Media Mention

Mary Sylvia Discusses Recent Appeals Court Ruling on Stem Cells

BioWorld Today
February 18, 2014

Mary Sylvia, a partner in Wiley Rein’s Intellectual Property Practice, was quoted in a February 7 BioWorld Today article about a recent U.S. Court of Appeals for the District of Columbia Circuit ruling on a stem cell product.

In a February 4 ruling, the court found that Regenexx-C, a stem cell product, is subject to labeling and regulation by the U.S. Food and Drug Administration (FDA).  In concurring with arguments made by the government, the court found that culturing mesenchymal stem cells (MSCs) changes the stem cells’ biological characteristics enough to exceed the FDA’s “minimal manipulation” threshold, thereby subjecting it to regulation, according to the article.  The ruling upholds an FDA injunction filed against Regenexx-C’s manufacturer, Regenerative Sciences, in 2010.

“Even in autologous uses, removing cells and culturing them entails the addition of many externals … that deserves oversight,” Ms. Sylvia told BioWorld Today.

Read Time: 1 min

Related Professionals

Practice Areas

Contact

Maria Woehr Aronson
Director of Communications
202.719.3132
maronson@wiley.law 

Molly Peterson
Senior Communications Manager
202.719.3109
mmpeterson@wiley.law

Jump to top of page

Necessary Cookies

Necessary cookies enable core functionality such as security, network management, and accessibility. You may disable these by changing your browser settings, but this may affect how the website functions.

Analytical Cookies

Analytical cookies help us improve our website by collecting and reporting information on its usage. We access and process information from these cookies at an aggregate level.