Why we need you

  • Cell therapy – which involves the use of human cells to restore healthy function in the human body – represents one of the most promising areas for groundbreaking treatments.

  • Unfortunately, most patients in the U.S. lack access to life-changing cell therapies, because of the way that they are regulated by the FDA.

  • The current regulatory landscape means that cell therapies are either treated as the practice of medicine – and therefore not regulated – or as drugs, requiring a pathway lasting on average 10 years and costing more than $1 billion.

  • Fortunately, the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act of 2016 (S. 2689 / H.R. 4762) – introduced by Senators Mark Kirk (R-IL), Joe Manchin (D-WV) and Susan Collins (R-ME); and Representatives Mike Coffman (R-CO), Mark Takai (D-HI) and Morgan Griffith (R-VA) – would address this problem.

  • The REGROW Act would create a new regulatory tool for FDA, providing a middle ground for certain cell therapies that are proven safe and show signs of efficacy, as an alternative to the “all or nothing” approach that is currently in place.