The CDC is investigating bacterial infections in patients who received stem cell treatments from the ReGen Series, distributed by Liveyon.
Five things to know:
1. Most of the affected patients developed symptoms such as pain, swelling or chills within several days of receiving the stem cell products. Liveyon recalled the products Sept. 28, 2018.
2. When the FDA inspected Genetech, which processed the stem cell products, it found problems with the manufacturing process.
3. The FDA found the Genetech facility did not determine if donors of the umbilical cord blood used to in these products were eligible by appropriately screening them for diseases, including HIV, hepatitis B and hepatitis C.
4. At present, the CDC is not aware of any HIV, hepatitis B or hepatitis C infections linked to the ReGen Series products.
5. Transmission risk is very low, but the CDC recommends affected patients talk to their healthcare provider about getting tested for HIV, hepatitis B and hepatitis C as a precaution.