Effect of Recombinant Erythropoietin on Numbers of Circulating Endothelial Progenitor Cells in Subacute TBI
Status:
Withdrawn
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
- Traumatic brain injury (TBI) is the leading cause of death and disability in people
under age 45 in industrialized countries. Significant numbers of US veterans from the
wars in Iraq and Afghanistan return with TBI. However, to date, there are no specific
neuroprotective treatment options with proven clinical efficacy.
- Erythropoietin (EPO) is approved by the FDA to treat anemia and has comprehensive
preclinical data supporting its neuroprotective and neuroregenerative efficacy following
traumatic (TBI) and a wide range of other acquired brain insults. Injury to small and
medium-sized cerebral blood vessels is a well recognized consequence of TBI. EPO
increases production of endothelial progenitor cells (EPCs) and promotes angiogenesis
and neovascularization after TBI. EPO also promotes neurogenesis and improves functional
recovery in animals after experimental stroke and TBI. Neovascularization is coupled
with neurogenesis, and augmentation of both processes by EPO may result in lessened
cognitive deficits. Neovascularization by EPO may prevent post-traumatic deficits in
cerebrovascular reactivity (CVR), which can be measured noninvasively using magnetic
resonance imaging (MRI).
- This proposal is for a randomized, placebo-controlled pilot clinical trial designed to
obtain data on the effects of EPO in humans with persistent post-concussive symptoms
after TBI. The primary objective is to evaluate effect of 4 week administration of
recombinant erythropoietin on numbers of circulating endothelial progenitor cells in
patients with persistent symptoms during the subacute period after TBI. This information
will guide the design of a future definitive study.
Phase:
Phase 2
Details
Lead Sponsor:
Uniformed Services University of the Health Sciences