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Data Safety Monitoring Board Recommends Continuation of Phase 1/2 Clinical Trial with Sernova's Cell Pouch System(TM) in Patients with Type-1 Diabetes
(TheNewswire) Confirms Ongoing Safety and Tolerability of Sernova’s Ce...
About this update from Sernova Biotherapeutics Inc
[{"type":"text","content":"Data Safety Monitoring Board Recommends Continuation of Phase 1/2 Clinical Trial with Sernova's Cell Pouch System(TM) in Patients with Type-1 Diabetes\n \n \n (TheNewswire)\n \n \n \n \n \n \n \n \n Confirms Ongoing Safety and\nTolerability of Sernova’s Cell Pouch\n \n \n \n LONDON, ONTARIO –\n \n TheNewswire -\n \n March 17, 2022\n– Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE:PSH), a clinical- stage\ncompany and leader in regenerative medicine cell therapeutics, is\npleased to announce that the Data Safety Monitoring Board\n(\"DSMB\") has completed the third annual review of\nSernova’s ongoing Phase 1/2 clinical study “Safety, Tolerability\nand Efficacy Study of Sernova’s Cell Pouch for Clinical Islet\nTransplantation” in patients with Type-1 Diabetes (T1D) who suffer\nfrom hypoglycemia unawareness and severe hypoglycemic events.\n \n \n In their assessment, the DSMB recommended that the clinical study\nshould continue according to the study plan.\n \n \n The DSMB is an independent committee of clinical experts who review\nthe accumulated trial data to evaluate patient safety and ensure the\nintegrity of the study data.\n \n \n “This recommendation from the DSMB affirms our understanding of the\nsafety of Cell Pouch in this patient population transplanted with\nhuman donor islets.  We look forward to sharing updates from the\nstudy through upcoming conference presentations by Dr. Piotr\nWitkowski, the trial Principal Investigator.” said Dr. Philip\nToleikis, President & CEO of Sernova Corp.\n \n \n \n For more information on this clinical trial, please\nvisit\n \n \n \n www.clinicaltrials.gov/ct2/show/NCT03513939\n \n \n \n \n .\n \n \n \n For more\ninformation on enrollment and recruitment details please visit\n \n \n \n www.pwitkowski.org/sernova\n \n \n \n \n .\n \n \n \n \n \n ABOUT HYPOGLYCEMIA UNAWARENESS\n \n \n \n Hypoglycemia unawareness is a person’s inability to recognize the\nsymptoms of low blood sugar before they become severe enough to be\nincapacitating or even fatal, which may occur when blood glucose\nlevels are below 3.0 mmol/L. It is estimated that approximately 15% of\npeople with T1D, or approximately 240,000 people, are affected by\nhypoglycemia unawareness in the US alone.\n \n \n Severe symptoms of low blood sugar include confu...