From Laboratory Bench to Registration and Marketing Approval: Clinical Development for the Biomaterial Developer

In 2009 a headline announced that the FDA had approved the fi rst ever stem cell trial.

“In a move signalling the beginning of a new age in stem cell research, the Food and Drug Administration (FDA) has approved the fi rst-ever clinical trial of stem cell therapy on human subjects. The trial, funded by the biotech company Geron, will test a procedure to repair spinal cord damage”(https://www.popsci.com/scitech/article/2009-01/fda-approvesfi rst-ever-stem-cell-clinical-trial. 2012).