{"id":44601,"date":"2022-06-02T06:01:54","date_gmt":"2022-06-02T04:01:54","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/megakaryon-corporation-initiates-first-in-human-clinical-trial-of-allogenic-human-ipsc-derived-hla-homozygous-platelets-meg-002\/"},"modified":"2022-06-02T06:01:54","modified_gmt":"2022-06-02T04:01:54","slug":"megakaryon-corporation-initiates-first-in-human-clinical-trial-of-allogenic-human-ipsc-derived-hla-homozygous-platelets-meg-002","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/megakaryon-corporation-initiates-first-in-human-clinical-trial-of-allogenic-human-ipsc-derived-hla-homozygous-platelets-meg-002\/","title":{"rendered":"Megakaryon Corporation Initiates First-in-Human Clinical Trial of Allogenic Human iPSC-Derived HLA Homozygous Platelets (MEG-002)"},"content":{"rendered":"
\n

KYOTO, Japan–(BUSINESS WIRE)–Megakaryon Corporation (hereinafter, Megakaryon) today announces its clinical trial of allogenic human iPSC-derived HLA homozygous platelets (Development Code: MEG-002) in collaboration with Kyoto University Hospital, Center for iPS Cell Research and Application, Kyoto University (CiRA) and CiRA Foundation (CiRA_F).
\n
Initial administration to the first subject was successful and with no reported adverse events.\n<\/p>\n

<\/a><\/p>\n

\nBackground<\/b>\n<\/p>\n

\nThe Department of Hematology, Kyoto University Hospital (Professor Akifumi Takaori-Kondo, M.D., Ph.D.) and CiRA (Professor Koji Eto M.D., Ph.D.) have conducted clinical research for the transfer of autologous iPSC-derived platelets to a thrombocytopenia patient to verify the safety of iPSC-derived platelet preparations. The clinical trial announced today is for a study using allogenic human iPSC-derived HLA homozygous platelets developed by Megakaryon which will enable industrialization of iPSC-derived platelets and their subsequent availability to a large number of patients.\n<\/p>\n

\nAbout the first administration of investigational product<\/b>\n<\/p>\n\n\n\n\n\n\n\n\n
\n

\nHospital:\n<\/p>\n<\/td>\n

\n

\nKyoto University Hospital\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nDosing date:\n<\/p>\n<\/td>\n

\n

\nApril 2022\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nCoordinating investigator:\n<\/p>\n<\/td>\n

\n

\nAkifumi Takaori-Kondo, M.D., Ph.D., Professor of Hematology and Oncology\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPrincipal investigator:\n<\/p>\n<\/td>\n

\n

\nJunya Kanda, M.D., Ph.D., Associate Professor of Hematology and Oncology\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nClinical trial products:\n<\/p>\n<\/td>\n

\n

\nAllogenic human iPSC-derived HLA homozygous platelets (MEG-002)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nDose:\n<\/p>\n<\/td>\n

\n

\n3 units (0.6×10^11<\/sup> platelets)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nManufacturing location:\n<\/p>\n<\/td>\n

\n

\nFacility for iPS Cell Therapy (FiT) of CiRA_F\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nSummary of the clinical trial<\/b>\n<\/p>\n

\nDuring the clinical trial, Megakaryon will assess the safety and estimate the efficacy of MEG-002 for patients with thrombocytopenia. MEG-002 is prepared from an iPSC provided by CiRA (currently CiRA_F) and consists of platelets with the most common HLA haplotype among the Japanese population. The technology for producing platelets from iPSCs invented by Professor Koji Eto is used for the development of MEG-002. The clinical trial will be conducted at multiple medical institutions, including the Department of Hematology and Oncology, Kyoto University Hospital using a product manufactured by CiRA_F.\n<\/p>\n

\nTitle of the clinical trial<\/b>\n<\/p>\n

\nExploratory clinical study on the tolerability, safety and efficacy of iPS cell-derived platelets (MEG-002) in patients with thrombocytopenia\n<\/p>\n

\nPurpose of the clinical trial<\/b>\n<\/p>\n

\nTolerability, safety and efficacy of a single dose of MEG-002 in thrombocytopenia patients.\n<\/p>\n

\nDesign of the clinical trial<\/b>\n<\/p>\n\n\n\n\n
\n

\nPhase 1\/2 study:\n<\/p>\n<\/td>\n

\n

\nOpen-label, uncontrolled study \/ single-dose study\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nDose (1):\n<\/p>\n<\/td>\n

\n

\n3 units (0.6×10^11<\/sup> platelets)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nDose (2):\n<\/p>\n<\/td>\n

\n

\n10 units (2×10^11<\/sup> platelets)\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nPrimary endpoint<\/b>\n<\/p>\n\n\n\n
\n

\nSafety:\n<\/p>\n<\/td>\n

\n

\nIncidence of adverse events and side effects\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nEfficacy:\n<\/p>\n<\/td>\n

\n

\nCorrected count increment (CCI)\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nPeriod of the clinical trial<\/b>\n<\/p>\n

\nJuly 2021 \u2013 August 2022 (Planned to be extended)\n<\/p>\n

\nFor more information at Japan Registry of Clinical Trials<\/a> (jRCT).\n<\/p>\n

\nMegakaryon Corporation<\/b>\n<\/p>\n

\nHead office: Shimogyo-ku, Kyoto, Japan
\n
President: Kenichi Akamatsu\n<\/p>\n

\nURL: http:\/\/www.megakaryon.com\/en<\/a>\n<\/p>\n

\nMegakaryon Corporation was established in 2011 with the aim of utilizing technologies invented by Professor Koji Eto and others for producing platelets from human iPSCs for clinical application. By developing large-scale manufacturing of human iPSC-derived platelets with no risk of infection, we aim to supply platelets to medical facilities around the world.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia Contact:<\/b>
Megakaryon Corporation
\n
Tsuyoshi Ayabe
\n
info@megakaryon.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

KYOTO, Japan–(BUSINESS WIRE)–Megakaryon Corporation (hereinafter, Megakaryon) today announces its clinical trial of allogenic human iPSC-derived HLA homozygous platelets (Development Code: MEG-002) in collaboration with Kyoto University Hospital, Center for iPS Cell Research and Application, Kyoto University (CiRA) and CiRA Foundation (CiRA_F). Initial administration to the first subject was successful and with no reported adverse events. … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-44601","6":"format-standard","7":"category-industry"},"yoast_head":"\nMegakaryon Corporation Initiates First-in-Human Clinical Trial of Allogenic Human iPSC-Derived HLA Homozygous Platelets (MEG-002) - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/megakaryon-corporation-initiates-first-in-human-clinical-trial-of-allogenic-human-ipsc-derived-hla-homozygous-platelets-meg-002\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Megakaryon Corporation Initiates First-in-Human Clinical Trial of Allogenic Human iPSC-Derived HLA Homozygous Platelets (MEG-002) - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"KYOTO, Japan–(BUSINESS WIRE)–Megakaryon Corporation (hereinafter, Megakaryon) today announces its clinical trial of allogenic human iPSC-derived HLA homozygous platelets (Development Code: MEG-002) in collaboration with Kyoto University Hospital, Center for iPS Cell Research and Application, Kyoto University (CiRA) and CiRA Foundation (CiRA_F). 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