Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions

Status Completed

Clinical Trial Summary

The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is limited by postinfarction left ventricular (LV) dysfunction.The purpose of this study is to determine whether intracoronary transfer of bone marrow cells will augment left ventricular function recovery of the heart.

Clinical Trial Description

Despite early coronary reperfusion, salvage of ischemic myocardium is incomplete and loss of viable myocardium initiates a process of adverse left ventricular (LV) remodeling1, compromising clinical outcome.

Experimental data have suggested that autologous bone marrow-derived or circulating progenitor cells may be beneficial for LV function recovery, but underlying mechanisms are unclear and prominent cardiomyocyte transdifferentiation has only been reported under selected experimental conditions. Early non-randomized clinical investigations indicate feasibility, safety and enhanced functional recovery after autologous human bone marrow-derived stem cell (BMSC) infusion into the infarct-related artery. More recently, a randomized open study demonstrated improvement of LV systolic function but not of LV remodeling following BMSC transfer.

In the absence of trials, in which the control group reproduces the exact conditions of the cell transfer group, including bone marrow aspiration and a placebo intracoronary injection, the true benefit of cell transfer cannot be fully appreciated.

We, therefore, designed a randomized, double-blind, and placebo-controlled exploratory study to investigate the effect of autologous BMSC transfer on LV functional and structural recovery after myocardial infarction. In view of the exploratory nature of the study and to detect potential mechanisms for the biological effect, we also assessed myocardial perfusion and oxidative metabolism using serial 1-[11C]acetate positron emission tomography (PET). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00264316
Study type	Interventional
Source	Universitaire Ziekenhuizen Leuven
Contact
Status	Completed
Phase	Phase 2
Start date	May 2003
Completion date	December 2005

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06013813` - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI	N/A
Completed	`NCT04507529` - Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients	N/A
Recruiting	`NCT06066970` - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting	`NCT03620266` - Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI	N/A
Completed	`NCT04097912` - Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
Completed	`NCT04153006` - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Completed	`NCT03668587` - Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
Recruiting	`NCT01218776` - International Survey of Acute Coronary Syndromes in Transitional Countries
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Recruiting	`NCT05371470` - Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation	N/A
Recruiting	`NCT04562272` - Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP	N/A
Completed	`NCT04584645` - A Digital Flu Intervention for People With Cardiovascular Conditions	N/A
Active, not recruiting	`NCT04475380` - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting	`NCT06007950` - Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health	N/A
Withdrawn	`NCT05327855` - Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)	Phase 2
Recruiting	`NCT02876952` - High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients	N/A
Completed	`NCT02711631` - Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation	N/A
Completed	`NCT02917213` - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed	`NCT02305602` - A Study of VentriGel in Post-MI Patients	Phase 1
Completed	`NCT02552407` - Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.