Sernova Corp., a clinical- stage company and leader in regenerative medicine cell therapeutics, is pleased to announce that the Data Safety Monitoring Board (“DSMB”) has completed the third annual review of Sernova’s ongoing Phase 1/2 clinical study “Safety, Tolerability and Efficacy Study of Sernova’s Cell Pouch for Clinical Islet Transplantation” in patients with Type-1 Diabetes (T1D) who suffer from hypoglycemia unawareness and severe hypoglycemic events.
In their assessment, the DSMB recommended that the clinical study should continue according to the study plan.
The DSMB is an independent committee of clinical experts who review the accumulated trial data to evaluate patient safety and ensure the integrity of the study data.
“This recommendation from the DSMB affirms our understanding of the safety of Cell Pouch in this patient population transplanted with human donor islets. We look forward to sharing updates from the study through upcoming conference presentations by Dr. Piotr Witkowski, the trial Principal Investigator.” said Dr. Philip Toleikis, President & CEO of Sernova Corp.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.