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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 Doc]

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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 page)

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 therapies)

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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.

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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

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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 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 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 page. 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.

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