Millions of sick Americans

need access to new therapies

that could save their lives.

Outdated FDA regulations

are standing in the way.

Help us change it

Take Action And Urge The Senate And House of Representives To Support The Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act

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Who We Are

Cell Therapy Now is a collaboration among organizations representing patients, providers, researchers, and thought leaders in the field of regenerative cell therapy.

Cell Therapy Now - Who we are

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.

Cell Therapies Are Not New

  • Safe and successful uses of human cells for therapeutic purposes have been common medical practice for more than fifty years.

  • Blood transfusions were the first type of cell therapy, and bone marrow transplantation has been the standard of care for patients with aggressive forms of cancer for decades.

  • The European Union has a regulatory exemption that allows patients to access cell therapies in hospitals under the exclusive professional responsibilities of treating physicians.

  • Many patients are forced to receive treatments overseas, and companies are taking their investments to other parts of the world, due to the FDA’s outdated regulatory framework.

Investment in the United States

  • The U.S. is falling behind other countries in advancing the science and use of cell therapies.

  • In 2014, Japan implemented a conditional approval system for cell therapies that allows a path to reimbursement while clinical trials are ongoing.

  • The European Union has a regulatory exemption that allows patients to access cell therapies in hospitals under the exclusive professional responsibilities of treating physicians.

  • Many patients are forced to receive treatments overseas, and companies are taking their investments to other parts of the world, due to the FDA’s outdated regulatory framework.

Patients Can't Wait

  • The scientific advances in cell therapy are significant and hold promise for those suffering from a multitude of conditions, including Alzheimer’s disease, cancer, and diabetes.

  • The U.S. lacks both the regulatory tools and the incentives to promote the advancement of cell therapies for Americans.

  • Patients can’t wait – Congress should support and pass the REGROW Act (S. 2689 / H.R. 4762) to bring regenerative cell therapies to the United States.