A human clinical trial is a major undertaking as the cell product needs to meet strict regulations that are defined by the Australian Government. However, for a therapy to be successful it must also comply with international government regulations so that it can be delivered to countries around the world. 

This funding from PCSRF allowed the Spinal Injury Project team at Griffith University to engage international consultants who advised them on the various international regulations and requirements. With this information, the research team was able to focus their research to generate the required data that will need to be provided in future.

Having the confidence that the cell transplantation therapy is produced in accordance with international regulations enables to team to proceed to the Phase I/IIA human clinical trial. It also will give confidence to potential investors who will be needed to support the therapy as it moves into the larger Phase IIB and Phase III trials in future.