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
1 other identifier
interventional
110
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
May 12, 2015
CompletedMay 12, 2015
April 1, 2015
6.9 years
February 25, 2008
April 9, 2013
April 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Heart Failure Mortality
5 years
Changes in Left Ventricular Ejection Fraction
Left ventricular ejection fraction measured by echocardiography
5 years
Secondary Outcomes (4)
Changes in Exercise Capacity
5 years
Changes in Electrophysiologic Properties of Ventricular Myocardium
6 months
Changes in Plasma Inflammatory Markers
6 months
Changes in Left Ventricular Function
5 years
Study Arms (2)
SC Group
EXPERIMENTALSC therapy,'Bone Marrow Stimulation','CD34+ autologous stem cell transplantation': In the SC group, CD34+ cells were mobilized by granulocyte colony-stimulating factor and collected via apheresis. Patients underwent myocardial scintigraphy and cells were injected in the artery supplying segments with the greatest perfusion defect
Controls
NO INTERVENTIONPatients receiving no cell therapy.
Interventions
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
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).
In the SC group, CD34+ cells were mobilized by granulocyte colony-stimulating factor and collected via apheresis. Patients underwent myocardial scintigraphy and cells were injected in the artery supplying segments with the greatest perfusion defect
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hematologic malignancy
- Multiorgan failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Centre Ljubljanalead
- Blood Transfusion Centre of Sloveniacollaborator
- Stanford Universitycollaborator
Study Sites (1)
Ljubljana University Medical Center
Ljubljana, 1000, Slovenia
Related Publications (1)
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.
PMID: 21440864DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Dr. Bojan Vrtovec
- Organization
- UMC Ljubljana
Study Officials
- STUDY DIRECTOR
Guillermo Torre Amione, MD, PhD
Methodist DeBakey Heart Center, Houston TX, USA
- STUDY DIRECTOR
Francois Haddad, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. dr. Bojan vrtovec
Study Record Dates
First Submitted
February 25, 2008
First Posted
March 5, 2008
Study Start
May 1, 2006
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
May 12, 2015
Results First Posted
May 12, 2015
Record last verified: 2015-04