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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. Writen informed consent for participation in the trial.
Exclusion criteria
. 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.