Safety of Autologous Marrow Stromal Cells After Stroke

中风后自体骨髓基质细胞的安全性

• 批准号: 6680793
• 负责人: Steven C. Cramer
• 金额: $ 13.5万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-01 至 2006-05-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6680793
• 关键词: autotransfusion; bone marrow; cerebral ischemia /hypoxia; clinical research; connective tissue cells; fine needle aspiration; functional ability; human morbidity; human mortality; human subject; human therapy evaluation; intravenous administration; magnetic resonance imaging; outcomes research; patient oriented research; stroke; stroke therapy; therapy adverse effect; thrombosis

DESCRIPTION (provided by the applicant): This study will be a Phase I, dose-escalation trial to evaluate the safety of autologous Mesenchymal Stromal Cell (MSC) transfusion in patients with acute ischemic stroke. Stroke remains the leading cause of adult disability in the U.S. Most patients do not access healthcare early enough to benefit from hyperacute stroke therapies. In animal models of stroke, administration of MSC days after infarct has been associated with improved behavioral outcome. MSC has been found to be safe in several safety studies of humans with non-cerebrovascular diagnoses. MSC may, therefore, represent a treatment that can improve outcome in human stroke patients with a wide time-window for intervention. The specific aims will evaluate whether the morbidity and mortality rates among patients receiving this treatment are higher than expected, according to specific primary and secondary endpoints. The primary endpoint focuses on mortality and major thrombotic/infectious adverse events 90 days after treatment. The secondary endpoints consider these events over a longer term, and further evaluate potential adverse effects on systemic and neurological function. The long-term objective is to identify a treatment that is safe, improves long-term outcome in patients with acute ischemic stroke, and can be administered to a majority of patients with a new diagnosis of stroke. This study is a Phase I safety trial, and thus represents the first step in evaluating autologous MSC transfusion in this regard.

描述（由申请方提供）：本研究将是一项I期、剂量递增试验，旨在评价自体间充质基质细胞（MSC）输注在急性缺血性卒中患者中的安全性。 中风仍然是美国成年人残疾的主要原因，大多数患者没有足够早地获得医疗保健，无法从超急性中风治疗中获益。 在中风的动物模型中，在梗死后数天给予MSC与改善的行为结果相关。 在几项针对非脑血管疾病患者的安全性研究中发现MSC是安全的。 因此，MSC可能代表了一种可以改善人类中风患者预后的治疗方法，具有较宽的干预时间窗。 具体目标将根据具体的主要和次要终点，评价接受该治疗的患者的发病率和死亡率是否高于预期。 主要终点关注治疗后90天的死亡率和主要血栓/感染不良事件。 次要终点考虑了这些事件的长期影响，并进一步评价了对全身和神经功能的潜在不良影响。 长期目标是确定一种安全的治疗方法，改善急性缺血性卒中患者的长期结局，并可用于大多数新诊断为卒中的患者。 这项研究是一项I期安全性试验，因此代表了在这方面评估自体MSC输注的第一步。