Stem Cell Therapy in Chronic Ischemic Heart Failure

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00235417

Enrollment

Registered

2005-10-10

Start date

2005-10-31

Completion date

2007-05-31

Last updated

2007-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive, Myocardial Ischemia

Keywords

Bone Marrow Transplantation

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.

Interventions

PROCEDUREBone marrow transplantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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)

Design outcomes

Primary

Measure	Time frame
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026