Editor’s Note: Hans Keirstead has started six high-tech health companies, including Aivita Biomedical to develop stem cell applications and Immunis Inc. to help people improve their immunity with a booster shot.
This year, he was appointed CEO of the Human Immunome Project, a global initiative that combines biomedicine and artificial intelligence to get a more sophisticated understanding of human immunity and disease. In 2022, he won a Business Journal Innovator of the Year Award.
The stem cell industry is experiencing a resurgence of late, as evidenced by the increasing number of commercial entities, clinical trials and publications, while the market value and public interest has never been higher.
As a longtime entrepreneur and professor in this sector, I receive countless queries about what is real and what is not, where the money should go and where it should not, who is the chaperone and who is the charlatan.
Stem cells deserve your serious attention. They are the building blocks that make you, so undoubtedly have the potential to help therapeutic development for every disease and injury.
They can make themselves and every cell in your body. They are a renewable source of replacement cells for those lost to disease or injury, models of human development and disease, a surrogate for humans on which to test drugs, a means to deliver new genes or drugs or growth factors, and they play several roles in the regeneration of damaged tissues.
But stem cells are also one of the most successful and abused marketing campaigns in biotechnology, one that is robbing millions of people of their hard-earned money, starving real science and medicine by diverting investment dollars to the make-believe, and creating false hope for patients with real hardship.
Since 2018, the Food and Drug Administration has issued over 3,000 warning letters to companies, many of them instructing stem cell clinics in the USA to cease and desist. But these threats are not followed by arrests or chained door fronts, as the FDA commands no enforcement agency.
As a result, these putative stem cell clinics continue to offer treatments that have never been validated for safety or efficacy, demanding a high price for unapproved treatments on the unsubstantiated promise of a cure for everything from Alzheimer’s disease and aging, to joint pain and wrinkled skin.
These promises are not just a sin of spinning false hope; they are also a sin of selling true risk for a quick buck.
The primary reason for an unsubstantiated clinic to avoid the FDA is an uncontrollable manufacturing process.
In the case of stem cells, an uncontrollable manufacturing process can lead to tumor formation, infection, blood clots, or adverse immune reactions. Equally concerning is the supply chain used by uncredentialed clinics, where the abuse or disease of the donor are not assessed or reported.
By my estimation, about 1 in 10 stem cell purveyors are real.
The genuine players in the stem cell sector offer tremendous promise for multiple diseases, injuries and health concerns.
Just last year, a California bond initiative provided $5.5 billion to the California Institute of Regenerative Medicine, the world’s best funded agency supporting stem cell research. Stem cells are routinely used in conventional drug discovery as surrogates to human tissues.
They have been used successfully for the treatment of leukemia for well over a decade.
Clinical trials have shown promise for the treatment of immune disorders, joint pain, graft rejection, several blood-born cancers, retinal disease, Type 1 diabetes, and brain cancer.
Right here in Orange Country, jCell has shown promise in the application of stem cell technologies to retinal disease, Aivita Biomedical has shown promise in the application of stem cell technologies to glioblastoma and melanoma and is now approved for Phase 3 studies, and Immunis has shown promise in the application of stem cell technologies to multiple manifestations of age-related immune decline, making use of an exciting new FDA-approved drug category called the secretome.
A secretome is comprised of growth and regenerative factors that are produced by stem cells, so the patient receives only the secreted protein set rather than cells, making for a safer, more effective, and cheaper therapy.
The stem cell sector offers real therapies and limitless potential, but it is not immune to bogus claims and misleading advertisements. Thus, it is crucial for patients to be well-informed and exercise caution when considering stem cell treatments.
Consulting with healthcare professionals, understanding the evidence behind a specific treatment, and considering the regulatory status of the therapy are all essential steps to ensure one’s safety and the most successful outcome.
If you are considering treatment by a stem cell clinic without FDA approval, consider why that clinic avoided the FDA when FDA-approved drugs enjoy a market size that is exponentially larger than drugs without FDA approval.
Type the name of the clinic or doctor into a search engine along with the words “FDA warning letter” to determine if they were issued a cease-and-desist order by the FDA.
These steps may save you money and protect you from harm, and better equip you to sort the chaperones from the charlatans.
