{"id":9533,"date":"2024-10-25T13:21:52","date_gmt":"2024-10-25T05:21:52","guid":{"rendered":"https:\/\/flcube.com\/?p=9533"},"modified":"2024-10-25T13:21:56","modified_gmt":"2024-10-25T05:21:56","slug":"help-therapeutics-receives-fda-clearance-for-phase-i-clinical-trial-of-hicm-188-cell-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=9533","title":{"rendered":"HELP Therapeutics Receives FDA Clearance for Phase I Clinical Trial of HiCM-188 Cell Therapy"},"content":{"rendered":"\n<p>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.<\/p>\n\n\n\n<p>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.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>HELP Therapeutics Co. Ltd, a clinical-stage cell therapy company headquartered in Nanjing, has announced that&#8230;<\/p>\n","protected":false},"author":1,"featured_media":9534,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,10],"tags":[30,1595],"class_list":["post-9533","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-deals","tag-biotech","tag-help-therapeutics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>HELP Therapeutics Receives FDA Clearance for Phase I Clinical Trial of HiCM-188 Cell Therapy - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"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.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=9533\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"HELP Therapeutics Receives FDA Clearance for Phase I Clinical Trial of HiCM-188 Cell Therapy\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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