Stem Cell Therapy in Chronic Ischemic Heart Failure

Odense University Hospital

Status and phase: Completed; Phase 2

Conditions: Myocardial Ischemia; Heart Failure, Congestive

Treatments: Procedure: Bone marrow transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00235417

Stem cell

Details and patient eligibility

About

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).

Full 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.

Enrollment: 35 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)