CellPro must amend Ceprate stem cell premarket approval (PMA):
This article was originally published in Clinica
Executive Summary
The US FDA has told CellPro (US) it must amend the PMA for its stem cell concentration system, Ceprate-SC, before it can be approved. Among the issues raised by the FDA are additional studies on engraftment and patient survival. CellPro says that ongoing and recently-completed trials may provide some of the data.