REGENERATE-COBRA:一项二期随机假对照试验,评估在难治性心绞痛患者中冠状动脉内注射自体骨髓衍生细胞的安全性和有效性。

IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2024-06-09 DOI:10.1016/j.ahj.2024.06.001
Rohini Ramaseshan MD , Dhanuka Perera MD , Alice Reid MA , Mervyn Andiapen RN , Cono Ariti PhD , Matthew Kelham MD , Daniel A. Jones MD PhD , Anthony Mathur MD PhD
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引用次数: 0

摘要

目的:REGENERATE-COBRA 试验(NCT05711849)将评估冠状动脉内输注自体骨髓源性单核细胞治疗难治性心绞痛患者的安全性和有效性:REGENERATE-COBRA是一项单点、盲法、随机、假对照的II期临床试验,共招募了110名没有血管再通选择的难治性心绞痛患者,这些患者在接受了最佳的药物和器械治疗后仍无症状。患者将随机接受自体骨髓单核细胞治疗或假性治疗。细胞治疗组患者将进行骨髓抽吸,并在冠状动脉内输注自体骨髓单核细胞。对照组患者将进行假骨髓抽吸和假冠状动脉内输注。试验的主要终点是加拿大心血管协会(CCS)心绞痛分级在基线和6个月之间提高2级。次要终点包括12个月时的CCS分级、6个月时的心肌缺血负荷(通过灌注成像测量)、6个月和12个月时的生活质量(通过EQ-5D-5L、EQ-5D-VAS和西雅图心绞痛问卷测量)、6个月和12个月时的心绞痛频率、总运动时间(通过改良布鲁斯方案测量)以及6个月和12个月时的主要心血管不良事件:这是首次评估冠状动脉内输注自体骨髓来源的未分离单核细胞对用尽常规治疗方案的无症状难治性心绞痛患者的安全性和有效性的试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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REGENERATE-COBRA: A phase II randomized sham-controlled trial assessing the safety and efficacy of intracoronary administration of autologous bone marrow-derived cells in patients with refractory angina

Aims

The REGENERATE-COBRA trial (NCT05711849) will assess the safety and efficacy of an intracoronary infusion of autologous bone marrow-derived mononuclear cells in refractory angina patients with no revascularization options who are symptomatic despite optimal medical and device therapy.

Methods

REGENERATE-COBRA is a single site, blinded, randomized, sham-controlled, Phase II clinical trial enrolling 110 refractory angina patients with no revascularization options who are symptomatic despite optimal medical and device therapy. Patients will be randomized to either autologous bone marrow derived-mononuclear cells or a sham procedure. Patients in the cell-treated arm will undergo a bone marrow aspiration and an intracoronary infusion of autologous bone marrow derived-mononuclear cells. Patients in the control arm will undergo a sham bone marrow aspiration and a sham intracoronary infusion. The trial's primary endpoint is an improvement in Canadian Cardiovascular Society (CCS) angina class by 2 classes between baseline and 6 months. Secondary endpoints include change in: CCS class at 12 months, myocardial ischemic burden (as measured by perfusion imaging) at 6 months, quality of life at 6 and 12 months (as measured by EQ-5D-5L, EQ-5D-VAS and Seattle Angina Questionnaire), angina frequency at 6 and 12 months, total exercise time (as measured by a modified Bruce protocol) and major adverse cardiovascular events at 6 and 12 months.

Conclusions

This is the first trial to assess the safety and efficacy of an intracoronary infusion of autologous bone marrow-derived unfractionated mononuclear cells in symptomatic refractory angina patients who have exhausted conventional therapeutic options.

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来源期刊
American heart journal
American heart journal 医学-心血管系统
CiteScore
8.20
自引率
2.10%
发文量
214
审稿时长
38 days
期刊介绍: The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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