The stem cells in cord blood are currently approved by the FDA for the treatment of nearly 80 diseases, but they are still showing a lot of promise in a number of other conditions from multiple sclerosis to autism. There is a lot of excitement around the possible future uses of cord tissue, which has stem cells that can become new neural, bone, fat and cartilage tissue and could be utilized in things like sports injuries and severe burns.

Unfortunately, the years between the initial promise shown in these stem cells (especially as they are quick to make headlines) and full FDA approval as a safe and effective therapy has led some people to seek treatments outside current FDA-approved channels. This can involve going to another country to receive a treatment that has yet to be approved in the U.S. or taking part in a treatment that is not a part of an FDA-approved clinical trial.

Drew Pomeranz has made a bit of a comeback after receiving a stem cell infusion for an injury to his elbow

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 centers in the U.S. practicing what some would consider to be experimental treatments. With them has come an inundation of direct-to-consumer marketing proclaiming benefits that go beyond current research. Let's look at why people have been going outside the scope of FDA-approved treatments and what risks they are taking.

Stem cell tourism

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 earlier 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. Today, Mair says the gap has decreased, but we're still lagging behind other nations.

Mair 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.”

Family Guy put the blame on funding although much of its portrayal on the subject, in a typical manner, was over-exaggerated

If this lag in stem cell research in the U.S. is real, it could be because embryonic stem cells—a particular kind of stem cell found in the early stages of gestation—and various ethical considerations raised in their use have imbued a bad name on all stem cells. The way Americans feel about embryonic 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 despite cord blood–derived stem cells, stem cells that form just a little bit later down the road from embryonic stem cells and can be procured with no harm to the baby or child, not having the same ethical considerations or roadblocks.

Dr. Adam Anz of the Andrews Institute for Orthopaedics and Sports Medicine, 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 in Congress could help create more clinical trials by allowing small clinics and university labs to charge for participation.

The REGROW act would provide parents with better access to trial therapies and lead to accelerated adoption of stem cell treatments.

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 procedures that have yet to fully vetted 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.

Homegrown treatments

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 is a three-time NFL Pro Bowler and once raced a cheetah for a National Geographic segment, also had a stem cell injection. But this one took place in Gulf Breeze, Fla. It is one of many new stem cell clinics in the United States that sidestep FDA regulations by using unadulterated stem cells mainly acquired through the patient’s adipose fat cells. This is in contrast to similar 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-derived 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 some 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.

Mair agrees that these unauthorized clinics need to be shutdown but the FDA needs to be careful to not put restrictions on all clinics for a few bad actors. Mair spoke specifically about a case in Florida where three women were left nearly or totally blind after mesenchymal stem cells from their adipose fat tissue were injected into their eyes.

"We can't allow stuff like what happened to those women in Florida," said Mair. "I'm O.K. with mesenchymal stem cells used in osteoarthritis where global evidence suggests that it is a very strong alternative for people in their 40s and 50s who need a knee replacement," he added.

Safety tips

International Society for Stem Cell Research (ISSCR), a company that, as the name implies, promotes stem cell research 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.

As we see it, stem cell research is still 27 years young and has much further to go. As the FDA process ensures that treatments are safe and effective, we must put faith in its methods even if it causes some delays. The FDA's oversight and tracking of outcomes in stem cell transplantations has led to safer treatment options for everyone, and participation in multiple clinical trials is an important step in proving the safety and efficacy of therapies for the general public. We do realize the some people may feel as though they are in a situation where they cannot wait for full FDA approval. For the rest, we will look for the day when these cord blood and cord tissue transplantations will have gone through the required protocal and be included in the arsenal of standard stem cell treatment options currently available.