Safety of Autologous Marrow Stromal Cells After Stroke

描述（由申请人提供）：本研究将是一项I期剂量递增试验，以评估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。在美国，中风仍然是导致成人残疾的主要原因，大多数患者没有及早获得医疗保健，无法从超急性中风治疗中获益。在脑卒中动物模型中，梗死后数天给予MSC与改善行为结果相关。在一些非脑血管诊断的人类安全性研究中发现MSC是安全的。因此，MSC可能代表了一种可以改善人类卒中患者预后的治疗方法，具有较宽的干预时间窗。

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.