UnknownPhase 1/2

Mesenchymal Stem Cells for Idiopathic Dilated Cardiomyopathy

Spain70 participantsStarted 2013-03

Plain-language summary

The purpose of this study is to assess the safety, the feasibility and the efficacy of transendocardial injection of bone marrow-derived mesenchymal stem cells (MSCs) in patients with dilated idiopathic cardiomyopathy.

Who can participate

Age range

18 Years – 80 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: * II-III NYHA functional class, under optimal medical therapy. * LVEF ≥ 20% and ≤ 45% by echocardiography, SPECT or left ventriculogram one month prior to enrollment. * Anterior wall thickness ≥ 8 mm by echocardiography or MRI one month prior to enrollment. * Idiopathic DCM diagnosis (having excluded CAD, valvular heart disease, cardiac toxic drugs, tachyarrhythmias, metabolic diseases, systemic diseases, infectious diseases) six months prior to enrollment. * Patients rejected for heart transplantation should have been discussed in the Heart Team at their respective centres, and a document stating the reason for exclusion will be kept in the medical record. * Able to exercise on a treadmill, MVO2 between ≥ 12 and ≤ 21 ml/Kg/min. * Hemodynamic stability (blood pressure \> 100/40 mmHg, heart rate \< 110 bpm and oxygen saturation \> 95%). * Negative pregnancy test in women. * Signed informed consent Exclusion Criteria: * Evidence of secondary dilated cardiomyopathy causes: CAD, valvular heart disease, cardiac toxic drugs, tachyarrhythmias, metabolic diseases, systemic diseases, infectious diseases, myocarditis or postpartum ventricular dysfunction. * Permanent atrial fibrillation. * Candidates for ICD or CRT devices. Patients with theses devices can be enrolled if the device has been implanted at least 6 months before inclusion, and only if no-response has been observed to CRT. * Candidates for heart transplantation if surgery is anticipated in the next 2 …

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

Major adverse cardiac adverse events. SAEs and AEs.

Timeframe: change from enrollment( 1, 3, 6, 12, 18 and 24 months)

NYHA functional class.

Timeframe: Change from enrolment( 1, 3, 6, 12, 18, 24 months)

Incidence of complications with the use of NOGA XPTM catheters.

Timeframe: Change from enrolment( 1, 3, 6, 12, 18, 24 months)

Laboratory parameters including C-reactive protein an brain natriuretic peptide

Timeframe: Change from enrolment( 1, 3, 6, 12, 18, 24 months)

Trial details

NCT IDNCT01957826

SponsorHospital General Universitario Gregorio Marañon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03

Contact for this trial

Ricardo Sanz, MD

034 91 426 5882 rsanzruiz@hotmail.com

View on ClinicalTrials.gov More Primary Idiopathic Dilated Cardiomyopathy trials

Who can participate

Age range

18 Years – 80 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.

What they're measuring

Major adverse cardiac adverse events. SAEs and AEs.

Timeframe: change from enrollment( 1, 3, 6, 12, 18 and 24 months)

NYHA functional class.

Timeframe: Change from enrolment( 1, 3, 6, 12, 18, 24 months)

Incidence of complications with the use of NOGA XPTM catheters.

Timeframe: Change from enrolment( 1, 3, 6, 12, 18, 24 months)

Laboratory parameters including C-reactive protein an brain natriuretic peptide

Timeframe: Change from enrolment( 1, 3, 6, 12, 18, 24 months)