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Australia-based Cynata Therapeutics has secured ethics committee approval to conduct a clinical trial of its Cymerus mesenchymal stem cells (MSCs) to treat adult Covid-19 patients admitted to intensive care.
Called MEND, the open-label, randomised controlled trial will assess early efficacy of Cymerus MSCs. It builds on the company’s positive pre-clinical study results in ARDS, sepsis and cytokine release syndrome, which are known characteristics of severe Covid-19.
The study will be 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.
Cynata Therapeutics CEO and managing director Dr Ross Macdonald said: “Our substantial pre-clinical database in relevant disease models, together with the urgent need for more effective treatments for critically ill patients with Covid-19, allowed us to accelerate planning and rapidly achieve ethics committee approval.
“This trial forms part of a broader clinical development strategy for our Cymerus MSC product to be trialled in COVID-19 patients in other countries.
“Our decision to focus on this new clinical development area is a logical and prudent step based on the current global environment and Cynata’s solid pre-clinical foundations in respiratory and related diseases.”
The MEND trial will enrol a total of 24 adults admitted to intensive care due to Covid-19 and respiratory distress. Twelve patients will be given Cymerus MSC infusions plus standard of care, while the remaining will receive current standard of care.
Primary endpoints will be improvement in PaO2/FiO2 ratio by day 7, along with safety and tolerability up to day 28.
Currently, the company is exploring opportunities to expand the trial.
In preclinical studies, Cymerus MSCs have showed promise in various conditions caused by severe Covid-19, significantly in ARDS and other inflammatory conditions such as sepsis and cytokine release syndrome.