In a blog post this week Food and Drug Administration (FDA) cellular and tissue therapy chief, Steve Bauer, outlined the potential of mesenchymal stem cell, the scientific hurdles the developers and regulators face and the agency’s efforts to address them.
“Stem cells have the ability to generate more stem cells or to turn into more mature cell types such as nerve- or bone-producing cells. These properties make stem cells potentially well suited for use in regenerative medicine.”
“But there are still scientific questions to answer about MSCs. A particularly important set of questions is how the manufacturing of these cells outside of the body could affect their potential healing properties and their safety.”
To address these scientific questions the CBER has formed a seven-strong laboratory consortium to create tests and techniques to help developers improve their stem cell manufacturing processes, using cells from eight different donors.
Work ranges from the identification of 84 cell surface proteins that manufacturers can use to track the growth and differentiation of stem cells in vitro to the development of techniques capable of quantifying their ability to multiply.
The FDA scientists have also put together a database of 7753 proteins which they say “database will enhance our understanding of MSC biology and help define the variability among various MSC samples.”