NCT00235417

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 8, 2007

Status Verified

June 1, 2007

First QC Date

October 6, 2005

Last Update Submit

June 7, 2007

Conditions

Myocardial IschemiaHeart Failure, Congestive

Keywords

Bone Marrow Transplantation

Outcome Measures

Primary Outcomes (1)

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

Interventions

Bone marrow transplantationPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Odense University Hospital

Odense, Odense C, DK-5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 20233136DERIVED

MeSH Terms

Conditions

Myocardial IschemiaHeart Failure

Interventions

Bone Marrow Transplantation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Per Thayssen, MDSci

    Department of Cardiology, Odense University Hospital

    STUDY DIRECTOR

  • Axel CP Diederichsen, phd

    Department of Cardiology, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

October 1, 2005

Study Completion

May 1, 2007

Last Updated

June 8, 2007

Record last verified: 2007-06

Locations

DK(1)