Clinical trial to evaluate the efficacy of intracoronary infusion of autologous bone marrow mononuclear in patients with dilated cardiomyopathy

Clinical trial phase III multicenter, double-blind, randomized, placebo-controlled trial evaluating the efficacy of intracoronary infusion of autologous adult stem mononuclear bone marrow unexpanded on functional recovery in patients with dilated cardiomyopathy and heart failure.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002015-98-ES

Enrollment

Registered

2013-07-12

Start date

2013-10-21

Completion date

Unknown

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dilated cardiomyopathy MedDRA version: 14.1 Level: PT Classification code 10007636 Term: Cardiomyopathy System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: LLT Classification code 10056419 Term: Dilated cardiomyopathy System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Células Mononucleares troncales adultas autólogas de médula ósea no expandidas Pharmaceutical Form: Solution for infusion INN or Proposed INN: células mononucleares troncales adultas aut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with dilated cardiomiophaty 2. Minimal evolution from the diagnosis of 6 months 3.Absence of coronary injuries. 4.Patients with pharmacological stable treatment for at least 6 months prior to enrollment. 5.FEVI 110 ml/m2. 6.Presence sinus rhythm. 7.Patients who have given they informed consent for participation in the clinical trial. 8.The women of childbearing potential must have a negative pregnancy test. 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 51 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 51

Exclusion criteria

Exclusion criteria: 1. Dilated cardiomyopathy of toxic origin, or ischemic diseases. 2. Recent history of myocarditis. 3. Patients suceptible of treatment with resynchronization 4. Patients in active waiting-list of cardiac Transplant 5. Coexistence of other systemic serious diseases. 6. Coexistence of any type of hematologic disease. 7. Pregnant women, Breast-Feeding, or in fertile age that they are not using a contraceptive effective method. 8. Patients with malignant or pre-malignant tumors. 9. Positive serology for HBV, HCV or HIV. 10. Patients who at the time of inclusion in the trial are taking any medications prohibited by the protocol. We define a "washout period" of two months in order to be included in the trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of intracoronary injection of autologous bone marrow progenitor, improving ventricular function in patients with idiopathic dilated cardiomyopathy.;Secondary Objective: To analyze the clinical, functional and biological predictors of good response to treatment with adult stem cells autologous mononuclear bone marrow expanded in terms of functional recovery.;Primary end point(s): 1 - Clinical evaluation and determination of NYHA functional class 2 - Determination of B-type natriuretic peptide 3 - Echocardiogram 4 - Evaluation of functional capacity. 7 - cardiac catheterization.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: To evaluate the efficacy of intracoronary injection of autologous bone marrow progenitor, improving ventricular function in patients with idiopathic dilated cardiomyopathy.;Secondary Objective: To analyze the clinical, functional and biological predictors of good response to treatment with adult stem cells autologous mononuclear bone marrow expanded in terms of functional recovery.;Primary end point(s): 1 - Clinical evaluation and determination of NYHA functional class 2 - Determination of B-type natriuretic peptide 3 - Echocardiogram 4 - Evaluation of functional capacity. 7 - cardiac catheterization.;Timepoint(s) of evaluation of this end point: 12 months

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Secondary

Measure	Time frame
Secondary end point(s): -The degree of clinical improvement based on the absence of major cardiac events (MACE) during follow-up. -The presence or absence of symptoms or arrhythmias during the first 12 months and clinical functional class. -Time of evolution from diagnosis of dilated cardiomiophaty to the enrrolment of the patient in the clinical trial;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Secondary end point(s): -The degree of clinical improvement based on the absence of major cardiac events (MACE) during follow-up. -The presence or absence of symptoms or arrhythmias during the first 12 months and clinical functional class. -Time of evolution from diagnosis of dilated cardiomiophaty to the enrrolment of the patient in the clinical trial;Timepoint(s) of evaluation of this end point: 12 months

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Countries

Spain

Contacts

Public ContactAna Cardesa Gil

Fundación Progreso y Salud

ana.cardesa@juntadeandalucia.es0034955019040NA

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 2, 2026