Help Therapeutics Co., Ltd has revealed that the China Center for Drug Evaluation (CDE) has approved the investigational new drug (IND) application of HiCM-188, a human (allogeneic) iPS cell-derived cardiomyocyte therapy in patients with worsening ischemic heart failure China CDE has approved Help Therapeutics to study the safety and efficacy of HiCM-188 implantation at various doses for clinical trials. HiCM-188, one of the leading pipeline programs of Help Therapeutics, is highly purified allogeneic cardiomyocytes (cardiac muscle cells), which are reprogrammed from human iPS cells, by using proprietary serum-free, genetic vector-free and integration-free conditions. The mechanism of action is that the transplanted cardiomyocytes electrically couple with the patient's myocardium to generate contractile force (remuscularization). Heart failure (HF) is a major public health problem, with a patient population of at least 15 million in China and approximately 65 million worldwide. Because of its age-dependent increase in incidence and prevalence, heart failure is one of the leading causes of death and hospitalization among the elderly. "In addition to ongoing clinical trials in Japan and Germany, the IND approval of Help Therapeutics' iPSC-derived product HiCM-188 is an important milestone for the treatment of heart failure by using iPSC technology", said Professor Emerson C. Perin at The Texas Heart Institute. "These cells hold tremendous promise for development in the field of iPSC-driven cardiac regeneration technology." "iPSC-cardiomyocytes might represent a useful adjunct to our current armamentarium of therapies for managing severe heart failure which, so far, has been largely restricted to experimental research and the regulatory approval of HiCM-188 is a critical step for moving this field closer to patient care", stated Professor Philippe Menasch
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