University of Texas Health Science Center at Houston (UTHealth) in the US has secured funding to conduct a Phase II trial of MultiStem for use in the early treatment and prevention of complications following severe traumatic injury.
The funding has been provided through a public/private partnership that includes Medical Technology Consortium (MTEC), Memorial Hermann Foundation and Athersys.
MTEC’s funding makes up a sum of $2m, while Memorial Hermann Foundation has provided $1.5m. Athersys will provide its investigational stem cell therapy, MultiStem, in addition to regulatory and operational support for the trial.
The proposed double-blind, placebo-controlled trial expects to enrol around 150 severely injured trauma patients within hours of hospitalisation at Memorial Hermann-TMC, US.
Its design is yet to be reviewed by the US Food and Drug Administration (FDA) and receive approval from the UTHealth Internal Review Board, thereby making the design subject to change.
Once approved, UTHealth McGovern Medical School Neurosciences George and Cynthia Mitchell Distinguished Chair Charles Cox Jr will become the principal investigator of the trial.
Cox Jr said: “Traumatic injury is the leading cause of death and disability among children and members of the military, and also has a significant impact on the elderly.
“Following serious trauma, an acute hyperinflammatory response can be triggered, impairing recovery and leading to additional complications.
“Our prior research demonstrates that administration of MultiStem following acute neurological injury can help improve recovery and reduce the occurrence or severity of certain complications, so we are excited about the clinical potential in this area.”
The MultiStem cell therapy is a patented regenerative medicine product that has demonstrated potential to help tissue repair and healing in various ways, including through the therapeutic factors produced in response to signals of inflammation and tissue damage.