US-based biotechnology company Athersys has begun enrolling patients in the third and final cohort of a Phase II study of the MultiStem (invimestrocel) cell therapy following haemorrhagic trauma.
The placebo-controlled, double-blind MATRICS-1 study will assess MultiStem’s safety and effectiveness for the prevention and early treatment of complications after severe traumatic injury.
Patients who have survived initial treatment and have been admitted to the intensive care unit are being enrolled in the study.
They will be randomised to receive MultiStem or placebo within hours of hospitalisation and standard of care.
The study intends to enrol 140 patients and will be conducted at the University of Texas Health Science Center at Houston (UTHealth Houston) and Memorial Hermann-Texas Medical Center.
Medical Technology Enterprise Consortium (MTEC) will support the study in partnership with the US Department of Defence, while Memorial Hermann Foundation will provide funding.
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By GlobalDataAthersys CEO Dan Camardo said: “We’re excited to move forward and initiate Cohort III of this important trial with our partners at UTHealth Houston, Hermann-Texas Medical Center and DoD/MTEC based on a positive DSMB review.
“MultiStem’s unique mechanism of action has the potential to address the often fatal complications that occur following a severe traumatic event.
“The final cohort will utilise clinical product manufactured using a 3D bioreactor process and all doses are readily available through our contract manufacturer.”
MultiStem is designed to protect at-risk tissue at the site of injury, reduce inflammatory damage and upregulate reparative aspects of the local and systemic immune system.
Athersys said the drug could provide a ‘meaningful’ benefit to patients based on its efficacy profile, novel mechanisms of action and ‘favourable and consistent’ tolerability demonstrated in clinical studies.
Based in Cleveland, Ohio, Athersys works to discover and develop therapeutic product candidates that could extend and enhance the quality of human life.
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