Oct. 7 (UPI) — Twenty people who used umbilical cord blood-derived products marketed as stem cell therapies at clinics across the United States developed serious bacterial infections, a report published Thursday by JAMA Network Open found.
Those with infections received Liveyon-branded products between August 2017 and September 2018 at clinics in Texas, Florida, California, Arizona, Kansas, Maine, Colorado and Massachusetts, the data showed.
The treatments were used to treat pain caused by injuries, as well as osteoarthritis and rheumatoid arthritis, the researchers said.
Ten users of these therapies developed infections at the injection site, such as septic arthritis of the injected joint or epidural abscesses, but five suffered bloodstream infections and five had both, they said.
All but one of the 20 infection cases required hospital treatment, with some hospitalized for nearly two months.
Liveyon, which has since recalled the products used with patients included in the study, has not responded to several requests for comment by UPI.
Clinics touting unproven stem-cell procedures received a reprieve from the Food and Drug Administration in 2017, when they were granted three years to demonstrate that their treatments were safe and effective before regulators would step in.
However, when that grace period expired in late May — after a COVID-19 pandemic-related six-month extension — the market had expanded, with hundreds more clinics selling the treatments for arthritis, Alzheimer’s and COVID-19, among other conditions.
Currently, umbilical cord-derived stem cell therapies have been approved by the FDA only for use in people with blood disorders, such as blood clots.
“The findings of this investigation show that stem cell therapies that are not FDA-approved or that are not used for approved or proven medical conditions can pose serious health risks to patients with no benefit,” study co-author Dr. Kiran Mayi Perkins told UPI in an email.
“These products are often illegally marketed by clinics as being safe and effective for treating a wide range of diseases or conditions,” said Perkins, a researcher with the Centers for Disease Control and Prevention.
The FDA has warned against the use of these products until they have been evaluated and approved.
However, since the expiration of the grace period in May, the agency has not indicated how it plans to deal with the clinics offering these treatments, which can cost as much as $5,000, according to reports.
In a press release, the FDA said it expects companies developing these therapies to submit clinical trial data demonstrating their safety and effectiveness, similar to the approval process for prescription drugs.
It is unclear how many, if any, have initiated this process, which can cost millions of dollars.
For this report, Perkins and her colleagues documented 20 cases of bacterial infection that developed in patients who received stem cell therapies from for-profit clinics over a roughly one-year period.
In most cases, treatments were administered via injections into patients’ knees, shoulders, spine, or fingers and toes, although two patients received intravenous infusion and one was given a nasal spray.
Fourteen of the patients had Escherichia coli, or E. coli, infections and seven had infections caused by Enterobacter cloacae bacteria, the data showed.
In addition, the team tested 34 unopened vials of umbilical cord-derived stem cell therapies and found that 22 were contaminated with at least one of 16 bacterial species.
Liveyon voluntarily recalled the affected stem cell products in 2018, which were processed by the company Genetech, according to the FDA.
“Patients should be aware of the unproven benefits and the potential risks to their health when using unapproved and unproven stem cell products for conditions that they have not been shown to effectively treat,” Perkins said.
“These infections demonstrate that clinics and manufacturers continue to illegally market these products to consumers and their use can potentially pose serious risks, such as infections, to patients,” she said.