Definitions

Definition of Advanced Cell Therapy Trials:

We define Advanced Cell Therapy as all therapies in which cells are more than minimally manipulated, and/or their action is not homologous.

Our definition is similar to the European Medicines Agency (EMA) definition of Advanced Therapy Medicinal Product (ATMP): “Medicinal product for human use that is a gene therapy medicinal product, a somatic cell therapy medicinal product or tissue engineered product” (EMA ATMP Reg. No. 1394/2007)

The definition of Advanced Cell Therapy overlaps with, but is not the same as, Regenerative Medicine, which is defined as therapy that "replaces or regenerates human cells, tissue or organs, to restore or establish normal function" (Mason & Dunnil 2008)

Advanced Cell Therapy encompasses Regenerative Medicine with cells, and in addition includes Cellular Immunotherapy, Gene Therapy that is delivered by cells, and Tissue Engineering that is seeded or administered with cells.

Note that Advanced Cell Therapy does not include Hematopoietic Stem Cell Transplants (HSCT), unless the cells are more than minimally manipulated before they are administered. Advanced Cell Therapy does not include Gene Therapy or Tissue Engineering that does not employ cells.

Please bear in mind that the other compilations in our comparison table each have their own selection criteria for compiling trials.