ISCT, the International Society for Cell and Gene Therapy, the global professional society of clinicians, researchers, regulatory specialists, technologists and industry partners in the cell and gene therapy sector, today announces its objection to linking the benefits of cellular immunotherapy, in particular Chimeric Antigen Receptor (CAR) T-cell therapy, with recent market offerings for third party cryopreserving and banking of T-cells for future therapeutic use.
Companies around the world have launched, or may consider launching, services offering to freeze donor’s T-cells for future therapeutic use. This service is marketed to members of the public that might consider themselves potential future patients requiring chimeric antigen receptor T-cell (CAR-T) therapies. CAR-T therapies are derived from the patient’s own T-cells, the body’s immunity cells, and genetically modified to attack and destroy cancer cells whilst leaving normal cells untouched when re-administered to the patient.
ISCT, as a leading global organization representing all stakeholders across the cell and gene therapy field, has led and coordinated direct action to combat and raise awareness about unethical and unproven cell and gene therapies. This includes collaborating with more than 30 scientific societies and institutions globally. It first discussed unproven cell and gene therapies with the FDA in 2012. Direct action has ranged from establishing a multilateral task force, implementing a long term program of regulatory harmonization, to publishing a reference guide for the patient community, translated in 11 languages and authored by 23 leading figures in the field.