Stem Cell Therapeutic Corp. has completed a preclinical comparator study designed
to characterize the neuroregenerative effects of stem cell proliferative agents
plus EPO in an animal model of traumatic brain injury (“TBI”). This study represents
a promising new program launch that builds upon intellectual property held by SCT
and supported by fundamental findings from the laboratory of Dr. Samuel Weiss at
the University of Calgary. Acute traumatic injury to the head resulting from automobile
accidents, concussive explosions or serious athletic impact to the head represents
serious events that cause loss of independence and demand intense medical intervention
with recovery periods that often persist for months or years. A therapy that induces
improved neurological recovery or functional recovery after an acute injury, would
increase patient independence, decrease rehabilitation time and cost, represents
a new important scientific advancement and medical development.
A preclinical comparator study was sponsored by SCT and was designed to characterize
the ability of either hCG or prolactin followed by EPO to promote recovery of the
brain following moderate-to-serious acute cortical (white matter) injury to the
brain. The objective of this study, conducted at Louisiana State University under
the leadership of Dr. Ludmila Belayev, was to compare two proliferative agents,
hCG plus EPO versus prolactin plus EPO, in a rat animal model of TBI. Top-line analysis
shows that both regimens work equally well to reverse the behavioral and anatomical
effects of TBI. Formal data from this study will be presented in the future in written
and oral format.
Building upon the results of this animal study, and those previously obtained, a
Phase IIa TBI clinical study was anticipated to start at one site in Canada in Q3
2008. This study was also placed on clinical hold due to an unrelated German study
at the request of Health Canada. On January 28, 2010, SCT announced it has received
a No Objection Letter (“NOL”) from Health Canada for the Company supported, investigator-led
Phase IIa, single centre, open label study to characterize the safety of human Chorionic
Gonadotropin (“hCG”) & Erythropoietin (“EPO”) in severe TBI patients. Dr. David
Zygun, MD, MSc, FRCPC, 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 TBI trial. This Phase IIa trial in TBI patients is expected to begin enrolling
patients in H1 2010.