Maintaining Quality in Stem Cell Products: Recent Developments in Regulation (Series Part 1 of 4)

Background

Stem cells are naturally occurring cells in the body that have the ability to divide and produce a range of different cell types. They are important in the growth and development of the body as well as repair after injury. The past few years have brought a dramatic increase in the body of knowledge concerning stem cells, and their research and investment into uses in medicines¹.

Recent Regulation

The FDA has issued recent regulation on stem cell products in the following ways:

• Published their perspective on stem cell therapy in the New England Journal of Medicine
• Increased regulation enforcement for stem cell clinics
• Released new guidance, Regulatory Consideration for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

The EMA released their guidance on human cell-based medicinal products already in 2006, with genetically modified medicinal product regulation in 2008, and a reflection on stem cell-based medicinal products in 2011. These published works are intended for pushing innovation, safety, and efficacy for stem cell therapies.

Lapse in Quality

In early 2019, the Centers for Disease Control and Prevention (CDC) reported bacterial infections after use of stem cell products², 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.

Looking to the Future

Stem cell therapy manufacture is a growing industry with the potential to better quality of life for those who suffer from currently incurable diseases. Regulation of this sector will continue to grow as time passes, and it is imperative that manufacturers are ready for the enforcement of higher standards.