Clinical Trial Phase III single-center, open-label efficacy of intracoronary infusion of bone marrow mononuclear cells in patients with occlusion Autologous chronic coronary revascularization and ventricular dysfunction previously

FUNDACIÓN PROGRESO Y SALUD0 个研究点目标入组 60 人开始时间: 2013年4月9日最近更新: 2019年6月30日

试验速览

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•1. - Patients of both sexes with atherosclerotic coronary disease and chronic occlusions older than 3 months that has been achieved successful recanalization, medicated stents implanted, and where it persists despite ventricular dysfunction.
•2.-Age between 18 and 80 years.
•2. - The baseline ventricular function recanalization catheterization (performed approximately 3 months earlier) should be less than 45% ejection fraction.
•3. - In the magnetic resonance image performed at 3 months of recanalization, the ejection fraction of the patient should remain below 45%.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•1. - Patients with chronic occlusion recanalizadas not successful.
•2. - Patients with improvement of ejection fraction to values ??above 45% at 3 months after recanalization ..
•3. - Positive serology for HIV, HCV or HBV.
•4. - Coexistence of other serious systemic diseases or contraindications to dual antiplatelet therapy (clopidogrel and aspirin).
•5. - Coexistence of any blood disease.
•6. - Pregnant women, lactating, or of childbearing potential not using effective contraception.
•7. - Patients who are currently participating or have completed their participation in a clinical trial in a period of less than three months.
•8. - Patients with malignant or pre-malignant.
•9. - Patients who can not perform a magnetic resonance device being metallic carrier (prosthesis, defibrillators, pacemakers etc.).

发起方

FUNDACIÓN PROGRESO Y SALUD