As of mid-year 2018, there were more than 950 regenerative medicine therapies in clinical trials, of which more than 90 are in Phase III. In addition, according to the MIT NEWDIGS consortium FoCUS Project (Financing and Reimbursement of Cures in the US), approximately 39 gene therapies will be approved by the end of 2022. Product candidates in development address diseases involving almost every major organ system, from ultra-orphan neurodegenerative diseases like adrenoleukodystrophy, to highly prevalent public health concerns such as several forms of cancer, congestive heart failure and diabetes, ailments that affect tens of millions of patients worldwide.
The US FDA has recognized the need to accelerate regenerative therapies. In November 2017, FDA Commissioner Scott Gottlieb noted the “transformative promise” of these technologies and said this potential is...
