Abstract
It is an exciting time for cellular and genetic therapies. Since 1989 over 1500 Phase I/II studies of direct in vivo and cell-mediated gene therapy in diverse diseases have been completed. 1 Substantial evidence of improved clinical outcomes has been shown in haemophilia B, immune deficiencies, haemoglobinopathies, immunotherapies and blindness. In the field of cellular therapeutics, applications have expanded beyond the foundation in autologous and allogeneic haemopoietic cell transplantation to mesenchymal and other adult cell therapy trials. Indeed, if plur-ipotent cells can be differentiated ex vivo to recreate and repair mature human tissues and organs, then regenerative medicine will become a reality. However, embryonic stem cells have been mired in controversy and clinical development has been forestalled. 2 Almost every country in the Asia-Pacific region offers at least some cellular therapy options, from ‘highly regulated’ countries like Singapore, Japan, Korea and Australia, through to countries where the oversight is less formal. Medical and, in particular, stem cell tourism has become a billion dollar industry with increasing examples of false claims. 3 Unregulated, untested or unsafe stem cell ‘therapies’ place the field at a challenging crossroad.
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