Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is compare the improvement in global and regional cardiac function measured by echocardiography and magnetic resonance in patients with old myocardial infarction subject to cardiac catheterisation with percutaneous endocavity implantation of autologous myoblasts.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment With Autologous Skeletal Myoblasts

NCT00975234

Old Myocardial Infarction

TERMINATED PHASE2

Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.

NCT01454323

Chronic Myocardial Ischemia

COMPLETED PHASE2

Efficacy Study of Intramuscular or Intracoronary Injection of Autologous Bone Marrow Cells to Treat Scarred Myocardium

NCT00560742

Myocardial Infarct Bone Marrow Cells

COMPLETED PHASE2

Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack.

NCT00102128

Ischemic Heart Failure Ischemic Heart Disease Ischemic Cardiomyopathy

TERMINATED PHASE2

Study to Assess the Efficacy and Safety of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Heart, Using an Catheter Delivery System

NCT00626314

Ischemic Cardiomyopathy

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. In the last few years, new treatments have been developed for the acute phase of myocardial infarction.We have managed to slow down disease progression with these new treatments, but it continues to the development of end stage heart failure. This study tries to determine the benefit of cell cardiomyoplasty with autologous myoblasts in patients with old MI.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Old Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Skeletal myoblasts

Percutaneous autologous myoblast implantation

Group Type EXPERIMENTAL

Percutaneous autologous myoblast implantation

Intervention Type PROCEDURE

Endocavity implantation of autologous myoblasts

No cells

Percutaneous culture medium without cells implantation

Group Type PLACEBO_COMPARATOR

Cardiac revascularization

Intervention Type PROCEDURE

Cardiac revascularization

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Percutaneous autologous myoblast implantation

Endocavity implantation of autologous myoblasts

Intervention Type PROCEDURE

Cardiac revascularization

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cellular therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with diagnosis of myocardial infarction, absence of viability.
* Ejection fraction under 40% or 45% in symptomatic patients
* Aged from 30-80 years old.
* Negative pregnancy test (women of childbearing age)
* Informed consent granted

Exclusion Criteria

* Prior history of tachycardia or ventricular fibrillation (except in the acute phase of MI).
* Myocardial infarction with more than 10 years of evolution.
* Patients positive for HIV, HBV or HCB.
* Patients with organ dysfunction: liver and kidney function
* History of cancer or prior treatment with chemotherapy.
* The patient should not suffer from any concomitant severe and/or uncontrolled medical condition.
* Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol.
* Pregnant or beast feeding women.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No