NCT04776239已完成1 期
Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- EPC-CFU levels
研究概览
简要总结
The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be ≥ 18 years of age (males and females).
- •Provide written informed consent.
- •Have a diagnosis of symptomatic ischemic heart disease (IHD) and an indication for standard-of-care coronary angiography.
- •Have Diabetes Mellitus (DM) type 2 documented by glycated hemoglobin (HbA1C) > 7%, or on medical therapy for diabetes.
排除标准
- •Be younger than 18 years of age.
- •Have history of prior myocardial Infarction and revascularization.
- •Have a baseline glomerular filtration rate (GFR) <30 ml/min 1.73m2 estimated using the Modification of Diet for Renal Disease (MDRD) formula.
- •Have poorly controlled blood glucose levels with hemoglobin A1C > 8.5% in the previous 3 months.
- •Have a history of proliferative retinopathy or severe neuropathy requiring medical treatment.
- •Have an indication for standard-of-care surgical (including valve surgery, placement of left-ventricular assist device) or percutaneous intervention for the treatment of valvular heart disease (including valvuloplasty).
- •Have known hypersensitivity or contraindication to aspirin; both heparin and bivalirudin; all available P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor); or any zotarolimus, cobalt, chromium, nickel, tungsten, acrylic, or fluoropolymers; or hypersensitivity to contrast media that cannot be adequately premedicated.
- •Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/microliter (uL) or platelet values < 100,000/uL without another explanation (per investigator discretion).
- •Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the upper limit of normal.
- •Have a bleeding diathesis or coagulopathy (INR > 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions.
- •Be an organ transplant recipient or have a history of organ or cell transplant rejection.
- •Have a clinical history of malignancy within the past 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), except curatively-treated basal cell or squamous cell carcinoma, or cervical carcinoma.
- •Have a condition that limits lifespan to < 1 year.
- •Have a history of drug or alcohol abuse within the past 24 months.
- •Be serum positive for HIV, hepatitis B surface antigen (sAg), or viremic hepatitis C.
- •Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- •Be pregnant, nursing, or of childbearing potential and not on contraceptive medications. (May participate if on 2 forms of contraceptives).
- •Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up.
- •Coronary lesions with restenosis or heavy calcification.
研究组 & 干预措施
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
Experimental
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
干预措施: 100 million Allogeneic Mesenchymal Human Stem Cells (Drug)
Group B: Placebo Group
Placebo Comparator
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
干预措施: Placebo (Other)
结局指标
主要结局
EPC-CFU levels
时间窗: 6 months post-infusion
Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples. The unit of measure is the average number of colonies per well.
Flow Mediated Diameter Percentage (FMD%)
时间窗: 6 months post-infusion
FMD% is measured via brachial artery ultrasound. The unit of measure is percent.
Brachial Artery Flow Mediated Diameter Percentage (FMD%)
时间窗: Baseline, Week 2, Month 1, Month 3, and Month 6
FMD% is measured via brachial artery ultrasound. The unit of measure is percent.
EPC-CFU Counts
时间窗: Baseline, Week 2, Month 1, Month 3, and Month 6
Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples. The unit of measure is the average number of colonies per well.
次要结局
- Target lesion lumen loss(6 months (post-infusion))
- Circulating angiogenic factors marker levels(6 months post-infusion)
- Circulating inflammatory markers(6 months post-infusion)
- Seattle Angina Questionnaire (SAQ) Angina Frequency(6 months post-infusion)
- EuroQol 5 Dimension (EQ-5D) Quality of life Questionnaire Overall Health Status Question(6 months post-infusion)
- Short Form (SF) 36 Questionnaire Quality of Life Questionnaire(6 months post-infusion)
- Number of Treatment-Emergent Serious Adverse Events (TE-SAE)(1 month post infusion)
- Number of Major Adverse Cardiac Events (MACE)(12 months)
- Number of Treatment Emergent Adverse Events(12 months)
- Number of participants with abnormal lab values(12 months)
- Number of participants with Target Vessel Failure(12 months)
- Post-Percutaneous Coronary Intervention (PCI) coronary artery endothelial function as assessed via CFR(6 months (post-infusion))
- Post-PCI coronary artery endothelial function as assessed via FFR(6 months (post infusion))
- Fractional Flow Reserve (FFR)(Baseline, Month 6)
- Coronary Flow Reserve (CFR)(Baseline, Month 6)
- Seattle Angina Questionnaire (SAQ) Angina Frequency (AF)(Baseline, Week 2, Month 1, Month 3, and Month 6)
- Seattle Angina Questionnaire (SAQ) Quality of Life (QL)(Baseline, Week 2, Month 1, Month 3, and Month 6)
- Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)(1 month post infusion)
- Number of Participants With Major Adverse Cardiac Events (MACE)(12 months)
- Number of Participants With Target Vessel Failure(12 months)
- Number of Participants With Treatment Emergent Adverse Events(12 months)
- Number of Participants With Abnormal Lab Values(12 months)
- Circulating Angiogenic Marker - VEGF(Baseline, Month 1, Month 3, Month 6)
- Circulating Cytokine Biomarker - TNFα(Baseline, Month 1, Month 3, Month 6)
研究者
Joshua M Hare
Professor of Clinical Medicine
University of Miami
研究点 (2)
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