Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy
Recruitment status was Recruiting
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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 |
- Heart failure mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- 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 |
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| Contact: Bojan Vrtovec, MD, PhD | +38631 655 132 | bojan.vrtovec@gmail.com |
| Contact: Matjaz Sever, MD | +3861 522 2844 | matjaz.sever@gmail.com |
| Slovenia | |
| Ljubljana University Medical Center | Recruiting |
| Ljubljana, Slovenia, 1000 | |
| Principal Investigator: Bojan Vrtovec, MD, PhD | |
| 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 June 18, 2013