HELP Therapeutics Co. Ltd, a China-based clinical-stage cell therapy company, announced on Tuesday that it has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for 'Allogeneic Human iPSC-derived cardiomyocytes (HiCM-188) administered via intramyocardial injection during coronary artery bypass graft surgery'.

HiCM-188, a leading pipeline programme for HELP Therapeutics, consists of highly purified allogeneic cardiomyocytes (cardiac muscle cells) reprogrammed from human induced pluripotent stem (iPS) cells using proprietary serum-free, genetic vector-free and integration-free conditions. According to Help Therapeutics, it is the first investigational iPSC-derived cell therapy to undergo clinical assessment for the treatment of end-stage heart failure in the United States.

The Phase I study's primary objective is to assess the safety and tolerability of HiCM-188 cell transplantation one-year post-transplant. The study will evaluate various dose levels of HiCM and is expected to enrol participants at sites across the United States.

Professor Emerson C. Perin, medical director at The Texas Heart Institute, one of the planned trial centres, said: "I believe this milestone for HELP Therapeutics has the potential to advance the field of cell therapy and represents a significant step in their development programme."