Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 19
- 主要终点
- Number of Temporary Weans From LVAD Support Tolerated
研究概览
简要总结
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.
详细描述
Intramyocardial injection of mesenchymal precursor cells (MPC) in patients with advanced heart failure who are treated with left ventricular assist device (LVAD) implantation may result in a renewable source of proliferating functional cardiomyocytes; induce development of capillaries and larger-size blood vessels to supply oxygen and nutrients to endogenous myocardium and newly-implanted cardiomyocytes; and release factors capable of paracrine signaling.
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)
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
- •Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
- •Age 18 years or older
- •If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure
- •Female subjects of childbearing potential must have a negative serum pregnancy test at screening
- •Admitted to the clinical center at the time of randomization
- •Clinical indication and accepted candidate for implantation of an FDA-approved (US sites only) or Health Canada-approved (Canadian sites only) implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.
排除标准
- •Planned percutaneous LVAD implantation
- •Anticipated requirement for biventricular mechanical support
- •Concomitant arrhythmia ablation at time of LVAD implantation
- •- Planned aortic valve intervention for aortic insufficiency at the time of LVAD implantation
- •Cardiothoracic surgery within 30 days prior to randomization
- •Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as unstable plaque rupture, erosion or dissection within 30 days prior to randomization
- •Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty
- •Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism)
- •Stroke within 30 days prior to randomization
- •Platelet count < 100,000/ul within 24 hours prior to randomization
- •Acute infectious process: acute bacterial, fungal, or viral disease OR acute exacerbation of chronic infectious disease such as hepatitis
- •Presence of >10% anti-HLA antibody titers with known specificity to MPC donor HLA antigens
- •A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products
- •History of a known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated
- •Presence of human immunodeficiency virus (HIV)
- •Received investigational intervention within 30 days prior to randomization
- •Treatment and/or an incomplete follow-up treatment of any investigational cell based therapy within 6 months prior to randomization
- •Active participation in other research therapy for cardiovascular repair/regeneration
- •Prior recipient of stem precursor cell therapy for cardiac repair
- •Pregnant or breastfeeding at time of randomization.
- •History of known or suspected hypercoagulable state in the opinion of the investigator
研究组 & 干预措施
MPC Intramyocardial Injection
Intramyocardial injections of 150 million MPCs
干预措施: MPC Intramyocardial Injection (Biological)
Control Solution
Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
干预措施: Control Solution (Drug)
结局指标
主要结局
Number of Temporary Weans From LVAD Support Tolerated
时间窗: up to 6 months
functional status, defined by the number of temporary weans from LVAD support tolerated over the 6 months post-randomization. A successful wean is the ability to tolerate temporary weaning from LVAD support for 30 minutes without sustained symptoms of worsening heart failure. Wean failures are defined as inability to tolerate the temporary wean for 30 minutes; death; or patient too unstable, in the judgment of the primary heart failure cardiologist, to tolerate the wean attempt.
Number of Participants With Adverse Events
时间窗: up to 6 months
Safety as assessed by number of study intervention-related adverse events
次要结局
- Physiologic Assessments(up to 12 months)
- Functional Status(up to 12 months)
- MCG Complex Figures(3 months and 12 months)
- Digit Span(3 months and 12 months)
- Digit Symbol Substitution Test(3 months and 12 months)
- Change in Quality of Life (QoL)(6 months and 12 months)
- Controlled Oral Word Association(3 months and 12 months)
- Overall Survival(up to 12 months)
- Histopathological Assessments of Myocardial Tissue(up to 12 months)
- Hopkins Verbal Learning Test(3 months and 12 months)
- Trailmaking Tests A and B(3 months and 12 months)
- Hospital Costs(up to 12 months)
- Length of Stay(up to 12 months)
- Hospitalizations(up to 12 months)
研究者
Annetine Gelijns
Chair, Department of Population Health Science & Policy; Edmond A. Guggenheim Professor of Health Policy; Co-Director, InCHOIR
Icahn School of Medicine at Mount Sinai