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Completed

NCT Number: NCT00235417

Stem Cell Therapy in Chronic Ischemic Heart Failure

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Cardiology, Odense University Hospital

Odense, Odense C, DK-5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Bone Marrow Transplantation

Procedure

Primary outcomes

  1. Changes in left ventricular ejection fraction from baseline to 12 months' follow-up

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
Oct 10, 2005
Registry last updated
Jun 8, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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