The researchers say these businesses offer consumers unproven and unregulated stem-cell-derived treatments.
Stem cells can develop into virtually any type of cell, including heart, brain, and muscle cells. They can also recreate functioning tissue.
Over the past 20 years, stem cell therapy has gained media attention and piqued the interest of people looking for new ways to treat various health conditions. However, the only FDA-approved stem cell-based products are blood-forming stem cells used in people with conditions that disrupt the body's production of blood.
But that hasn't stopped the rise in private clinics marketing stem cell therapies to consumers. For example, a 2021 study identified 1,480 businesses operating 2,754 stem cell treatment clinics in the United States.
As a result, the FDA has issued consumer alerts warning the public that these therapies are not approved and are potentially dangerous. For example, the agency has received reports of tumor formation, blindness, and bacterial infections from these stem cell products and therapies.
Now, scientists from the University of Reading and the Universiti Sains Malaysia are calling for stricter regulation of stem cell treatments and therapies and are asking regulators to crack down on businesses that offer them.
The scientist's conclusion is based on evidence from their investigation into stem cell treatment clinics recently published in Stem Cell Research & Therapy.
The team conducted internet searches between July and November 2022 and identified 114 businesses and private clinics marketing stem cell secretome-based interventions directly to consumers — most of which were in the U.S.
Stem cells the clinics used came from varying sources such as blood, bone, or fat tissue. However, most businesses did not disclose where they obtained the stem cells.
Therapies and interventions offered were for anti-aging, hair loss, or skin care. Still, some offered services for autism, Parkinson's disease, COVID-19, and Alzheimer's disease.
Though only 38 clinics disclosed pricing on their websites, costs for services ranged from $99 to $20,000.
In addition, many businesses used weak evidence when marketing their interventions and therapies.
Although 433 clinical trials are currently registered in the ClinicalTrials.gov database, only a few are completed. Moreover, there are no standardized protocols for stem cell production, which can result in inconsistent batches delivered to consumers.
In addition, the exact actions of stem cells are not fully understood, making it challenging to determine safety and efficacy.
Therefore, the study authors say, "all direct-to-consumer businesses marketing secretome-based interventions are offering unproven therapies."
"To protect the public from health and economic risks and avoid damage to the credibility of the scientific field, new policies are needed that will translate into a tight regulatory framework that is enforced locally," the authors wrote.
They also note that educating the public about the risks associated with unproven therapies is crucial in raising awareness and reducing misinformation.
The authors add, "This should include public debates, more patient information from the regulatory bodies, and campaigns warning the public about the risks of unproven secretome-based therapies."
- NIH. Stem Cell Basics.
- Cell Stem Cell. The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions.
- FDA. Important Patient and Consumer Information About Regenerative Medicine Therapies.
- Stem Cell Research & Therapy. Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes.