EUCTR2016-004662-25-PL进行中（未招募）1 期
Regeneration of ischemic damages in cardiovascular system using Wharton’s jelly as an unlimited source of mesenchymal stem cells for regenerative medicine.Project of the National Centre for Research and Development (Poland) ‘STRATEGMED II’.Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in patients with acute myocardial infarction (AMI). - CardioCell evaluation in AMI
Krakowski Szpital Specjalistyczny im. Jana Pawla II0 个研究点目标入组 115 人开始时间: 2017年9月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 115
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Acute myocardial infarction successfully treated by infarct related artery (IRA) successful revascularization
- •- Male and female patients, aged 18-80 years
- •- Large myocardial injury as demonstrated by LVEF =45% and/or infarct size (IS) =10% of the LV muscle on cMRI 2-5 days after pPCI
- •- Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 115
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 115
排除标准
- •- Pacemaker or other contraindications to cardiac MRI
- •- Malignancy
- •- Moderate or severe immunodeficiency
- •- Acute or chronic bacterial or viral infectious disease
- •- Soft tissue disease or local infection in a place of required artery puncture
- •- Pregnancy or breastfeeding
- •- Any objective or subjective reason for inability to attend follow-up visits
- •- Females of childbearing potential, who does not want to use a highly effective method of contraception
- •- Females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test
- •- Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient’s participation in this project
- •- Life expectancy < 1 year
- •- Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
研究者
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