Randomized Controlled Single Blind Trial of Autologous Bone Marrow Mononuclear Cells Under Electromechanical Guidance for Therapeutic Angiogenesis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of Autologous-bone-marrow Injections
研究概览
简要总结
This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion criteria, and no exclusion criteria are found, the subject is consented for the study, and extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline testing criteria is met, the patient has their own bone marrow harvested and later that day the subject is taken to a cardiac catheterization lab where left ventricular electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed stem cells are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow up visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4, 5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits, including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell injection.
详细描述
This is a phase 1, single-blind trial to evaluate the use of autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections of autologous mononuclear bone marrow cells in patients with end-stage ischemic heart disease is safe, can promote neovascularization, and can improve perfusion and myocardial contractility. The primary object of this study will be to evaluate the safety of autologous-bone-marrow mononuclear cell injections. The secondary endpoint of the study is to assess the efficacy of autologous bone marrow cells in improving cardiac contractile function and functional outcome. The efficacy will be assessed on the basis of the treadmill Max VO2 (maximum volume oxygen uptake). Secondarily the efficacy will be assessed on the basis of clinical status and imaging rests, with follow-up extending to 1 year after enrollment.A maximum of 30 patients will be enrolled in the study. At the end of the 6-month visit. after the required angiogram with mapping and non-invasive testing is complete, the patients will be told whether they were in the control or the active group (stem cell therapy). Those in the control group will be told before final invasive testing, and those who consent may cross over to the active therapy arm and undergo the cell injection procedure (control, then stem cell therapy. In these patients, the foll-up angiogram and mapping procedure will also serve as the baseline procedure required for cell injection. Bone marrow mononuclear cells will be injected in an identical fashion, according to the same criteria described for the original treatment group, and these patients will have identical follow-up visits starting again at the baseline time-point and extending for up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LVEF less than 45%
- •Functional class III or IV angina
- •At least 7% reversibility by Single Photon Emission Computed Tomography (SPECT) nuclear study
- •there are additional inc. criteria
排除标准
- •AGe <18 or >70 years of age
- •Constant atrial fibrillation
- •Left ventricular (LV) thrombus
- •History of malignancy in the last 5 years
- •LV wall thickness of < 8 mm at the target site
- •there are additional exclusion criteria
结局指标
主要结局
Safety of Autologous-bone-marrow Injections
时间窗: up to 2 weeks post-procedure, 3 months and 6 months
Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF \[CHF\], acute coronary syndrome, myocardial infarction, stroke, or death).
次要结局
- Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope)(baseline and 3 months)
- New York Heart Association (NYHA)Classification(baseline, 3 months and 6 months)
- Echocardiography (EF)Percent (%)(baseline, 3 months and 6 months)
- Canadian Cardiovascular (CCS) Angina Score(baseline, 3 months and 6 months)
- Left Ventricular End-Systolic Volume (LVESV) (ml)(baseline, 3 months and 6 months)
- Linear Local Shortening (LLS)(baseline and 6 months)
- Myocardial Oxygen Consumption (MVO2)(baseline, 3 months and 6 months)
- Echocardiography Wall Motion Score Index (WMSI)(baseline and 3 months)
- Left Ventricular End-Diastolic Volume (LVEDV)(baseline, 3 months and 6 months)
- Endocardial Unipolar Voltages (UPV)(baseline and 6 months)
- Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%)(baseline, 3 months and 6 months)
- Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%)(baseline and 6 months)
研究者
Emerson Perin, MD, PhD
Director Clinical Research for Cardiovascular Medicine and Director Stem Cell Center
Texas Heart Institute