Stem Cell Therapeutics Corp: Traumatic Brain Injury Clinical Study Gains IRB Approval at University of Calgary
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Stem Cell Therapeutics Corp. announces that the IRB (Institutional Review Board) at the University of Calgary/Foothills Hospital has approved the SCT-sponsored investigator-lead Phase IIa study entitled "A Phase IIa, Single Center, Open Label Study to Characterize the Safety of Human Chorionic Gonadotrophin (hCG) and Epoeitin Alpha (EPO) in Traumatic Brain Injury".
The study which was approved and which would be, lead by Dr David Zygun, of the University of Calgary, is a single center open label study to characterize the safety of hCG and EPO in traumatic brain injury patients (TBI). A series of efficacy endpoints are part of the trial design in order to access various aspects of neurological status.
Dr Alan Moore, President and CEO of SCT said "We are excited to see this study reach final approval stage, which is a significant milestone, and look forward to determine the effects of the hCG+EPO regimen in patients with TBI. However, as stated in our June 25, 2010 press release, the Company continues to move forward as a biotech company considering a range of options. Management continues to focus its efforts on pursuing the end-of-Phase II meeting with the FDA for the NTx®-265 stroke therapy while concurrently reviewing alternatives for pursuing the traumatic brain injury (TBI) and multiple sclerosis (MS) study opportunities."
The study which was approved and which would be, lead by Dr David Zygun, of the University of Calgary, is a single center open label study to characterize the safety of hCG and EPO in traumatic brain injury patients (TBI). A series of efficacy endpoints are part of the trial design in order to access various aspects of neurological status.
Dr Alan Moore, President and CEO of SCT said "We are excited to see this study reach final approval stage, which is a significant milestone, and look forward to determine the effects of the hCG+EPO regimen in patients with TBI. However, as stated in our June 25, 2010 press release, the Company continues to move forward as a biotech company considering a range of options. Management continues to focus its efforts on pursuing the end-of-Phase II meeting with the FDA for the NTx®-265 stroke therapy while concurrently reviewing alternatives for pursuing the traumatic brain injury (TBI) and multiple sclerosis (MS) study opportunities."
