From Peyton Manning reportedly flying to Germany in 2011 for a bulging disk in his neck to Drew Pomeranz receiving an injection in his elbow earlier this year, many have been taking leaps of faith with stem cells treatments outside approved channels. And controversy has followed.
Traveling abroad to receive stem cell treatments outside of those currently approved by the FDA has been getting media attention ever since the promise of stem cell therapies first started making headlines, and these stories are not limited to all-star players either. Earlier this year, a BBC news correspondent said a stem cell therapy in Mexico helped significantly improve the symptoms of her multiple sclerosis, and the Shetland Times has been following one woman who feels a “million times better” after going to the same country to treat the same condition.
What began with so-called destination healthcare or medical tourism has turned into the recent proliferation of experimental treatments centers in the U.S. and an inundation of direct-to-consumer marketing. Why have people been going outside the scope of FDA-approved treatments and clinical trials and what risks are they taking?
Stem Cell Tourists
Peyton Manning may be one of the bigger names, and despite the exact outcome being unknown, it definitely added to the exposure the practice was getting early this decade. Soter Healthcare, a U.S. facility that specializes in destination healthcare services, says this is because the United States has lagged behind other countries in this field:
“For more than 15 years, China has been actively involved in stem cell research, and its scientists and physicians today produce more scholarly papers on the subject than any other nation. In the U.S., stem cell treatment is still years away from approval.”
David Mair is the founder of Soter Healthcare and has long advocated the advancements in other countries.
“The Chinese, the Germans and the Israelis are among the leaders in the world in stem cell care right now,” Mair said in 2011.
Mair also says he has seen the benefits of going abroad for experimental treatments firsthand. His niece was the subject of a story in the Washington Post in 2010 about her treatment in China for cerebral palsy. The father called the developments “unbelievable,” and Mair later summed up many of her advancements:
“Today, she walks with a single crutch,” he said in 2012. “She now can use her left-hand independently for major motor skill range of motions. She walks extended distances, her stamina and walking gait are far better, her vision and voice modulate is much better, and she is reading at her grade-level.”
If this lag in stem cell research in the U.S. is real, it could be because embryotic stem cells—a particular kind of stem cells found in the early stages of gestation—have imbued a bad name on the practice. The way Americans feel about embryotic stem cell research went all the way to the White House, with President George Bush, in 2001, limiting research in that category and President Obama later overturning the former president’s order. Regulations, however, still may be hampering progress.
Dr. Adam Anz of the Andrews Institute for Orthopaedics and Sports Medicine, in Gulf Breeze, Florida, is one U.S. scientist investigating the benefits of stem cells and is looking into how they could repair cartilage in knee injuries. He is just awaiting FDA approval.
“Regulation is good, but that regulation needs to be tailored toward these emerging technologies,” said Dr. Anz, who believes the REGROW act currently under review in Congress will help create more clinical trials by allowing small clinics and university labs to charge for participation.
Warning from experts
While people may think they are simply taking advantage of a treatment that has yet to be approved in their country or their situation is so dire that they have nothing to lose, experts warn against unproven procedures in countries without the proper medical controls. Short- and long-term complications are possible, and there is always the possibility it will make the condition worse or even cause death.
The X-Cell Center is Germany is one institution that seemed to have all the opulent trappings of a well-to-do stem cell treatment center. That was until it was shut down in 2011 by the German government for deaths that occurred in 2010. Since, the X-Cell Center has re-opened in Lebanon under a new name but practicing the same types of treatments.
"Regulatory agencies such as the FDA can ensure that cell therapy that reaches patients is safe (and) effective and that quality control is established for isolating the cells, manipulating them outside of the body, and delivering them," said Jeffrey Karp, director of the Laboratory for Advanced Biomaterials and Stem-Cell-Based Therapeutics at Brigham and Women's Hospital in Cambridge, Massachusetts.
Obtaining adipose-derived stem cells requires a liposuction-like procedure that could feel like a side benefit to some patients
Like Peyton Manning, Chris Johnson, who was then with the New York Jets, also had a stem cell injection. But this one took place at the Andrews Institute in Gulf Breeze, Fla. It’s part of a recent crop of stem cell clinics in the United States that circumvent FDA regulations by using unadulterated stem cells mainly acquired through the patient’s adipose fat cells. This is in contrast to the services in other countries that also use adipose stem cells but multiply their number by some 200 times before re-introducing them back into the body. The FDA warns against treatment using fat-dervied stem cells, saying they are being used “on the basis of minimal clinical evidence of safety or efficacy, sometimes with the claims that they constitute revolutionary treatments for various conditions.”
A study of these types of clinics recently made headlines because of their direct-to-consumer advertising practices, which seemed to proclaim stem cells as the cure-all for nearly everything. The FDA now says it is going to crack down on unscrupulous stem cell clinics while easing the path to approval for legitimate treatments.
International Society for Stem Cell Research (ISSCR), a company that, as the name implies, promotes stem cell research has even come out against these company’s false claims. It proffers these safety tips:
- Beware of stem cell treatments offered without regulatory approval or outside the confines of a legitimate and registered clinical trial.
- Unproven treatments present serious health, personal and financial considerations. Consider what might be lost and discuss these risks with your family and healthcare providers.
- Be wary of clinics offering treatments with stem cells originating from a part of your body unrelated to your disease or condition.
- View clinics that offer the same cell treatment for a wide variety of conditions or diseases with extreme caution. Be wary of claims that stem cells will somehow just know where to go and what to do to treat a specific condition.
- Every medical procedure carries risk; be wary of clinics that gloss over or minimize the risks associated with their treatments.
In addition, we'll note that most clinical trials do not require the patient to pay for the procedure, and stem cell infusions where moeny is exchanged could be a warning sign for any patient.