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receive treatments overseas, and companies are taking their investments to other parts of the world, due to the FDA’s outdated regulatory framework.