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Study on the Effectiveness of Autologous Bone Marrow Cells for Patients with Dilated Cardiomyopathy and Heart Failure

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a heart condition known as idiopathic dilated cardiomyopathy, which is a type of heart failure where the heart becomes enlarged and cannot pump blood efficiently. The trial is testing a new treatment involving the use of autologous bone marrow-derived adult mononuclear cells. These are special cells taken from a patient's own bone marrow and are not expanded or grown in a lab before being injected back into the patient. The treatment is given through a method called intracoronary infusion, which means the cells are delivered directly into the heart's blood vessels.

The purpose of the study is to see if this treatment can help improve heart function in patients with this condition, for which there are currently no effective treatments. Participants in the study will receive either the cell treatment or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will undergo various assessments to monitor changes in their heart function and overall health. These assessments include clinical evaluations, heart imaging tests, and exercise tests. The study aims to determine if the treatment can lead to better heart function and fewer heart-related problems over time. Participants will be closely monitored with regular check-ups and follow-ups to ensure their safety and to gather comprehensive data on the treatment's effectiveness.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.
A negative pregnancy test is required for women of childbearing age, along with agreement to use a medically approved method of contraception during the study.
Step 2
Initial assessment
An initial assessment is conducted, including a full echocardiogram to measure heart function and ensure the absence of coronary lesions.
Laboratory tests are performed to confirm normal blood parameters.
Step 3
Treatment administration
The treatment involves the intracoronary infusion of autologous bone marrow-derived adult mononuclear cells.
This procedure is performed to evaluate its efficacy in improving heart function in patients with dilated cardiomyopathy.
Step 4
Monitoring and follow-up
Regular follow-up appointments are scheduled to monitor changes in heart function and overall health.
These include clinical evaluations, echocardiograms, and exercise tests to assess functional capacity.
Step 5
Safety and efficacy evaluation
The study evaluates the safety of the treatment by monitoring for any adverse events.
Efficacy is assessed through changes in heart function and the absence of major cardiac events during follow-up.
Step 6
Completion of the study
The study is expected to conclude by September 2025.
Final assessments are conducted to determine the overall impact of the treatment on heart function and patient health.

Who can join the trial?

10 criteria

Patients of both sexes, aged between 18 and 70 years.
Women of childbearing age must have a negative pregnancy test at the start of the study and agree to use a medically approved method of birth control during the study. This includes methods like birth control pills, patches, vaginal rings, injections, implants, IUDs, surgical sterilization, or total abstinence.
Patients diagnosed with **idiopathic dilated cardiomyopathy** confirmed by an **echocardiogram**. An echocardiogram is a test that uses sound waves to create pictures of the heart.
The condition must have been diagnosed at least 6 months ago.
No signs of **coronary lesions** as shown by a **multislice CT** or a **hemodynamic study**. These are tests to check for blockages in the heart's blood vessels. The tests should be done after joining the study or within 36 months before joining, as long as there have been no chest pain symptoms.
Patients must have been on stable medical treatment for at least 6 months before joining the study. This treatment is adjusted based on how well the patient is functioning.
**LVEF** (Left Ventricular Ejection Fraction) must be less than 40%, or between 40% and 50% if **LVEDV** (Left Ventricular End-Diastolic Volume) is greater than 110 ml/m². These are measurements of how well the heart is pumping blood.
Presence of **sinus rhythm**, which means a normal heartbeat pattern.
Patients must agree to participate by giving their informed consent.
Normal laboratory test results, including: **WBC** (White Blood Cells) greater than 3000, **Neutrophils** greater than 1500, **Platelets** greater than 100,000, **AST/ALT** (liver enzymes) less than 2.5 times the normal range, **Creatinine** less than 2.5 mg/dl, and **Hemoglobin** greater than 9 g/dl.

Who cannot join the trial?

7 criteria

Patients with other types of heart disease, not just idiopathic dilated cardiomyopathy. This is a condition where the heart becomes enlarged and cannot pump blood effectively, and the cause is unknown.
Patients who have had a recent heart attack or other serious heart events.
Patients with severe kidney or liver disease.
Patients with active infections or serious illnesses that could affect the study results.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who are unable to give informed consent, meaning they cannot understand the study and agree to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital Costa del Sol
Marbella, Spain
Verified
Hospital Jerez de la Frontera
Jerez De La Frontera, Spain
Verified
Virgen del Rocío University Hospital
Sevilla, Spain

Trial locations

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Investigated drugs

Autologous Bone Marrow Mononucleated Cells (BMMNCs) are cells taken from a patient's own bone marrow. In this trial, these cells are injected directly into the coronary arteries. The goal is to see if these cells can help improve heart function in patients who have a type of heart disease called idiopathic dilated cardiomyopathy, which currently has no effective treatment options.

Autologous Bone Marrow-Derived Adult Mononuclear Cells, Not Expanded

What is already known about the treatment

Autologous Bone Marrow Mononucleated Cells (BMMNCs) – This treatment involves the intracoronary infusion of cells derived from a patient's own bone marrow. It is currently being studied in clinical trials, specifically for its potential to improve heart function in patients with idiopathic dilated cardiomyopathy, a condition where the heart becomes weakened and enlarged. The main therapeutic indication is to enhance ventricular function in these patients. The mechanism of action involves the cells potentially aiding in the repair and regeneration of heart tissue, although the exact molecular processes are still under investigation. This treatment falls under the category of regenerative medicine, focusing on using the body's own cells to heal damaged tissues.

Investigated diseases

Idiopathic Dilated Cardiomyopathy – This is a condition where the heart becomes enlarged and weakened, affecting its ability to pump blood efficiently. The term "idiopathic" indicates that the exact cause of the disease is unknown. Over time, the heart's chambers, particularly the ventricles, dilate and the heart muscle thins, leading to reduced cardiac output. This can result in symptoms such as fatigue, shortness of breath, and swelling in the legs and ankles. The progression of the disease can vary, with some individuals experiencing a gradual worsening of symptoms. It is a chronic condition that requires ongoing management to monitor heart function and symptoms.