HELP Therapeutics Co. Ltd, a clinical-stage cell therapy company headquartered in Nanjing, has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its allogeneic human induced pluripotent stem cell-derived cardiomyocytes (HiCM-188). This treatment involves administration via intramyocardial injection during coronary artery bypass graft surgery.
HiCM-188 marks a significant milestone as the first investigational induced pluripotent stem cell (iPSC)-derived cell therapy to enter clinical trials for the treatment of end-stage heart failure in the US. The therapy has demonstrated safety and preliminary efficacy in clinical trials conducted in China. The primary objective of the Phase I study is to assess the safety and tolerability of HiCM-188 cell transplantation at various dose levels, with a one-year post-transplant follow-up.- Flcube.com
