Effect of Administration of Recombinant Erythropoietin on Numbers of Circulating Endothelial Progenitor Cells in Patients With Persistent Symptoms During the Subacute Period After TBI
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Effect of 4 weeks of EPO administration on numbers of circulating EPCs in patients with persistent symptons during the subacute period after TBI.
研究概览
简要总结
Background:
- Traumatic brain injury (TBI) injures blood vessels in the brain. Endothelial progenitor cells (EPCs) help the body form new blood vessels. The drug erythropoietin (EPO) helps the body make more blood cells and might help make blood vessels. Researchers want to see if EPO helps people with TBI.
Objective:
- To see whether erythropoietin increases the number of endothelial progenitor cells circulating in the blood and changes reactivity of brain vessels.
Eligibility:
- Adults age 18 70 who had a TBI 3 7 days ago and still have symptoms.
Design:
- Participants will be screened with medical history and blood tests. Vital signs will be taken.
- Visit 1:
- Medical history, physical exam, and blood sample.
- Neuropsychological tests of memory, attention, and thinking. These include written and spoken questions, tests on paper or computer, and simple actions.
- Magnetic resonance imaging (MRI) scan with carbon dioxide. Participants will lie on a table that slides in and out of a metal cylinder. For part of the scan, participants will wear a breathing mask like a snorkel and wear a nose clip.
- Study drug or placebo injection under the skin of the arm, leg, or buttock.
- Visits 2, 3, and 4 will be 1 week apart.
- Blood sample.
- Review of TBI symptoms and any drug side effects.
- Study drug or placebo injection under the skin.
- Visit 5 will be 1 week after visit 4. Visit 6 will be 6 months after participants start the study.
- Blood sample.
- Review of TBI symptoms and any drug side effects.
- Neuropsychological tests.
- MRI with carbon dioxide.
详细描述
Objective
Traumatic brain injury (TBI) is the leading cause of death and disability in people under age 45 in industrialized countries 5;6. Significant numbers of US veterans from the wars in Iraq and Afghanistan return with TBI7. However, to date, there are no specific neuroprotective treatment options with proven clinical efficacy 8. 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) 4;9 and promotes angiogenesis and neovascularization after TBI. EPO also promotes neurogenesis and improves functional recovery in animals after experimental stroke10-12 and TBI.13;14 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.
Study Population
The study population will include 30 males and females with persistent post-concussive symptoms continuing up to 7 days after TBI. Participants will be military service members or civilians presenting as outpatients for clinical management of TBI or post-concussive symptoms at the Center for Neuroscience and Regenerative Medicine (CNRM)-affiliated hospitals. These include the Walter Reed National Military Medical Center (WRNMMC), Suburban Hospital (SH), and Washington Hospital Center (WHC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Effect of 4 weeks of EPO administration on numbers of circulating EPCs in patients with persistent symptons during the subacute period after TBI.
时间窗: 4 weeks
次要结局
- Safety of 4 weeks of EPO administration to TBI participants(4 weeks)
- Effect of 4 weeks of EPO administration on biomarkers(4 weeks)
- Effect of 4 weeks of EPO administration on MRI biomarkers of TBI recovery(4 weeks)
- Relationship between EPC levels at baseline after 4 weeks and neuropsychological performance following TBI.(Baseline)