- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629018
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ljubljana, Slovenia, 1000
- Ljubljana University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SC Group
SC 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 |
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).
Other Names:
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
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NO_INTERVENTION: Controls
Patients receiving no cell therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Failure Mortality
Time Frame: 5 years
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5 years
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Changes in Left Ventricular Ejection Fraction
Time Frame: 5 years
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Left ventricular ejection fraction measured by echocardiography
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5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in Exercise Capacity
Time Frame: 5 years
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5 years
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Changes in Electrophysiologic Properties of Ventricular Myocardium
Time Frame: 6 months
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6 months
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Changes in Plasma Inflammatory Markers
Time Frame: 6 months
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6 months
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Changes in Left Ventricular Function
Time Frame: 5 years
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5 years
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Collaborators and Investigators
Investigators
- Study Director: Guillermo Torre Amione, MD, PhD, Methodist DeBakey Heart Center, Houston TX, USA
- Study Director: Francois Haddad, MD, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCM-SCT1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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