Stem cell therapy has immense potential to relieve human suffering and give solutions to medical issues that are now unfulfilled. Stem cells must follow the same regulatory procedure as drugs to reach the clinic. Investigator-initiated methods frequently use stem cells as pharmaceuticals; therefore investigators must be aware of these regulatory mechanisms from the beginning of the translational process. Furthermore, because of the highly complicated nature of cells as pharmaceuticals, the translational pathway to development will necessitate specific considerations.