Gone are the times when Americans embarked on “stem-cell tourism” to obtain stem-cell driven treatment for their medical conditions from remote places like Mexico, the Caribbean and China. Now, people are merely required to commute locally to receive unapproved stem cell treatments.

Experts in Bioethics and Pediatric Stem Cells from the University of Minnesota and University of California Davis recently carried out a study to spot clinics and companies across the US which offer expertise in unproven stem cell treatments.  The comprehensive study was also recently published in the journal Cell Stem Cell.

Researchers in this investigative study were surprised to find as many as 351 US businesses engaging in direct-to-consumer marketing of stem cell interventions which were being practiced at 570 clinics.

As the field of regenerative medicine continues to evolve, the magical property of stem cells to proliferate into specialized cells and tissues enthralls experts and public alike. Despite the efficacy of stem cell treatments at a laboratory level many regulatory steps need to be cleared for the treatment to reach clinical practice.

However, many businesses and clinics are still flourishing in their unauthorized pursuit of providing stem cell treatments to patients suffering from varied ailments. Attributed to the ability to divide into all kinds of specialized cells, the potential of regenerative medicine is huge, but the risk of this treatment cannot be ignored.

The placenta and a newborn’s umbilical cord are rich sources of embryonic stem cells while bone marrow, which replenishes immune cells and blood cells, is rich in hemopoietic stem cells. Additionally, certain tissues like bone, fats, muscles or nerves are also home to adult stem cells. These naturally-occurring stem cells help us stay fit after an injury or ailment. Fortunately, lab-induced pluripotent stem cells have been able to program mature stem cells to absorb the properties of embryonic stem cells and provide assistance in conditions like cancers and bone injuries.

In either case of autologous (stem cells taken from the patient) or allogeneic (stem cells from a donor) stem cell treatment, if a stem cell treatment goes wrong, the uncontrollable proliferation of stem cells can induce tumors which spread into different organs on the body. But as the business of unapproved treatments continues to thrive, it seems like patients and even treatment providers are not aware of the life-limiting adverse effects of stem cell treatment.

These dubious businesses and clinics offer both autologous and allogeneic stem cell treatments. Out of the advertised autologous stem cell procedures, 61% of adipose-derived stem cells-based procedures, 48% of bone marrow-derived stem cells and 4% of the interventions used stem cells from peripheral blood.

The hot spots for these clinics were California, Florida and Texas, with 113, 104 and 72 clinics, respectively.  Other places with similar clinics included Beverly Hills, New York and San Antonio.

These clinics were also smart enough to advertise their ideas across all age groups. Claiming to be offering anti-aging cosmetic treatments to athletes and targeting orthopedic and sports medicine, the treatment interventions had something for everyone.  Neurological disorders, degenerative conditions, spinal cord injuries, cardiac and pulmonary problems, immunological, urological diseases were just a few of the conditions they claimed to have a treatment for.

Sadly, their marketing was a manipulative strategy aimed at parents desperate to get their ailing children treated.  Informed adults who would have otherwise critically analyzed the offered treatment were now having their emotions and wallets exploited.

The researchers said, “We found nine clinics each promoting stem cells for autism and for cerebral palsy. We also identified 33 marketing claims for muscular dystrophy (MD), a disease that primarily though not exclusively afflicts children.”

It was unfortunate to witness such exploitation, when in reality, the stem cell research for muscular dystrophy, autism or cerebral palsy is only in its initial laboratory research phase.

Given that these practices were not supported by peer-reviewed evidence and worked on the lines of emotional manipulation, a lot of ethical and legal concerns were associated with the treatment.

Interestingly, the Food and Drug Administration (FDA) has only approved a few stem-cell procedures on paper. The role of regulatory authorizes was questioned as they failed to shut down clinics and businesses that were playing with human lives.

A debate has been triggered over the role of drug regulatory authorities after this development.  Some said that it is important for FDA to intervene in the situation while others criticized the regulatory policies of FDA.  In this regard, Marc Scheineson, a former top FDA official said that the current FDA regulatory regime is archaic and is stifling medical innovation.

In response to the heated debate, FDA has taken notice of the situation and has called for two public meetings in September to draft guidelines on stem cell treatment.

Dr. Aaron Berkowitz and colleagues at Brigham and Women’s Hospital in Boston commented at the gravity of the issue, “The unregulated commercial stem-cell industry is not only potentially harmful to individual patients but also undermines attempts to study stem-cell therapies in clinical trials.”

With the exposition of ethical and legal violations carried out by unproved stem cell businesses and clinics, the fate of stem cell treatment in the US is at stake. The US government’s stance in the coming days will give us concrete evidence of the future of stem cell treatments in the country.