Bone marrow transplantation in Myocardial Ischemia and Heart Failure, Congestive - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Bone marrow transplantation

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 Type

Interventional

Enrollment (Anticipated)

35

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- Odense C
  - Odense, Odense C, Denmark, DK-5000
    - Department of Cardiology, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

Study Director: Per Thayssen, MDSci, Department of Cardiology, Odense University Hospital
Principal Investigator: Axel CP Diederichsen, phd, Department of Cardiology, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Diederichsen AC, Moller JE, Thayssen P, Videbaek L, Saekmose SG, Barington T, Kassem M. Changes in left ventricular filling patterns after repeated injection of autologous bone marrow cells in heart failure patients. Scand Cardiovasc J. 2010 Jun;44(3):139-45. doi: 10.3109/14017430903556294.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria