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Creative Medical Technology Holdings Engages Highly Respected International CRO for Phase 1 / 2 Clinical Trial to Treat Type 1 Diabetes Using CELZ-201

CELZ-201 is the First Novel Allogenic Cellular Therapy in the Dorsal Artery of the Pancreas in the United States PHOENIX--(BUSINESS WIRE)-- Creative Medical

articleCreative Medical Technology Holdings, Inc.March 7, 20235/company/creative-medical-technology-holdings-inc/news/creative-medical-technology-holdings-engages-highly-respected-international-cro-for-phase-1-2-clinical-trial-to-treat-type-1-diabetes-using-celz-201
Creative Medical Technology Holdings Engages Highly Respected International CRO for Phase 1 / 2 Clinical Trial to Treat Type 1 Diabetes Using CELZ-201

About this update from Creative Medical Technology Holdings, Inc.

[{"type":"text","content":"\nCELZ-201 is the First Novel Allogenic Cellular Therapy in the Dorsal Artery of the Pancreas in the United States\n\n PHOENIX--(BUSINESS WIRE)--\nCreative Medical Technology Holdings, Inc. (\"Creative Medical Technology Holdings\" or the \"Company\") (NASDAQ: CELZ), a biotechnology company working to revolutionize care through the development of potentially best-in-class regenerative therapeutics, today announced that it has engaged Syneos Health (NASDAQ: SYNH) as the contract research organization (CRO) for its upcoming Phase 1/2 randomized, controlled clinical trial for the treatment of Type 1 Diabetes using the Company’s CELZ-201 cell therapy. The objective of the study, which is expected to commence during the first quarter of 2023, is to determine the safety and efficacy of CELZ-201 administration.\n\nThis engagement follows the Company’s recent announcements regarding the receipt of Institutional Review Board approval to proceed with this clinical trial (February 2023) and clearance by the U.S. Food and Drug Administration of its Investigational New Drug application for CELZ-201 to treat Type 1 Diabetes (November 2022).\n\nThe Company believes that CELZ-201 leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells® (PRDC) to multi-potentialities, including self-renewal ability, low antigenicity, reduced toxicity, without immunosuppression and with large-scale clinical expansion.\n\n“The commencement of this first-in-country clinical trial is a milestone event for Creative Medical Technology Holdings and a reflection of our commitment to developing novel therapies with the potential to address areas of high unmet medical need,” said Timothy Warbington, CEO of Creative Medical Technology Holdings, Inc. “We are very pleased to have engaged Syneos Health, which brings a wealth of experience, insight, and know-how in the advancement of important therapies such as CELZ-201.”\n\nMr. Warbington concluded, “We remain supported in our efforts by a talented and dedicated team of employees and collaborators, and a strong financial position that provides us with the resources to drive our clinical development initiatives.”\n\nAbout Type 1 Diabetes\n\nAs of 2019, there were 1.6 million adults aged 20 years or older diagnosed with Type 1 Diabetes (T1D) in the United States. The economic burden caused by T1D a...

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