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Sernova Announces Second Annual Data Safety Monitoring Board Review of its Diabetes Cell Pouch System(tm) Clinical Trial and Recommendation for Protocol Continuation
(TheNewswire) Ongoing Safety of Sernova's Clinical Trial Conf...
About this update from Sernova Biotherapeutics Inc
[{"type":"text","content":"Sernova Announces Second Annual Data Safety Monitoring Board Review of its Diabetes Cell Pouch System(tm) Clinical Trial and Recommendation for Protocol Continuation\n \n \n (TheNewswire)\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n Ongoing Safety of\nSernova's Clinical Trial Confirmed\n \n \n \n L\n \n ondon, Ontario\n \n -\n \n TheNewswire\n-\n \n February 18, 2021 - Sernova Corp. (TSXV:SVA) (OTC:SEOVF)\n(FSE:PSH), a clinical-stage company and leader in regenerative\nmedicine therapeutics, is pleased to announce that the clinical trial\nindependent Data Safety Monitoring Board (\"DSMB\") has\ncompleted the second planned annual review of the ongoing\n \n Safety, Tolerability and Efficacy Study of\nSernova's Cell Pouch™ for Clinical Islet Transplantation\n \n Phase I/II clinical trial in patients with severe hypoglycemia\nunawareness and inability to produce their own insulin.\n \n \n The DSMB recommended that the Phase I/II clinical study should\ncontinue according to the study protocol and any related amendments.\nIn their assessment, the DSMB did not raise any concerns regarding\npatient safety.\n \n \n \"We are pleased with the second annual independent DSMB review of\nour Phase I/II clinical trial,\" said Dr. Philip Toleikis,\nPresident & CEO Sernova Corp. \"We thank the DSMB for its\ndiligence, guidance and support as Sernova continues progressing the\nclinical trial.\"\n \n \n The DSMB is an independent group of clinical research experts who\nreview the accumulated data to permit a thorough evaluation of patient\nsafety and to ensure the integrity of the study's data and progress\ntowards completion.\n \n \n \n ABOUT SERNOVA'S CLINICAL TRIAL\n \n \n \n \n Sernova is conducting a Phase I/II non-randomized,\nunblinded, single-arm, company-sponsored trial to assess the safety\nand tolerability of islet transplantation into the company's patented\nCell Pouch in diabetic subjects with hypoglycemia unawareness and an\ninability to produce their own insulin. The secondary objective is to\nassess efficacy through a series of defined measures.  Eligible\nsubjects are implanted with Cell Pouches. Following development of\nvascularized tissue chambers within the Cell Pouch, subjects are then\nstabilized on immunosuppression and a dose of purified islets, under\nstrict release criteria, transplanted ...