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).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Reduction of infarct size
研究概览
简要总结
The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will be treated by the administration of placebo during the sham procedure.
详细描述
It is planned to enroll 105 patients into AMI trial with randomization into active (CardioCell) therapy and sham procedure/placebo administration with 2:1 ratio.
Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded fashion, labelled CardioCell to determine the early uptake and retention of IMP in the target ischemic tissues.
The primary research question of this project is to check if the administration of CardioCell could improve the clinical outcomes in patients with AMI. There are several secondary questions, defined by secondary endpoints, e.g.: if the investigated treatment is possible to administered, if the investigated treatment is safe and way of CardioCell administration, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The Data and Safety Monitoring Board (DSMB) will be blinded at project start, but may request unblinding if necessary to accommodate effective review of data.
Other than the DSMB (if necessary), the only other "un-blinded parties", meaning that they will have knowledge as to the patient's treatment assignment, will be the PBTiK UJ CM employee who participates in randomization utilizing randomization lists and investigational medication preparation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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
研究组 & 干预措施
Active Group
Patients randomized to the active treatment group will receive 30 000 000 WJMSCs suspended in 20mL 0.9% NaCl and 5% albumin administered via the IRA.
干预措施: Cardiac Drug (Drug)
Control Group
Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner.
干预措施: Placebos (Drug)
结局指标
主要结局
Reduction of infarct size
时间窗: Index hospitalization and in 6 month FU
Reduction of infarct size assessed in cardiac MRI during index hospitalization and in 6 month FU between two groups (active vs sham).
次要结局
- Infarct size reduction(6 month FU)
- Myocardial perfusion improvement(6 month FU)
- Increase of left ventricle ejection fraction (LVEF)(6 month FU)
- Left ventricle ejection fraction (LVEF) change against baseline.(6 month FU)
- Left ventricle end-systolic volume (ESV) change against baseline.(6 month FU)
- Left ventricle end-diastolic volume (EDV) change against baseline.(6 month FU)
- The occurrence of major adverse cardiovascular events(1 year FU)
- Quality of life improvement(6 month and 1 year FU.)