NCT03572660进行中（未招募）2 期
Phase II Study Assessing the Combined Use of Autologous Bone Marrow Derived Mononuclear Cells and G-csf With Percutaneous Circulatory Assistance in the Treatment of Dilated Cardiomyopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in left ventricular ejection fraction
研究概览
简要总结
DCM Support is recruiting patients with dilated cardiomyopathy and heart failure symptoms. The goal of this clinical trial is to examine whether treatment with a patient's own stem cells can improve their heart function and alleviate heart failure symptoms.
- Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic.
- The stem cells will be infused into the arteries that supply blood to the heart under local anaesthetic.
- A mini heart pump will be used to take the strain off the heart during the procedure.
- The follow-up involves a phone call at 1 month and clinic visits at 3 and 12 months
详细描述
DCM SUPPORT is a single centre, single arm clinical trial taking place at St Bartholomew's Hospital in London, UK.
- It is recruiting patients with dilated cardiomyopathy and ongoing heart failure symptoms
- All patients undergo a bone marrow aspiration after 5 days of subcutaneous G-CSF injections
- After cell processing, bone marrow-derived mononuclear cells are infused into the coronary arteries using the stop-flow technique. An intra-procedural Impella CP device is used to support the circulation.
- The primary endpoint is change in left ventricular ejection fraction at 3 months as measured by cardiac CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of dilated cardiomyopathy under the supervision of a physician or a heart failure nurse specialist.
- •NYHA class ≥ 2 symptoms despite having received optimal medical therapy and appropriate device therapy, as per clinical guidelines for an interval of at least 3 months.
- •No other treatment options available as part of the current best standard of care.
- •LVEF ≤35% on any imaging modality performed as part of the screening phase.
排除标准
- •Congenital heart disease.
- •Clinically significant valvular heart disease.
- •Patients who are not suitable for a Percutaneous Mechanical Support Device (E.g. unsuitable femoral artery anatomy, unable able to lie flat for prolonged time to accommodate the stem cell infusion & presence of LV thrombus)
- •Weight of patient that exceeds the maximum limit of the cardiac catheterisation laboratory table / CT scanner.
- •Cardiomyopathy 2o to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity & chronic uncontrolled tachycardia.
- •Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.
- •Previous cardiac surgery.
- •Contra-indication for bone marrow aspiration (thrombocytopaenia - platelet count <80 x 10(9)/L or extensive surgical scarring/anatomical deformity at site of bone marrow puncture).
- •Known active infection on admission as defined by a temperature >37.5°C or on a short course of antibiotics.
- •An active infection of hepatitis B, hepatitis C, syphilis or HTLV
- •Known HIV infection
- •Chronic inflammatory disease requiring on-going medication.
- •Concomitant disease with a life expectancy of less than one year
- •Follow-up impossible (no fixed abode, etc.)
- •Neoplastic disease without documented remission within the past 5 years.
- •Patients on renal replacement therapy.
- •Subjects of childbearing potential unless βHCG negative and are on adequate contraception during the trial.
- •Patients falling into the vulnerable category or lacking capacity
- •Patients who are unable to understand or read written English will be excluded from the trial.
- •Killip Class III or above
研究组 & 干预措施
BMMNC intervention arm
Other
Bone marrow derived mononuclear cells and G-CSF
干预措施: Bone marrow derived mononuclear cells and G-CSF (Biological)
结局指标
主要结局
Change in left ventricular ejection fraction
时间窗: Baseline to 3 months
Change in left ventricular ejection fraction as measured by cardiac CT
次要结局
- Change in biochemical markers of heart failure(Baseline to 3 and 12 months)
- Assessment of rates of stroke(3 and 12 months)
- Change in left ventricular ejection fraction(Baseline to 12 months)
- Change in heart failure symptoms(Baseline to 3 and 12 months)
- Change in quality of life as assessed by Minnesota Living with Heart Failure Questionnaire scores(Baseline to 3 and 12 months)
- Procedural safety as assessed by in-hospital procedural related morbidity/mortality(In-hospital procedural time)
- Assessment of peri-procedural myocardial infarction(Day 0 and Day 6)
- Change in inflammatory markers(Baseline to 3 and 12 months)
- Assessment of rates of MACE (cumulative & individual components)(3 and 12 months)
- Change in exercise capacity(Baseline to 3 and 12 months)
- Change in quality of life as measured by EuroQol-5 Dimension 5 Levels questionnaires(Baseline to 3 and 12 months)
- Change in renal function(Baseline to 3 and 12 months)
研究者
研究点 (1)
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