Infusion Intracoronary of Mononuclear Autologous Adult no Expanded Stem Cells of Bone Marrow on F… (NCT02033278) | Clinical Trial Compass
TerminatedPhase 2
Infusion Intracoronary of Mononuclear Autologous Adult no Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.
Stopped: Low recruitment rate, bibliographic evidence of lack of efficacy
Spain27 participantsStarted 2014-01-06
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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/m2.
✓. Presence of sinus rhythm.
✓. Writen informed consent for participation in the trial.
Exclusion criteria
✕
What they're measuring
1
Changes in ventricular function measured angiographically.
Timeframe: 24 months
Trial details
NCT IDNCT02033278
SponsorAndalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
✕. 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.