According to a study published Thursday in the journal Cell Stem Cell, nearly 2,800 clinics operated by nearly 1,500 companies are selling unapproved stem cell therapies that lack clinical evidence of effectiveness and safety.
Unlicensed stem cell therapy business is growing. Leigh Turner, a professor at the University of California, Irvine, said that as of March, the number of companies and clinics providing these treatments was more than four times the number in 2016. The research author. The study determined that 1,480 companies have 2,754 clinics selling these stem cell therapies.
Despite the Food and Drug Administration’s efforts to enforce stem cell regulations and enable suppliers to comply with regulations, the market for stem cell therapy that has not been approved by the FDA has Dramatic increase, Turner said.
“We have created an economic environment in which there are many reasons not to follow the compliance route, because developing safe and effective products is really challenging,” Turner said. “This is a market that companies can enter immediately, without any clinical research or compliance with federal regulations, but they can make money immediately.
FDA approved 22 Cell and gene therapy, Mainly used to treat cancer and other rare and life-threatening diseases.
The agency is also trying to control unlicensed stem cell treatments through law enforcement actions, such as warning letters and other communications with suppliers. The FDA and the Department of Justice have also obtained permanent injunctions against some companies.
Turner said that the growth of this market will only expose the FDA, states, and medical commissions to more severe regulatory challenges, which means a more rigorous approach is required. “It’s encouraging to see the response from regulators, but I think the market itself is surpassing that response,” he said.
Studies have found that companies that provide unapproved therapies market them as treatments for various diseases and injuries without first conducting proper clinical trials.
California has the highest concentration of clinics selling unlicensed treatments, with 347 clinics, followed by Florida with 333, and Texas with 310. More than one-third of the clinics that perform these stem cell therapies are located in these three states.
Turner said that some clinics are units of listed companies, and many clinics are operated by academic institutions and university health systems.
The study found that although 22.9% of these companies claim to be stem cell clinics or stem cell and regenerative medicine suppliers, other companies focus on pain relief, orthopedic care, comprehensive medicine, chiropractic, sports medicine, health and cosmetic surgery, etc. field. 85.3% of people touted their treatments for pain, orthopedic diseases or injuries.
The form of autologous stem cell products is the most frequently advertised intervention, with 671 companies selling bone marrow stem cell therapy and 437 selling adipose stem cell therapy. 40% of these suppliers sell mesenchymal stem cell treatments, and many suppliers provide allogeneic birth tissue-derived stem cell products from umbilical cord blood or tissue, amniotic stem cells or placental stem cells. 14.9% of stem cell clinics did not specify the cell source or cell type they used.
Turner said that in addition to questions about the safety and effectiveness of these therapies, their increasing availability hinders medical research that can provide clinical evidence because they reduce the number of potential research subjects.
“Instead of providing well-designed clinical trial facilities, people might as well spend $5,000 or $10,000 to go to the clinic, where they can immediately get any content in the ad,” Turner said. “And they don’t have to worry about participating in clinical trials, random assignment or taking placebos.”
Paul Keckley, executive editor of the Keckley report and health policy consultant, said that while this may be beneficial, participating in stem cell therapies that have not been approved by the FDA or supported by important scientific evidence is risky.
Keckley said that many patients seeking alternative treatments cannot obtain accurate and reliable information about their condition online because commercial sources have their own biases, and even the medical profession sometimes disagrees.
Keckley said: “In the United States, we did not invest a lot of money to let individuals know the evidence and obtain evidence more widely, which is almost an embarrassment.”