Study Shows Astounding Increase in Unapproved Stem Cell Treatments

FJ Thomas

Sarasota, FL ( – Around 20 years ago, stem cell therapy became an available treatment option with the promise to repair and regenerate damaged tissue. At that time, as a new treatment, stem cell products were unlicensed, unproven, and unregulated.

In 2017, the FDA issued a progressive regulatory statement to “exercise enforcement discretion” of regenerative medical products. With a scrutiny on stem cell treatments, it wasn’t long before indictments were handed out, such as in the case of Ashton Derges who marketed stem cell treatments for COVID-19 and other conditions. As science has increased, so has the need for oversight.

Stem cell treatments have successfully been utilized for a whole host of medical issues from Multiple Sclerosis to traumatic spine injuries, just to name a few. While the FDA recognizes the potential of stem cells in medical treatment, to date only 22 stem cell treatments are formally approved by the FDA. However, according to a report written by University of California researcher Leigh Turner, there are now more than four times as many businesses offering non-approved stem cell products than there was five years ago. The report, which appeared in this month’s edition of Cell Stem Cell, highlights not only the increase and locations of these companies, but the marketing strategies used as well.

To compare the explosion in growth, the number of businesses offering unlicensed and unproven stem cell treatments in 2016 totaled 351, with only 570 clinics nationwide providing the treatment. In the first quarter of 2021, that number grew to 1,480 businesses offering unapproved stem cell products, with 2,754 clinics providing treatment.

Autologous stem cell-based products are taken from your own blood forming stem cells, and are the most common type of stem cell therapy advertised. According to Turner’s report, 45.33 percent of stem cell businesses offer autologous stem cell treatments that come from bone marrow. Additionally, 29.52 percent of the businesses offer treatments that come from adipose fat cells, and 2.83 percent of the businesses offer treatments derived from peripheral blood.

Allogeneic birth-tissue-derived stem cell products are another common treatment option offered. Around 23.64 percent of the businesses offer umbilical-cord-blood stem cell treatments. Amniotic stem cell products are offered by 17.56 percent of businesses, and 3.7 percent sell placental stem cell products. A total of 25 companies, equating to 1.68 percent, offer non-specified source allogenic stem cell products.

While most companies at least identify the source and type of the stem cell products that they offer, 14.86 percent of businesses did not identify the cell source.

Pain intervention was the biggest marketing focus, with 85.27 of businesses claiming their stem cell treatments relieved pain. The second largest target was orthopedic, with 46.55 percent of businesses claiming their products treat orthopedic conditions. Of those, 22.90 percent claimed to address sports-related injuries.

Another common target included neurology, with 9.05 percent of businesses stating they treat neurological conditions. A total of 8.24 percent of the businesses claimed their treatments worked for immunological conditions. A total of 6.4 percent claimed their products treated lung conditions, and 5.81 percent advertised their stem cells as treatment for cardiovascular disease. The businesses that advertised their stem cells as treatment for spinal cord injury or paralysis totaled 2.43 percent.

California, Florida, and Texas had the highest concentration of clinics offering unrecognized stem cell treatment, and accounted for 35.9 percent of the 2,754 clinics. While Florida has 7 million fewer residents than Texas, the state still surpassed the Texas clinic totals. The same scenario was observed for Arizona in comparison to New Jersey, with a tie for fourth largest number of clinics at 119, but the 14th most populous state.

According to Turner’s review, there is no shortage of lawsuits from adverse side effects of unapproved stem cell treatments. In closing, Turner highlights the effect these businesses have on not only patient’s health and finances, but also the medical industry as a whole with misinformation and erosion of trust. With multiple recent lawsuits and the FDA’s move to obtain a permanent injunction against companies such as US Stem Cell and Cell Surgical, he hopes it might be enough to turn the tide. Considering there are least five current lawsuits, one of which was filed earlier this month according to a Niche report, it would appear that stricter FDA regulation and oversight is inevitable.