Stem Cell Therapy in Chronic Ischemic Heart Failure

Phase 2

Completed

• Conditions: Myocardial Ischemia; Heart Failure, Congestive

• Registration Number: NCT00235417
• Lead Sponsor: Odense University Hospital

Brief Summary

The purpose of this study is to determine whether intracoronary bone marrow transplantation can improve left ventricular ejection fraction in patients with severe ischemic heart failure and no other option for standard therapies (revascularization and drugs).

Detailed Description

Despite standard therapies (revascularization and drugs), patients with severe ischemic heart failure have a high morbidity and mortality.

The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with severe ischemic heart failure.

35 patients with stable left ventricle function will - with four months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories. Echocardiography is performed three times prior (four and two months and just before) and two times after (four and eight months after) therapy. It is a non-randomised trial, patients will enter as their own control.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-06
• Study First Posted: 2005-10-10
• Study Completion: 2007-05
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-07
• Last Update Posted: 2007-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Severe ischemic heart failure and no other other option for standard therapies (revascularization and drugs),
2. Stable left ventricular ejection fraction < 40%,
3. CCS class 2-3 and/or NYHA class 2-3, and
4. Signed informed consent.

Read More

Exclusion Criteria

1. Implantation of pacemaker (including implantable cardioverter defibrillator [ICD] and biventricular pacing),
2. Acute myocardial infarction within 3 months,
3. Atrial fibrillation, or
4. Severe comorbidity that could impact the patient's short-term survival (including primary hematologic disorders)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up

Trial Locations

Locations (1)

Department of Cardiology, Odense University Hospital; 🇩🇰 Odense, Odense C, Denmark