Multicenter Phase IIb Clinical Trial, Double-blind, Randomized, Controlled Placebo for to Assess the Efficacy of Intracoronary Infusion of Autologous Adult Stem Cells Mononuclear Marrow Unexpanded on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 9
- 主要终点
- Changes in ventricular function measured angiographically.
研究概览
简要总结
Clinical trial phase IIb, double-blind, randomized, controlled with placebo. There is sufficient preliminary evidence to consider intracoronary injection of bone marrow progenitor cells as a viable, safe and beneficial treatment in patients with dilated cardiomyopathy, although the biological mechanism of action of bone marrow cells in the myocardium is not known. In this project we propose to investigate comparatively and from a biological and clinical point of view the applicability of regenerative therapy with autologous bone marrow cells in patients with dilated cardiomyopathy.
详细描述
The study population correspond to male and female patients with idiopathic dilated cardiomyopathy.
51 patients diagnosed with this disease are included. After inclusion, will proceed to the random allocation to study group or control group in a 2:1 ratio, 34 patients in the treatment group and 17 in the control group.
The total duration is expected to be 48 months: The inclusion period is 24 months and each patient assigned to the experimental group will be followed for 24 months, whereas that one ramdomized to the control group, will have a folow-up of 12 months. Upon completion there of, the patients will be followed in routine clinical practice.
This is a double blind study, in which all patients will perform the bone marrow harvesting.
All patients will receive the best medical treatment individualized (ACEIs or Angiotensin II receptor blocker, beta-blockers, diuretics and eplerenone) for at least 6 months prior to their participation in the clinical trial, so that the situation is stable and pharmacological basal condition is the same for everyone.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes and ages between 18 and 70 years.
- •Patients diagnosed with dilated cardiomyopathy established by echocardiography.
- •Minimum evolution since diagnosis of 6 months.
- •Absence of coronary injury tested with multislice CT and/or hemodynamic study performed after study entry, or within the previous 36 months (or before in specific low risk clinical profiles) if no angina symptomatology is present.
- •Patients receiving optimized medical therapy for at least 6 months prior to enrollment (individually adjusted according to functional status).
- •Ejection fraction of the left ventricle <40% or ejection fraction of the left ventricle 40% -50% if left ventricular tele-diastolic volume is > 110 ml/m
- •Presence of sinus rhythm.
- •Writen informed consent for participation in the trial.
- •Normal laboratory parameters, defined by: Leukocytes ≥ 3000; Neutrophils ≥ 1500; Platelets ≥ 100,000; Aspartate aminotransferase / Alanine aminotransferase ≤ 2.5 standard range institution; Creatinine ≤ 2.5 mg / dL; Haemoglobin > 9 g/dL
- •Women of childbearing potential must have negative results on a pregnancy test and agree to use medically approved methods of contraception thoughout follow up.
排除标准
- •Secondary Dilated cardiomyopathy.
- •Recent history of myocarditis (< 6 months prior to study entry).
- •Patients amenable to receive cardiac resynchronization therapy
- •Patients in active waiting list for heart transplantation.
- •Coexistence of other serious systemic diseases.
- •Coexistence of any type of blood disease
- •Pregnant or breastfeeding women; or women of childbearing potential not comminting to use effective contraception.
- •Patients who are currently participating, or have completed their participation in a clinical trial within the last 3 months. Patients who have participated in any advanced therapies clinical trial any time previously.
- •Patients with malignant or pre-malignant tumors.
- •Positive serology for hepatitis B virus, hepatitis C virus or human immunodeficiency virus.
- •Use of any protocolo prohibited medication. A wash-out period of 2 months can be considered for inclusion in the trial.
研究组 & 干预措施
Infusion of autologous mononuclear bone marrow cells
Infusion of autologous mononuclear bone marrow cells plus conventional medical treatment (as indicated by clinician)
干预措施: Infusion of autologous mononuclear bone marrow cells (Drug)
Placebo infusion
Placebo infusion plus conventional medical treatment (as indicated by clinician)
干预措施: Placebo infusion (Drug)
结局指标
主要结局
Changes in ventricular function measured angiographically.
时间窗: 24 months
次要结局
- Clinical and analytical progress (NYHA grade & BNP)(24 months)
- Degree of clinical improvement based on the absence of major cardiac events (MACE) during follow-up.(24 months)
- Time of evolution since diagnosis of idiopathic dilated cardiomyopathy prior to study entry.(24 months)
- Functional recovery as measured with ergometry(24 months)
- Echocardiography and Electrocardiography variables(24 months)