FDA issues public safety notification
Lincoln, Neb. — State health officials highlight risks related to unapproved stem cell, placental and umbilical cord blood derived products, including some that are called exosomes. According to the Nebraska Department of Health and Human Services (DHHS), some Nebraskans have become seriously ill after receiving an unapproved product.
“This isn’t unique to Nebraska. People in several other states have also experienced illness after receiving these types of unapproved products. We continue to carefully and actively assess this situation along with our federal partners,” said Dr. Maureen Tierney, Healthcare Associated Infections Lead for DHHS.
The Department issued an advisory to Nebraska health care providers alerting them to the risks associated with the unapproved products and today the FDA issued a public safety notification.
Stem cell products have the potential to treat many medical conditions and diseases. But for almost all of these products, it is not yet known whether the product has any benefit, according to the FDA. The federal agency is concerned that some patients seeking cures and remedies may resort to stem cell treatments that are potentially harmful. The FDA has the authority to regulate stem cell products in the United States. The only stem cell-based products that are FDA-approved are for limited use in patients with blood disorders or cancers. There are currently no FDA-approved exosome products.
Federal officials report that some clinics in the United States, including Nebraska, are marketing stem cell, placental and umbilical cord blood derived therapies including exosomes with claims that the treatments will improve many conditions, ranging from arthritis, injury-related pain, chronic joint pain, and anti-aging. According to the FDA, certain clinics across the country deceive patients with unsubstantiated claims about the potential for these products (exosomes) to prevent, treat or cure various diseases or conditions. These products may be administered through injection into joints or soft tissue, inhalation or intravenous injection.
Health care providers and their patients should be aware of the potential risks related to unproven stem cell treatments, placental and umbilical cord blood derived products including exosomes as noted by the FDA and Centers for Disease Control and Prevention (CDC):
- Failure of the cells to work as expected
- Injection site reaction
- Growth of tumors
- Potential for contamination of the product
- The ability of cells to move from placement sites and multiply or change into inappropriate cell types
Even if a patient’s own stem cells are being used, there are still potential risks like those mentioned above.
The CDC and the FDA offer the following advice for patients who are considering stem cell treatments:
- Check to make sure the product being considered is on the FDA’s approved list of stem cell treatments.
- If the stem cell product is not on the approved list, ask the provider to show you that they have FDA permission to research a new drug, which requires what’s called an Investigational New Drug (IND) Application number and acknowledgement communication issued by the FDA.
- Request the facts and ask questions if you don’t understand. To participate in a clinical trial that requires an IND application, you must sign a consent form that explains the experimental procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Make sure you understand the entire process and known risks before you sign. You also can ask the study sponsor for the clinical investigator’s brochure, which includes a short description of the product and information about its safety and effectiveness.
- Ask for this information before getting treatment – even if the stem cells are your own.
Because of a number of reported adverse events related to unapproved products, the FDA is increasing its oversight and enforcement to protect people, while continuing to encourage innovation so the medical industry can properly harness the potential of stem cell products.
Today’s FDA public safety notification – https://www.fda.gov/
More information from the FDA related to unapproved stem cell products – https://www.fda.gov/