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Cellenkos Receives FDA Clearance of Investigational New Drug (IND) Application for CK0803 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

CK0803 are neurotropic, allogeneic, umbilical cord blood derived T regulatory (Treg) cells CK0803 represents the company's fifth program to receive IND Clearance utilizing Cellenkos' proprietary CRANEtechnology HOUSTON, Sept. 22, 2022 /PRNewswire/ Cellenkos, Inc., a clinical stage biotech company that focuses on developing transformative cellular therapeutics for treatment of inflammatory disorders and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1 safety study followed by a Phase 1b randomized, double blind, placebo control trial of CK0803, neurotrophic allogeneic Treg cells, in patients with amyotrophic lateral sclerosis (ALS). The primary objective of the upcoming Phase 1 study is to establish safety and tolerability of multiple doses of CK0803 administered intravenously in patients with ALS. The goal of the Phase 1b, randomized, double-blinded, place ....

United States , Tara Sadeghi , Neil Shneider , Cellenkos Inc , Prnewswire Cellenkos Inc , Center At Columbia University , Drug Administration , Investigational New Drug , Rating Scale Revised , Lou Gehrig , Columbia University , Chief Operating Officer , K0803 Are Neurotropic , Mbilical Cord Blood Derivedt Regulatory Treg Cells Ck0803 Represents The Company 39s Fifth Program To Receive Ind Clearance Utilizing Cellenkos 39 Proprietary Cranetechnology Houston , Sept 22 , 022 Prnewswire Cellenkos , A Clinical Stage Biotech Company That Focuses On Developing Transformative Cellular Therapeutics For Treatment Of Inflammatory Disorders And Autoimmune Diseases , Oday Announced That The Us Food And Drug Administration Fda Has Cleared Its Investigational New Ind Application To Initiatea Phase 1 Safety Study Followed Bya 1b Randomized , Double Blind , Lacebo Control Trial Of Ck0803 , Eurotrophic Allogeneic Treg Cells , N Patients With Amyotrophic Lateral Sclerosis Als The Primary Objective Of Upcoming Phase 1 Study Is To Establish Safety And Tolerability Multiple Doses Ck0803 Administered Intravenously In Goal 1b , Double Blinded , Lacebo Control Trial Is To Provide Further Safety Data And Evaluate The Impact Of Ck0803 On Combined Assessment Function Survival Cafs That Ranks Patients 39 Clinical Outcomes Based Time Change In Als Functional Rating Scale Revised Alsfrsr Score Quot This An Exciting Opportunity Applya Promising , Off The Shelf , Egulatoryt Cell Therapeutic To The Treatment Of Als ,

TRANSFORM 1 enrollment completed: A crucial RCT ready to redefine the DCB Angioplasty Mechanism

Birmingham [England], September 14 (ANI/PRNewswire): Concept Medical announces the successful completion of the TRANSFORM 1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FOR MagicTouch Sirolimus Coated Balloon). The Randomized Controlled Trial (RCT) was conceptualized with the aim of understanding how the treatment indications and applications of Drug-Coated Balloon (DCB) in coronary artery disease (CAD) can be broadened. This prospective, randomized, multi-centre, RCT focusing on small vessels, de-novo coronary lesion treatment enrolled the culminating 114th patient on August 31 at Heartlands Hospital, Birmingham by Dr Sandeep Basavarajaiah and the team completing the enrollment target with ease. The first of its kind angiographic RCT enrolled 114 patients with a head-to-head comparison between paclitaxel and sirolimus in small vessels (<=2.75 mm), de-novo coronary artery lesions. Patients were randomized in a 1:1 fashion between Magic Touch (Concept Medical ....

United States , United Kingdom , East Sussex , Bernardo Cortese , Sandeep Basavarajaiah , Patrickw Serruys , Neob Braun Melsungen , Core Lab , Nanolute Technology , Concept Medical , Touch Sirolimus Coated Balloon , Randomized Controlled Trial , Drug Coated Balloon , Heartlands Hospital , Magic Touch , Sequent Please Neo , Antonio Colombo , Patrick Serruys , Net Gain , Coherence Tomography , Quantitative Coronary Angiography , Co Chair Dr Bernardo Cortese , Small Vessels , Interventional Cardiology , Birmingham England , Eptember 14 Ani Prnewswire Concept Medical Announces The Successful Completion Of Transform 1 Rct Treatment Small Coronary Vessels Randomized Controlled Trial For Magictouch Sirolimus Coated Balloon Was Conceptualized With Aim Understanding How Indications And Applications Drug Dcb In Artery Disease Cad Can Be Broadened This Prospective ,