We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Mesenchymal Stromal Cell Therapy in Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644410
First Posted: March 26, 2008
Last Update Posted: March 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JKastrup, Rigshospitalet, Denmark
  Purpose

It is a single centre, randomised controlled study of the effect of NOGA-guided direct intramyocardial injection of mesenchymal stromal cells on the development of new myocardium and blood vessels in patients with heart failure.

Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before injected into the myocardium.

The patients will be followed with safety, clinical, MRI and CT endpoints for 1 year.


Condition Intervention Phase
Congestive Heart Failure Biological: Mesenchymal stromal cell Biological: Saline Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Centre, Randomised Controlled Study of the Effect of NOGA-guided Direct Intramyocardial Injection of Mesenchymal Stromal Cells on the Development of New Myocardium and Blood Vessels in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by JKastrup, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Improvements in left ventricular function [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures:
  • Clinical improvements [ Time Frame: 6 and 12 months ]

Enrollment: 59
Study Start Date: September 2008
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
The number of mesenchymal stromal cells reached after two culture expansion passages.
Biological: Mesenchymal stromal cell
Mesenchymal stromal cells 20 - 40 mill.
Placebo Comparator: 2
Saline
Biological: Saline
12 injection with 0.2 ml saline

Detailed Description:

The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of mesenchymal stromal cells in patients with reduced left ventricular EF (≤45%) and heart failure NYHA 2-3.

A total of 60 patients with will be enrolled in the study and randomised 2: 1 to cells or placebo (saline).

The patients will be followed for 12 months. The primary endpoint is changes in left ventricle end-systolic volume (LVESV) at 6 months follow-up.

The secondary endpoints are changes in left ventricular ejection fraction (LVEF), end-diastolic volume and end-systolic mass at 6 months follow-up.

Other secondary endpoints are NYHA, CCS, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6 min walking test, and major adverse events endpoints: all-causes death, cardiovascular death, and hospitalization for worsening heart failure and MI at 12 months follow-up.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • EF < 45 %
  • NYHA 2 - 3

Exclusion Criteria:

  • Acute coronary syndrome within last 6 weeks.
  • Pregnancy
  • FEV1 <1.0
  • Cancer
  • Any severe disease which could interfere with the treatment or the outcome
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644410


Locations
Denmark
The Heart Centre, Rigshospitalet University Hospital Copenhagen,
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Jens Kastrup, MD DMSc Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JKastrup, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00644410     History of Changes
Other Study ID Numbers: MSC heart failure
First Submitted: March 20, 2008
First Posted: March 26, 2008
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by JKastrup, Rigshospitalet, Denmark:
heart failure
stem cell
mesenchymal stromal cell
mesenchymal stem cell

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases