FDA or EMA, the promulgation of false advertising needs to be stopped, observers say.

In the U.S., advertising of stem cell products and therapies is under the joint jurisdiction of FDA and the Federal Trade Commission (FTC). A problem, however, is that “those two agencies don’t always act together,” UVA’s Riley says.

FDA has taken action against individuals for advertising treatments based on unapproved stem cells. FTC has not. The reason, says David C. Vladeck, a law professor at Georgetown University Law Center and former director of FTC’s Bureau of Consumer Protection, is that FTC has not received many complaints. During his four-year tenure at FTC, which ended in December 2012, Vladeck says he saw virtually no complaints about stem cell therapy. “This is not yet on the radar of the FTC,” he says.

Nonetheless, companies involved in advertising stem cell therapies in the U.S. have a good understanding of U.S. law, Vladeck warns. Many of the websites offering stem cell therapies have “a litany of disclaimers tailored to escape U.S. regulation,” he says. “These are sophisticated operators who understand the dynamics of U.S. law.”

That level of sophistication doesn’t surprise people who have seen this kind of exploitation before. “Anytime there is a scientific development that is exciting or sexy, people use it to profit,” Caulfield says. That was the case with electricity, magnetism, and radioactivity, he notes. Today it is happening with stem cells.


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