Contaminated Stem Cell Products

Bacterial infections after use of stem cell products – January 28, 2019

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[Word Doc]

Warning about Unproven Stem Cell Therapies

Patients should understand the risks before considering procedures involving unproven and unapproved stem cell therapies. Some clinics in the United States are marketing stem cell therapies with claims that the cells will treat many conditions, ranging from normal aging to chronic pain.

The use of umbilical cord blood-derived stem cells to treat these types of conditions is not approved by the Food and Drug Administration (FDA) unless the stem cell product is part of a clinical trial and is being studied under an Investigational New Drug Application (IND), which is a clinical investigation plan submitted and allowed to proceed by the FDA. (Learn more on the FDA’s clinical trials pageexternal icon)

While all medical treatments have benefits and risks, unapproved stem cell therapies have the potential to expose patients to risks without a clear benefit. Stem cell products have the potential to treat many medical conditions and diseases, but for almost all of these products, further research is needed to know whether the product has any benefit or if it is 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)

What Patients Need to Know

Currently, the only stem cell treatments approved by the 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 are not approved by FDA unless they are part of a study under an IND.

The FDA has the authority to regulate stem cell products in the United States. Some clinics may advertise stem cell clinical trials that do not have FDA approval, while some may falsely advertise that it is not necessary for FDA to review and approve stem cell therapy.

The Risks

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
  • Infections
  • Potential for contamination of the product
  • The ability of cells to move from placement sites and multiply or change into inappropriate cell types
What Patients can do to Protect Themselves

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, ask the provider to show you that they have FDA permission to research a new drug, which requires an IND application number and acknowledgment communication issued by FDA. Ask for this information before getting treatment—even if the stem cells 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 therapy should discuss any concerns and abnormal reactions with their healthcare provider. Patients who received stem cell products from ReGen Series® (distributed by Liveyon, LLC) should discuss with their healthcare provider if they should be evaluated for HIV, hepatitis B virus, hepatitis C virus, or other infections.

Frequently Asked Questions

What is the rationale for notifying all clinics and providers that have ever received the ReGen Series® product about the risk of bloodborne pathogens?

The ReGen Series® product was processed by Genetech and distributed by Liveyon. The U.S. Food & Drug Administration (FDA) issued a warning letter to Genetech in November 2018

(https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm628019.htmexternal icon)

following an inspection of the firm. During the inspection, FDA identified serious deficiencies in Genetech’s manufacture of the product, including deficient donor testing and screening procedures. Because of these deficiencies in donor screening identified by FDA, all products during the period of processing by Genetech have potential for contamination.

 

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.

 

Why should patients be notified now if the ReGen Series® product was recalled months ago?

Liveyon recalled the ReGen Series® product on September 28, 2018, due to the concerns for bacterial contamination. Due to the amount of time that has passed, it is unlikely that patients are still at risk of bacterial infections following exposure to the recalled product. In addition to concerns about bacterial infections, on December 20, 2018, FDA posted the warning letter issued to Genetech outlining the donor testing and screening deficiencies that might have put patients who received the product at risk for exposure to communicable diseases such as HIV, hepatitis B, or hepatitis C. Patients with these infections might not have symptoms and require testing for diagnosis. If HIV, hepatitis B, or hepatitis C infection is detected, treatment options are available.

 

Is there a risk for developing a bacterial infection from umbilical cord blood-derived stem cell products other than Liveyon’s ReGen Series® product?

Patients should understand the risks before considering unproven and unapproved stem cell therapies. Some clinics in the United States are marketing stem cell therapies with claims that the products will treat many conditions, ranging from normal aging to chronic pain. The use of umbilical cord blood-derived stem cell products to treat these types of conditions is not approved by FDA.

While all medical treatments have benefits and risks, unapproved stem cell therapies have the potential to expose patients to risks without a clear benefit.

Further information is available at: https://www.cdc.gov/hai/outbreaks/stem-cell-products.html.

 

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 ocod@fda.hhs.gov.

More information about FDA’s regulatory framework is available here:

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm585345.htmexternal icon