Stem Cell and Exosome Products
Warning about unapproved therapies
While all medical treatments have benefits and risks, unapproved stem cell and exosome products expose patients to potential risks without a clear benefit. These products may have the potential to treat many medical conditions and diseases, but further research is needed to know whether the products have any benefit or whether they are safe to use. Be sure to get all of the facts if you are considering any stem cell treatment. (Read FDA’s warning about stem cell therapiesexternal icon)
Currently, the only stem cell treatments approved by the Food and Drug Administration (FDA) are products that treat certain cancers and disorders of the blood and immune system. If the products are being used for arthritis, injury-related pain, chronic joint pain, anti-aging or other health issues, they have not been approved by FDA and are being marketed illegally. The FDA has not approved any exosome products for any uses.
The FDA regulates stem cell and exosome products in the United States. Some clinics may falsely advertise that it is not necessary for FDA to review and approve their stem cell therapies. They may claim that their registration with FDA or an FDA inspection equates to FDA approval or a form of FDA endorsement. These claims are false.
Clinics often advertise that they are conducting clinical trials using these products. Patients should ask clinics for documentation from FDA that they are conducting a clinical trial under an active investigational new drug application, also known as an IND. Patients should always be wary if a clinic advertises a patient-funded clinical trial.
Patients should be aware of potential risks related to unproven stem cell treatments:
- Injection site reaction
- Failure of the cells to work as expected
- 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
Patients should also be aware of potential risks of exosomes. Recently, patients in Nebraska who where treated with products marketed as containing exosomes experienced serious adverse events, including bacterial infections.
There are no FDA-approved exosome products. If you are considering stem cell treatments, check to make sure the product you are considering is on the FDA’s approved list of stem cell treatmentsexternal icon. If the stem cell product is not on the approved list or if you are considering an exosome product, ask the provider to show you documentation from the FDA and that they have FDA’s permission to research the product. This documentation would include an IND application number and acknowledgment communication issued by FDA. Ask for this information before getting treatment—even if the stem cells or exosomes are your own.
If you are considering participating in a clinical trial, check the FDA’s clinical trial pageexternal icon. 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.
Patients who have had stem cell or exosome therapy should discuss any concerns and abnormal reactions with their healthcare provider.
CDC is investigating bacterial infections in patients who have received stem cell products from the ReGen Series® (distributed by Liveyon, LLC). Most of these patients developed symptoms such as pain, swelling, or chills within a few days of receiving the stem cell products. Liveyon, LLC, recalled these products on September 28, 2018.
A Food and Drug Administration (FDA) inspection of Genetech, the company that processed these products (which is not related to the biotechnology firm Genentech), found problems with the manufacturing process. FDA also found that the facility did not determine if donors of the umbilical cord blood used to make these products were eligible by appropriately screening them for diseases such as human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
CDC is not currently aware of any HIV, hepatitis B, or hepatitis C infections linked to the ReGen Series® products, and transmission risk is very low. However, as a precaution, we recommend that patients talk to their healthcare provider about getting tested for HIV, hepatitis B virus, and hepatitis C virus. There are treatment options for patients who undergo testing and test positive for any of these three infections. Patients should discuss with their healthcare provider if they should be evaluated for bacterial infection or communicable diseases other than HIV, hepatitis B virus, or hepatitis C virus.
Information for Healthcare Providers: Stem Cell Provider Letter word icon[DOCX – 1 page]
Should all patients who received the ReGen Series® product be tested for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C?
Healthcare providers should discuss testing with their patients on a case-by-case basis. To date, there have not been any reports of HIV, hepatitis B, and hepatitis C transmission associated with these products. If any of these infections are detected, treatment options are available.
Have any HIV, hepatitis B virus, or hepatitis C virus infections been found to be associated with the use of these products?
No. To date, there have not been any HIV, hepatitis B or hepatitis C infections reported following use of these products. The only infections associated with the use of Liveyon’s ReGen Series® product have been bacterial infections, for example, infections with E. coli, Enterobacter cloacae, and Enterococcus faecalis.
How high is the risk for transmission of bloodborne pathogens from the ReGen Series® product?
The risk of transmission of bloodborne pathogens is likely very low. CDC is not currently aware of any HIV, hepatitis B, or hepatitis C infections linked to the ReGen Series® products.
Are there recommendations regarding the type of screening tests to use?
Healthcare providers can refer to CDC’s web page for information on testing for HIV, hepatitis B, and hepatitis C: https://www.cdc.gov/hepatitis/outbreaks/toolkit.htm. Testing for other communicable diseases should be determined on a case-by-case basis.
Does FDA regulate these products?
FDA has had regulations for these types of products since 2005. Additionally, FDA announced its comprehensive policy framework for human cells, tissues and cellular and tissue-based products in 2017. FDA has stated that until November 2020, the agency will focus compliance and enforcement actions on certain products that are likely to raise reported safety concerns or potential significant safety concerns.
Where can providers go for more information about FDA regulation of stem cell products?
Providers with questions can contact FDA’s Center for Biologics Evaluation and Research (CBER) Office of Communications, Outreach and Development at firstname.lastname@example.org.
More information about FDA’s regulatory framework is available here:
FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at riskexternal icon
FDA’s Public Safety Notification on Exosome Productsexternal icon
FDA Sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk.external icon
CDC Notes from the field: Infections After Receipt of Bacterially Contaminated Umbilical Cord Blood-Derived Stem Cell Products.
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.external icon
FDA’s letter reiterate compliance and enforcement policy to other manufacturers and health care providers who may be offering stem cell treatments. pdf icon[PDF – 95.2 KB]external icon