Autologous Mesenchymal Stromal Cell Therapy in Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
JKastrup, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00644410
First received: March 20, 2008
Last updated: November 18, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Improvements in left ventricular function [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical improvements [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: September 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Mesenchymal stromal cells
Biological: Mesenchymal stromal cell
Mesenchymal stromal cells 20 - 40 mill.
Placebo Comparator: 2
Saline
Biological: Saline
12 injection with 0.2 ml saline

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 The Heart Centre, Rigshospitalet University Hospital Copenhagen, Denmark
  More Information

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received: March 20, 2008
Last Updated: November 18, 2013
Health Authority: Denmark: De Videnskabsetiske Komitéer for Region Hovedstaden.
Denmark: Danish Medicines Agency

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014