Sterility Assurance Applied to Stem Cell Therapies

In early 2019, the Centers for Disease Control and Prevention (CDC) reported bacterial infections after use of stem cell products and are currently investigating the ReGen Series.

The FDA inspection of the ReGen product manufacturer found problems with its process, including that the facility had not screened the umbilical cord blood donors for diseases such as HIV, hepatitis B, and hepatitis C.

Patients reported symptoms of pain, swelling and chills within a few days of receiving the stem cell product, which was later recalled.

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