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Australia-based Cynata Therapeutics has started patient enrolment in the MEND clinical trial of Cymerus mesenchymal stem cells (MSCs) in adults admitted to intensive care with Covid-19.
Cymerus MSC technology was previously assessed in preclinical models of asthma, acute respiratory distress syndrome (ARDS), cytokine release syndrome, diabetic wounds, heart attack and sepsis.
The open-label, randomised, controlled MEND Trial will evaluate the early efficacy of Cymerus MSCs in 24 patients admitted to intensive care with Covid-19 and respiratory distress.
It will performed at sites in New South Wales in alliance with the Cerebral Palsy Alliance Research Institute and the Covid-19 Stem Cell Treatment (CSCT) Group investigators.
Twelve participants in the trial will be given Cymerus MSC infusions, along with standard of care, while 12 patients will receive current standard of care in the control group.
The primary efficacy endpoint will be the improvement in PaO2/FiO2 ratio, which measures a low level of oxygen in the blood due to compromised lung function, by day seven.
In addition, primary endpoins include safety and tolerability up to day 28.
Cynata Therapeutics COO Dr Kilian Kelly said: “The trial builds on the solid pre-clinical foundations for the use of our Cymerus MSC technology in respiratory diseases, including acute respiratory distress syndrome (ARDS), as well as cytokine release syndrome and sepsis, all of which are hallmarks of critically ill Covid-19 patients.
“Cynata’s proprietary Cymerus technology uniquely enables the manufacture at scale of a consistent and robust MSC product without the substantial functional heterogeneity, such as lack of consistency, that has been observed between MSC batches derived from different donors.”
The company intends to progress Cymerus MSCs into Phase II trials for severe complications caused by Covid-19, graft-versus-host disease (GvHD), critical limb ischemia, and a Phase III study for osteoarthritis.