CDC investigates contaminated stem cell products: 5 things to know

Written by Shayna Korol | January 31, 2019 | Print  |

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.

More articles on biologics:
Global spine biologics market to hit $2.7B by 2024 — 18 key players
U of Missouri to release biojoint records amid allegations of false marketing: 5 things to know
Japan approves stem cell treatment for SCI — Some researchers doubt efficacy

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies here.

Top 40 Articles from the Past 6 Months