Clinical-stage biotechnology company Cynata Therapeutics Limited (ASX: CYP) has successfully completed a planned, routine review of the MEND clinical trial by the independent DSMB. The DSMB has recommended that the clinical trial continue as planned.
A review by an independent DSMB is consistent with good clinical practice in clinical trials. The primary responsibilities of the DSMB are to review and evaluate the available study data for participant safety, study conduct and progress, and to make recommendations concerning the continuation, modification, or termination of the trial.
Chief Operating Officer, Dr Kilian Kelly, said the study protocol for the MEND clinical trial includes oversight by a DSMB as well as provision for an interim review, which has now been successfully completed.
“We thank the members of the independent DSMB for completing this important review. The DSMB’s positive recommendation is an important milestone, which enables us to continue patient enrolment in the MEND clinical trial and advance toward our goal of completing the trial later this year.”
About the MEND Clinical Trial
The MEND Trial is being conducted at centres in New South Wales and Victoria in collaboration with the Cerebral Palsy Alliance Research Institute and investigators from the COVID-19 Stem Cell Treatment (CSCT) Group.
The study is an open- label, randomised controlled clinical trial to investigate early efficacy of Cymerus MSCs in 24 adult patients admitted to intensive care with respiratory failure. Twelve patients will be randomised to receive Cymerus MSC infusions, in addition to standard of care, while 12 patients will be randomised to the control group and will receive current standard of care.
The primary efficacy endpoint will be improvement in PaO2/FiO2 ratio (a measure of hypoxemia, a low level of oxygen in the blood caused by compromised lung function) by Day 7. Safety and tolerability up to Day 28 will also be a primary endpoint.