Stem Cell Therapeutics has received a no objection letter from the Health Canada for the company supported, investigator led Phase IIa single center, open label study to characterize the safety of human chorionic gonadotropin and erythropoietin in severe traumatic brain injury.
David Zygun, assistant professor in the departments of critical care medicine, clinical neurosciences and community health sciences, University of Calgary, Foothills Medical Centre, Calgary Health Region, will be the principal investigator for this Phase IIa traumatic brain injury (TBI) study.
The protocol of the Phase IIa TBI study has been reviewed by Health Canada. Approval by the University of Calgary's Office of Medical Bioethics is pending and once received will permit immediate enrollment at the Calgary Foothills Medical Centre.
Alan Moore, president and CEO of Stem Cell, said: "The Phase IIa TBI therapeutic regimen is the same treatment being used in the Phase IIb Regenesis stroke program. Hence, we anticipate a supportive and expanding safety database in addition to endpoint measures of activity and efficacy."