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

February 25, 2008
May 5, 2011
May 2006
May 2012   (final data collection date for primary outcome measure)
Heart failure mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00629018 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in Exercise Capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Changes in Electropysiologic 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 ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy
The Effects of Autologous Intracoronary Stem Cell Transplantation In Patients With End-Stage Dilated Cardiomyopathy

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Dilated Cardiomyopathy
  • 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
  • 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).
  • Active Comparator: 1
    Intervention: Biological: CD34+ autologous stem cell transplantation
  • Placebo Comparator: 2
    Intervention: Drug: Bone Marrow Stimulation
Vrtovec B, Poglajen G, Sever M, Lezaic L, Domanovic D, Cernelc P, Haddad F, Torre-Amione G. Effects of intracoronary stem cell transplantation in patients with dilated cardiomyopathy. J Card Fail. 2011 Apr;17(4):272-81. doi: 10.1016/j.cardfail.2010.11.007. Epub 2010 Dec 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Bojan Vrtovec, MD, PhD +38631 655 132 bojan.vrtovec@gmail.com
Contact: Matjaz Sever, MD +3861 522 2844 matjaz.sever@gmail.com
Slovenia
 
NCT00629018
DCM-SCT1
Yes
Peter Cernelc, Ljubljana University Medical Center
University Medical Centre Ljubljana
Blood Transfusion Centre of Slovenia
Study Director: Guillermo Torre Amione, MD, PhD Methodist DeBakey Heart Center, Houston TX, USA
University Medical Centre Ljubljana
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP