ICREC Research Program, Fundació Institut d´Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP), Badalona, Spain.
CIBERCV, Instituto de Salud Carlos III, Madrid, Spain.
BMJ Open. 2017 Aug 4;7(8):e017187. doi: 10.1136/bmjopen-2017-017187.
Cardiac adipose tissue is a source of progenitor cells with regenerative capacity. Studies in rodents demonstrated that the intramyocardial delivery of cells derived from this tissue improves cardiac function after myocardial infarction (MI). We developed a new reparative approach for damaged myocardium that integrates the regenerative properties of cardiac adipose tissue with tissue engineering. In the adipose graft transposition procedure (AGTP), we dissect a vascularised flap of autologous pericardial adipose tissue and position it over the myocardial scarred area. Following encouraging results in acute and chronic MI porcine models, we performed the clinical trial (NCT01473433, AdiFLAP trial) to evaluate safety in patients with chronic MI undergoing coronary artery bypass graft. The good safety profile and trends in efficacy warranted a larger trial.
The AGTP II trial (NCT02798276) is an investigator initiated, prospective, randomised, controlled, multicentre study to assess the efficacy of the AGTP in 108 patients with non-revascularisable MI. Patients will be assigned to standard clinical practice or the AGTP. The primary endpoint is change in necrotic mass ratio by gadolinium enhancement at 91 and 365 days. Secondary endpoints include improvement in regional contractibility by MRI at 91 and 365 days; changes in functional MRI parameters (left ventricular ejection fraction, left and right ventricular geometric remodelling) at 91 and 365 days; levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) at 7, 91 and 365 days; appearance of arrhythmias from 24 hour Holter monitoring at 24 hours, and at 91 and 365 days; all cause death or re-hospitalisation at 365 days; and cardiovascular death or re-hospitalisation at 365 days.
The institutional review board approved the trial which will comply with the Declaration of Helsinki. All patients will provide informed consent. It may offer a novel, effective and technically simple technique for patients with no other therapeutic options. The results will be submitted to indexed medical journals and national and international meetings.
ClinicalTrials.gov: NCT02798276, pre-results.
心脏脂肪组织是具有再生能力的祖细胞的来源。在啮齿动物中的研究表明，将来源于这种组织的细胞经心肌内注射，可改善心肌梗死后的心脏功能。我们开发了一种新的心肌损伤修复方法，将心脏脂肪组织的再生特性与组织工程相结合。在脂肪组织移植转位术（AGTP）中，我们解剖自体心包脂肪组织的血管化皮瓣，并将其置于心肌瘢痕区域。在急性和慢性心肌梗死猪模型中取得令人鼓舞的结果后，我们进行了临床试验（NCT01473433，AdiFLAP 试验），以评估该方法在接受冠状动脉旁路移植术的慢性心肌梗死患者中的安全性。良好的安全性和疗效趋势证明了更大规模试验的必要性。
AGTP II 试验（NCT02798276）是一项由研究者发起的、前瞻性的、随机的、对照的、多中心研究，旨在评估 108 例不可再血管化心肌梗死患者中 AGTP 的疗效。患者将被分配至标准临床治疗或 AGTP。主要终点是钆增强 91 天和 365 天的坏死质量比变化。次要终点包括 91 天和 365 天 MRI 显示的区域性收缩性改善；91 天和 365 天功能 MRI 参数（左心室射血分数、左、右心室几何重构）的变化；7 天、91 天和 365 天的脑钠肽前体 N 端（NT-proBNP）水平；24 小时 Holter 监测 24 小时、91 天和 365 天的心律失常发生率；365 天的全因死亡或再住院率；365 天的心血管死亡或再住院率。
机构审查委员会批准了这项临床试验，该试验将符合《赫尔辛基宣言》。所有患者都将提供知情同意。对于没有其他治疗选择的患者来说，它可能提供了一种新颖、有效和技术简单的技术。研究结果将提交给索引医学期刊以及国内外会议。
ClinicalTrials.gov：NCT02798276，预注册结果。
