Stem Cell Therapy in Chronic Ischemic Heart Failure
Primary Purpose
Myocardial Ischemia, Heart Failure, Congestive
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Bone marrow transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring Bone Marrow Transplantation
Eligibility Criteria
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)
Sites / Locations
- Department of Cardiology, Odense University Hospital
Outcomes
Primary Outcome Measures
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
Secondary Outcome Measures
Full Information
NCT ID
NCT00235417
First Posted
October 6, 2005
Last Updated
June 7, 2007
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00235417
Brief Title
Stem Cell Therapy in Chronic Ischemic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Heart Failure, Congestive
Keywords
Bone Marrow Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Bone marrow transplantation
Primary Outcome Measure Information:
Title
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Thayssen, MDSci
Organizational Affiliation
Department of Cardiology, Odense University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Axel CP Diederichsen, phd
Organizational Affiliation
Department of Cardiology, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Odense University Hospital
City
Odense
State/Province
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
20233136
Citation
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.
Results Reference
derived
Learn more about this trial
Stem Cell Therapy in Chronic Ischemic Heart Failure
We'll reach out to this number within 24 hrs