Adler Dale S, Lazarus Hillard, Nair Ravi, Goldberg Jonathan L, Greco Nicholas J, Lassar Tom, Laughlin Mary J, Das Hiranmoy, Pompili Vincent J
Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Front Biosci (Elite Ed). 2011 Jan 1;3(2):506-14. doi: 10.2741/e265.
The Phase I clinical study was designed to assess the safety and feasibility of a dose escalating intracoronary infusion of autologous bone marrow (BM)-derived CD133+ stem cell therapy to the patients with chronic total occlusion (CTO) and ischemia. Nine patients were received CD133+ cells into epicardial vessels supplying collateral flow to areas of viable ischemic myocardium in the distribution of the CTO. There were no major adverse cardiac events (MACE), revascularization, re-admission to the hospital secondary to angina, or acute myocardial infarction (AMI) for the 24-month period following cellular infusion. In addition, there were no periprocedural infusion-related complications including malignant arrhythmias, loss of normal coronary blood flow or acute neurologic events. Cardiac enzymes were negative in all patients. There was an improvement in the degree of ischemic myocardium, which was accompanied by a trend towards reduction in anginal symptoms. Intracoronary infusion of autologous CD133+ marrow-derived cells is safe and feasible. Cellular therapy with CD133+ cells to reduce anginal symptoms and to improve ischemia in patients with CTO awaits clinical investigation in Phase II/III trials.
I期临床研究旨在评估对慢性完全闭塞（CTO）和缺血患者进行剂量递增的冠状动脉内输注自体骨髓（BM）来源的CD133 +干细胞治疗的安全性和可行性。9例患者接受了CD133 +细胞，通过心外膜血管输注到CTO分布区域中为存活的缺血心肌区域提供侧支血流的部位。在细胞输注后的24个月期间，未发生重大不良心脏事件（MACE）、血运重建、因心绞痛再次入院或急性心肌梗死（AMI）。此外，没有围手术期输注相关并发症，包括恶性心律失常、正常冠状动脉血流丧失或急性神经系统事件。所有患者的心肌酶均为阴性。缺血心肌程度有所改善，同时心绞痛症状有减轻趋势。冠状动脉内输注自体CD133 +骨髓来源细胞是安全可行的。用CD133 +细胞进行细胞治疗以减轻CTO患者的心绞痛症状并改善缺血情况，尚有待II/III期临床试验的临床研究。
