Cell therapy is governed by the FDA office CBER. Human trials that involve regenerative medicine include quite fewer human subjects than regular drugs, keeping overall clinical trial costs down. SMSbiotech intends to request a fast-track designation during the IND submission, given the therapy addresses a serious disease. Based on the 21st Century Act passed by Congress, SMSbiotech regenerative therapy qualifies for RMAT (Regenerative Medicine Advanced Therapy) designation. This, however, requires completing some human testing. RMAT includes all breakthrough therapy designation features, including early interactions with FDA, and it supports accelerated approval. Furthermore, based on the severity of the disease and the absence of solutions, FDA will grant expanded access (compassionate use). This will allow for a revenue-generating implementation of the therapy during the early trial period as well as the targeting of other indications.