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Autologous Mesenchymal Stromal Cell Therapy in Heart Failure

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. Identifier: NCT00644410
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
JKastrup, Rigshospitalet, Denmark

Brief Summary:

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 or disease Intervention/treatment Phase
Congestive Heart Failure Biological: Mesenchymal stromal cell Biological: Saline Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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
Biological: Saline
12 injection with 0.2 ml saline

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

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

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.

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

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

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 identifier (NCT number): NCT00644410

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The Heart Centre, Rigshospitalet University Hospital Copenhagen,
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Jens Kastrup, MD DMSc Rigshospitalet, Denmark
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: JKastrup, Professor, Rigshospitalet, Denmark Identifier: NCT00644410    
Other Study ID Numbers: MSC heart failure
First Posted: March 26, 2008    Key Record Dates
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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases