From the Division of Cardiology, Cedars-Sinai Medical Center, The Heart Institute, Los Angeles, CA (T.D.H.); Division of Cardiology (T.D.H.) and Cardiovascular Division (J.H.T.), Minneapolis Heart Institute Foundation, MN; Division of Cardiothoracic Surgery (B.L.H.) and Clinical Cardiovascular Research Center (C.A.E.), Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX; Division of Cardiovascular Surgery, DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX (B.B.); Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City (D.A.B., A.N.P.); and Aastrom Biosciences, Inc, Ann Arbor, MI (A.E.R., D.R.).
Circ Res. 2014 Sep 26;115(8):730-7. doi: 10.1161/CIRCRESAHA.115.304554. Epub 2014 Aug 20.
Ixmyelocel-T is associated with a wide range of biological activities relevant to tissue repair and regeneration.
To evaluate the safety and efficacy of ixmyelocel-T in 2 prospective randomized phase 2A Trials administered via minithoracotomy or intramyocardial catheter injections in patients with dilated cardiomyopathy (DCM) stratified by ischemic or nonischemic status.
In IMPACT-DCM, patients were randomized to either ixmyelocel-T or standard-of-care control in a 3:1 ratio (n=39); ixmyelocel-T was administered intramyocardially via minithoracotomy. In Catheter-DCM, patients were randomized to either ixmyelocel-T or standard of care control in a 2:1 ratio (n=22); ixmyelocel-T was administered intramyocardially using the NOGA Myostar catheter. Only patients randomized to ixmyelocel-T underwent bone marrow aspiration and injections. In the 2 studies, a total of 61 patients were randomized, and 59 were treated or received standard of care. Fewer ischemic patients treated with ixmyelocel-T experienced a major adverse cardiovascular event during follow-up when compared with control patients. A similar benefit was not seen in the nonischemic patients. Heart failure exacerbation was the most common major adverse cardiovascular event. Ixmyelocel-T treatment was associated with improved New York Heart Association class, 6-minute walk distance, and Minnesota Living with Heart Failure Questionnaire scores in the ischemic population relative to control; a similar trend was not observed in the nonischemic population.
Intramyocardial injection with ixmyelocel-T reduces major adverse cardiovascular event and improves symptoms in patients with ischemic DCM but not in patients with nonischemic DCM.
Ixmyelocel-T 与多种与组织修复和再生相关的生物学活性有关。
通过微创开胸术或心肌内导管注射，在缺血性或非缺血性扩张型心肌病（DCM）患者中，评估 ixmyelocel-T 在 2 项前瞻性随机 2A 期试验中的安全性和疗效，这些患者按分层。
在 IMPACT-DCM 中，患者按 3:1 的比例随机分为 ixmyelocel-T 或标准治疗对照（n=39）；ixmyelocel-T 通过微创开胸术进行心肌内给药。在 Catheter-DCM 中，患者按 2:1 的比例随机分为 ixmyelocel-T 或标准治疗对照（n=22）；ixmyelocel-T 通过 NOGA Myostar 导管进行心肌内给药。只有随机分配到 ixmyelocel-T 的患者接受了骨髓抽吸和注射。在这 2 项研究中，共有 61 名患者被随机分组，59 名患者接受了治疗或接受了标准治疗。与对照组相比，接受 ixmyelocel-T 治疗的缺血性患者在随访期间发生主要不良心血管事件的人数较少。在非缺血性患者中没有观察到类似的益处。心力衰竭恶化是最常见的主要不良心血管事件。与对照组相比，缺血性患者中 ixmyelocel-T 治疗与纽约心脏协会（NYHA）心功能分级、6 分钟步行距离和明尼苏达州心力衰竭生活质量问卷评分的改善相关；在非缺血性患者中没有观察到类似的趋势。
心肌内注射 ixmyelocel-T 可降低缺血性 DCM 患者的主要不良心血管事件发生率并改善症状，但对非缺血性 DCM 患者无效。
