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healthcare-associated infections (HAI) program

Infections Associated with Umbilical Cord Blood Stem Cell Products

The California Department of Public Health (CDPH) Healthcare Associated Infections (HAI) Program, in collaboration with local public health officials, is warning providers and patients about serious bacterial infections following injections with umbilical cord blood stem cell products that are being used for treatments not approved by the U.S. Food and Drug Administration (FDA). 

What are umbilical cord blood stem cells?

Stem cells are cells with the ability to divide for indefinite periods and give rise to specialized cells. Stem cells collected from the umbilical cord at birth can produce all red and white blood cells and platelets in the body. The body’s blood producing system is called the hematopoietic system.


What are the FDA-approved indications for injection of umbilical cord blood stem cells?

FDA-approves umbilical cord blood stem cells to reconstitute (restore) hematopoietic and immunologic function in patients with disorders of the hematopoietic (blood producing) system.  Such disorders may be inherited, acquired, or result from treatments that kill the cells in the hematopoietic system. 
 

Can umbilical cord blood stem cells be used to treat chronic pain associated with orthopedic conditions or aging-associated conditions?

The safety and effectiveness of stem cells to treat conditions such as chronic pain associated with orthopedic conditions and aging-related conditions have not been established.  Use of stem cells for these indications is NOT approved by the FDA unless an investigational new drug application (IND) is in effect. 

California law (Business and Professions Code Section 684) requires that clinicians post a notice in a prominent location in their offices to inform patients if they are performing non-FDA approved stem cell therapies.

How does the FDA ensure approved umbilical cord blood stem cells products are safe?

FDA requires that umbilical cord blood stem cells are manufactured, transported, processed, and stored under well-defined conditions of temperature and sterility to prevent distribution of product contaminated with bacteria.  Donors must be screened and umbilical cord blood tested using FDA-approved tests to assure that infectious agents are not transmitted to recipients.

 

What happens when umbilical cord blood stem cell products are unsafe or used without FDA approval?

Serious bacterial infections of the bloodstream, joints, and spine have occurred following injection of non-FDA approved umbilical cord blood stem cells. Tumors have formed in the organ where stem cells were injected.  Injection into the eye has caused blindness.

In 2018, the U.S. Centers for Disease Control (CDC) identified multiple infections that occurred after injection with a specific stem cell product, the ReGen Series,® manufactured by Genetech (not related to the biotechnology firm Genentech) and distributed by Liveyon LLC.  Both companies are in California.

CDPH is also aware of bacterial infections that occurred following injections with other non-FDA approved stem cell products. 

 

What is CDPH doing to inform providers and alert patients of the infection risk associated with non-FDA approved use of these products?

In March 2019, the CDPH HAI program is sending letters to providers who purchased and may have treated patients with the Genetech ReGen Series.® 

  • The letter instructs providers to notify their patients who received the ReGen Series product by sending a CDPH Notice to Patients
  • The CDPH Notice informs patients of safety concerns with the ReGen Series® stem cell product, as well as similar non-FDA approved stem cell products. 
  • Patients should report any diagnosis of infection after stem cell injection or infusion to their local health department or HAIProgram@cdph.ca.gov.

 

Why does the CDPH Notice to Patients recommend that patients discuss bloodborne pathogen testing with their primary healthcare providers?  

Upon inspection of Genetech, FDA found a number of manufacturing deficiencies, including failure to appropriately screen stem cell donors for bloodborne pathogens, such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV). 

  • To date, no HIV, HBV, or HCV infections been reported after ReGen Series® stem cell injections.
  • Although the risk of transmission of HIV, HBV, and HCV is very low, CDPH recommends that patients who received stem cell injections with the ReGen Series® product talk with their primary care providers about the need to be tested. 
  • The rare patient who might have developed a bloodborne infection will benefit from being diagnosed because there are effective treatments for each of these infections.

 

Where can I find more information?

 

For additional questions, contact HAIProgram@cdph.ca.gov

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