The researchers believe that this explosion of illegal business can contribute to discredit stem cell research to the public.
US – At least 351 companies in the US are selling stem cell treatments not approved in 570 clinics. These firms announce interventions for orthopedic injuries, neurological disorders, heart disease, immunological disorders, lung problems, spinal cord injuries and cosmetic indications, according to an article published in the journal Cell Stem Cell.
In this article, the bioethicist at the University of Minnesota Leigh Turner and Paul Knoepfler of University of California, presented an analysis of US companies engaged in direct sales to consumers of these procedures.
Knoepfler said that in most states, people can access treatments stem cells. People of the largest metropolitan areas only have to drive fifteen minutes to find a clinic that offers such services without having to travel to Mexico or the Caribbean.
Turner and Knoepfler found these businesses through keyword searches on the Internet, text mining and content analysis of web pages. For each company, they registered the company name, location, website addresses, advertising types of stem cells, and marketing claims announcing treatments with these methods.
Among the key findings, the report concludes that the highest concentration of clinics offering these treatments to consumers is in California (113 clinics), Florida (104), Texas (71), Colorado (37), Arizona (36), and New York (21).
Among the stem cells procedures stem that are sold include offer interventions cells derived from fat and 48% based on bone marrow treatments; offered by 61% of the companies. Pluripotent stem cells and embryonic xenogeneic procedures are rare and offered by only one or two companies.
More than 300 of the interventions offered relate to orthopedic problems. Others are related to pain (150 companies), sports injuries (90), neurological diseases (80), and disorders of the immune system (75).
Turner said it’s a market that is expanding dramatically before our eyes. He added they were aware of this growth, but never imagined the scope and size was that significantly large.
He wondered where are the regulators since it is assumed that interventions based on stem cells and medical devices that produce them must be regulated by the FDA.
Turner and Knoepfler author of the blog The Niche- began to suspect an increase in stem cell clinics in the USA when their readers stopped referring to treatment abroad and began to inquire about treatments in the country.
In researching the profile of people who are run clinics, the authors found that it was mainly cosmetic surgeons. They also found that the ‘pioneers’ of this industry were training others to do the same. They are alarmed as to how it is unclear whether the federal authorities, particularly the FDA- and medical advice are aware of the extent of the problem or are taking minimum measures to exercise control of the spread of these businesses.
From 2009 to the present, these firms have entered the market and have made routinely marketing saying they can treat between 30 and 40 stem cell disease no one has taken significant regulatory measures, said Turner.
The investigator considered it very serious that people have access to some interventions that are not safe, because they have not been tested or approved.
A further disadvantage is that patients who have opted for these illegal stem cell treatments decrease their chances of being classified for FDA clinical trials that comply with approved federal regulations. “This will be a loss for research in this area,” he said.