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NCT00235417 Clinical Trial

Stem Cell Therapy in Chronic Ischemic Heart Failure

Myocardial Ischemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00235417
Other study ID # Stem cell
Secondary ID
Status Completed
Phase Phase 2
First received October 6, 2005
Last updated June 7, 2007
Start date October 2005
Est. completion date May 2007

Study information
Verified date June 2007
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Bone marrow transplantation

Locations
Country Name City State
Denmark Department of Cardiology, Odense University Hospital Odense Odense C

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
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