Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Medical Centre Ljubljana.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Blood Transfusion Centre of Slovenia
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00629018
First received: February 25, 2008
Last updated: May 5, 2011
Last verified: January 2010
  Purpose

Several studies have documented that transplantation of bone marrow-derived cells (BMC) following acute myocardial infarction is associated with a reduction in infarct scar size and improvements in left ventricular function and perfusion. The available evidence in humans suggests that BMC transplantation is associated with improvements in physiologic and anatomic parameters in both acute myocardial infarction and chronic ischemic heart disease, above and beyond the conventional therapy. In particular, intracoronary application of BMC is proved to be safe and was associated with significant improvement in the left ventricular ejection fraction (LVEF) in patients with chronic heart failure.

In contrast to ischemic heart failure, the data on effects of BMC transplantation in patients with dilated cardiomyopathy are limited to pre-clinical studies. In a rat model of dilated cardiomyopathy, intramyocardial delivery of pluripotent mesenchymal cells improved LVEF, possibly through induction of myogenesis and angiogenesis, as well as by inhibition of myocardial fibrosis, suggesting that the beneficial effects of stem cell transplantation in dilated cardiomyopathy may primarily be related to their ability to supply large amounts of angiogenic, antiapoptotic, and mitogenic factors. Similarly, transplantation of cocultured mesenchymal stem cells and skeletal myoblasts was shown to improve LVEF in a murine model of Chagas disease.

Study Aim:

To define the clinical effects of BMC transplantation in dilated cardiomyopathy in a pilot clinical study investigating the effects of intracoronary CD34+ cell transplantation on functional, structural, neurohormonal, and electrophysiologic parameters in patients with end-stage dilated cardiomyopathy.


Condition Intervention Phase
Dilated Cardiomyopathy
Biological: CD34+ autologous stem cell transplantation
Drug: Bone Marrow Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Autologous Intracoronary Stem Cell Transplantation In Patients With End-Stage Dilated Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Heart failure mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in exercise capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Changes in electrophysiologic properties of ventricular myocardium [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Changes in plasma inflammatory markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in left ventricular function [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2006
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Biological: CD34+ autologous stem cell transplantation
Peripheral blood stem cells will be mobilized by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labeled with technetium. Patients will undergo myocardial perfusion scintigraphy for myocardial viability assessment and the collected CD34+ cells will be injected intracoronary in the artery supplying the segments of reduced tracer accumulation
Placebo Comparator: 2 Drug: Bone Marrow Stimulation
Patients will undergo filgrastim stimulation and viability assessment using the same protocol as in Arm 1. However, in this group, no intracoronary stem cell delivery will be performed; the patients will receive placebo (saline).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normal coronary angiogram
  • Left ventricular ejection fraction < 40%
  • NYHA III or IV heart failure symptoms
  • Bone marrow reactivity (G-CSF test)
  • Presence of viable myocardium

Exclusion Criteria:

  • Hematologic malignancy
  • Multiorgan failure
  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: NCT00629018

Contacts
Contact: Bojan Vrtovec, MD, PhD +38631 655 132 bojan.vrtovec@gmail.com
Contact: Matjaz Sever, MD +3861 522 2844 matjaz.sever@gmail.com

Locations
Slovenia
Ljubljana University Medical Center Recruiting
Ljubljana, Slovenia, 1000
Principal Investigator: Bojan Vrtovec, MD, PhD         
Sponsors and Collaborators
University Medical Centre Ljubljana
Blood Transfusion Centre of Slovenia
Investigators
Study Director: Guillermo Torre Amione, MD, PhD Methodist DeBakey Heart Center, Houston TX, USA
  More Information

No publications provided by University Medical Centre Ljubljana

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Cernelc, Ljubljana University Medical Center
ClinicalTrials.gov Identifier: NCT00629018     History of Changes
Other Study ID Numbers: DCM-SCT1
Study First Received: February 25, 2008
Last Updated: May 5, 2011
Health Authority: Slovenia: Ministry of Health

Keywords provided by University Medical Centre Ljubljana:
Stem Cells
Heart Failure
Dilated Cardiomyopathy

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014