Da Silva Jose S, Hare Joshua M
University of Miami, Miami, FL, USA.
Methods Mol Biol. 2013;1037:145-63. doi: 10.1007/978-1-62703-505-7_8.
Accumulating data support the use of bone marrow (BM)-derived MSCs in animal models (e.g., swine) to restore cardiac function and tissue perfusion in chronic cardiac injury. Based on results obtained in swine, we are currently conducting phase I/II clinical trials to address the safety, cell type, cell dose, delivery technique, and efficacy of MSCs in patients with chronic heart failure. MSCs for these trials are isolated from harvested BM and then processed and expanded for intracardiac injection. The BM-MSCs in use for the clinical trials are of clinical grade having been processed successfully in an FDA-approved cGMP facility.
越来越多的数据支持在动物模型(如猪)中使用骨髓来源的间充质干细胞来恢复慢性心脏损伤中的心脏功能和组织灌注。基于在猪身上获得的结果,我们目前正在进行I/II期临床试验,以探讨间充质干细胞在慢性心力衰竭患者中的安全性、细胞类型、细胞剂量、递送技术和疗效。这些试验所用的间充质干细胞从采集的骨髓中分离出来,然后进行处理和扩增,用于心内注射。用于临床试验的骨髓间充质干细胞是临床级别的,已在FDA批准的cGMP设施中成功处理。