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Clinical trial to evaluate the efficacy of intracoronary infusion of autologous bone marrow mononuclear in patients with dilated cardiomyopathy.
EU CTIS ID: 2024-516594-71-01
What this study is testing
To evaluate the efficacy of intracoronary injection of autologous bone marrow mononucleated cells (BMMNCs) in improving ventricular function among patients with idiopathic dilated cardiomyopathy, for which there is currently no effective therapeutic alternative.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of both sexes, aged between 18 and 70 years.
- Women of childbearing age must obtain a negative pregnancy test at the time of inclusion in the study and agree to use a medically approved method of contraception while on study. Effective contraceptive method is defined as hormonal methods that inhibit ovulation (which combine estrogen with progestogen, or only progestogen) oral, transdermal, intravaginal, injectable or implantable, IUD, surgical sterilization or total abstinence.
- MD patients diagnosed with idiopathic established by echocardiography.
- Minimum evolution from diagnosis of 6 months.
- Absence of coronary lesions tested with multislice CT and / or hemodynamic study, obtained after patient inclusion, or 36 months before patient inclusion, provided that the patient has not presented anginal symptoms. In certain clinical profiles with very low risk of presenting coronary lesions, in order to avoid the risks of an invasive intervention or the use of ionizing radiation, the verification of this criterion can be based on tests performed within a longer period.
- Patients with stable medical therapy for at least 6 months prior to enrollment (individually adjusted according to functional degree).
You likely can't join if
- Dilated Cardiomyopathy Secondary.
- Positive serology for HBV, HCV or HIV.
- Patients at the time of study entry are taking any medications prohibited by the protocol. A “washout period” 2 months to be included in the trial is set.
- Recent history of myocarditis in the 6 months prior to signing the informed consent.
- Patients amenable to treatment with resynchronization. Those are patients with IC who have a QRS > 150, present symptoms and do not respond to drug treatment. Patients who have undergone a resynchronization within 6 months prior to inclusion, and who have not responded to it (have not changed the ejection fraction) is not excluded.
- Patients in active waiting list for heart transplantation.
See the full eligibility criteria
Who can join
- Patients of both sexes, aged between 18 and 70 years.
- Women of childbearing age must obtain a negative pregnancy test at the time of inclusion in the study and agree to use a medically approved method of contraception while on study. Effective contraceptive method is defined as hormonal methods that inhibit ovulation (which combine estrogen with progestogen, or only progestogen) oral, transdermal, intravaginal, injectable or implantable, IUD, surgical sterilization or total abstinence.
- MD patients diagnosed with idiopathic established by echocardiography.
- Minimum evolution from diagnosis of 6 months.
- Absence of coronary lesions tested with multislice CT and / or hemodynamic study, obtained after patient inclusion, or 36 months before patient inclusion, provided that the patient has not presented anginal symptoms. In certain clinical profiles with very low risk of presenting coronary lesions, in order to avoid the risks of an invasive intervention or the use of ionizing radiation, the verification of this criterion can be based on tests performed within a longer period.
- Patients with stable medical therapy for at least 6 months prior to enrollment (individually adjusted according to functional degree).
- LVEF <40 % or LVEF 40 % -50 % if LVEDV > 110 ml/m2 measured by echocardiogram.
- Presence of sinus rhythm.
- Patients give their informed consent for participation in the clinical trial.
- Normal laboratory parameters, defined by: WBC > 3000, Neutrophils >1500, Platelets > 100,000, AST / ALT < 2.5 standard range institution Creatinine < 2.5 mg / dl and Hemoglobin > 9 g/dl.
What rules you out
- Dilated Cardiomyopathy Secondary.
- Positive serology for HBV, HCV or HIV.
- Patients at the time of study entry are taking any medications prohibited by the protocol. A “washout period” 2 months to be included in the trial is set.
- Recent history of myocarditis in the 6 months prior to signing the informed consent.
- Patients amenable to treatment with resynchronization. Those are patients with IC who have a QRS > 150, present symptoms and do not respond to drug treatment. Patients who have undergone a resynchronization within 6 months prior to inclusion, and who have not responded to it (have not changed the ejection fraction) is not excluded.
- Patients in active waiting list for heart transplantation.
- Coexistence of other serious systemic diseases.
- Coexistence of any blood disease.
- Pregnant women, lactating, or of childbearing age not using effective contraception.
- Patients who are currently participating or have completed their participation in a clinical trial in less than 3 months or have participated in a clinical trial for Advanced Therapies (cell therapy, gene therapy or tissue engineering) at any time prior.
- Patients with malignant or pre-malignant tumors.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.