Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy (NOGA-DCM)
This study is currently recruiting participants.
Verified April 2013 by University Medical Centre Ljubljana
Sponsor:
University Medical Centre Ljubljana
Collaborators:
The Methodist Hospital System
Stanford University
Information provided by (Responsible Party):
Bojan Vrtovec, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01350310
First received: May 6, 2011
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
BACKGROUND. In patients with non-ischemic dilated cardiomyopathy, intracoronary stem cell transplantation has been shown to improve exercise capacity, reduce ventricular remodelling and improve 1-year survival. Pre-clinical data demonstrate that stem cell effects on the diseased heart can be further enhanced by direct intramyocardial delivery route.
AIMS.
- To evaluate safety and efficacy of intramyocardial stem cell therapy in patients with non-ischemic dilated cardiomyopathy.
- To directly compare clinical effects of intracoronary and intramyocardial stem cell delivery.
METHODS. Of 60 patients with dilated cardiomyopathy, 30 will be randomized to intramyocardial transplantation of CD34+ cells (Study Group), and 30 will receive intracoronary stem cell therapy (Control Group). In both groups peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labelled with technetium. In the Study Group electromechanical mapping will be used to identify viable myocardium and intramyocardial injections in the target areas will be performed with NOGA catheter. In the Control group patients will undergo myocardial perfusion scintigraphy and CD34+ cells will be injected intracoronary in the artery supplying segments of reduced viability. Patients will be followed for 1 year. Primary endpoints will include changes in left ventricular ejection fraction and left ventricular dimensions (measured by echocardiography). Secondary endpoints will include changes in exercise capacity and changes in NT-proBNP values.
HYPOTHESES.
- At 1 year, intramyocardial stem cell therapy will be associated with improved left ventricular ejection fraction, reduced left ventricular dimensions, improved exercise capacity and reduced levels of NT-proBNP.
- Beneficial effects of intramyocardial stem cell therapy will be superior to those observed with intracoronary stem cell delivery.
| Condition | Intervention | Phase |
|---|---|---|
|
Dilated Cardiomyopathy Chronic Heart Failure |
Procedure: Intramyocardial injection Procedure: Intracoronary injection |
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: | Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy |
Resource links provided by NLM:
Further study details as provided by University Medical Centre Ljubljana:
Primary Outcome Measures:
- Changes in left ventricular ejection fraction and dimensions [ Time Frame: 1 year ] [ Designated as safety issue: No ]Standard 2D and Doppler echocardiography will be performed at baseline, and repeated at 1 month, 3 months, 6 months and 1 year after the procedure. Left ventricular ejection fraction will be measured using Simpson's method and left ventricular end-systolic and end-diastolic dimensions will be measured according to standard echocardiography protocol.
Secondary Outcome Measures:
- Changes in exercise capacity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Exercise capacity will be evaluated with 6-minute walk test at baseline, and again at 1,3,6 and 12 months after the procedure.
- Change in NT-proBNP levels [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Plasma levels of NT-proBNP will be measured at baseline, and again at 1, 3, 6 and 12 months after the procedure.
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intramyocardial Injections
Peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labelled with technetium. Electromechanical mapping will be used to identify viable myocardium and intramyocardial injections in the target areas will be performed with NOGA catheter. Nuclear imaging for quantitation of myocardial retention rates of labeled cells will be performed at 2 and 18 hours after the procedure.
|
Procedure: Intramyocardial injection
Electromechanical mapping will be used to identify viable myocardium (unipolar voltage >6.9 mV) and intramyocardial injections in the target areas will be performed with NOGA catheter (25 injections of 0.3 cc).
|
|
Active Comparator: Intracoronary Injections
Peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labelled with technetium. Patients will undergo myocardial perfusion scintigraphy and CD34+ cells will be injected intracoronary in the artery supplying segments of reduced viability. Nuclear imaging for quantitation of myocardial retention rates of labeled cells will be performed at 2 and 18 hours after the procedure.
|
Procedure: Intracoronary injection
Patients will undergo myocardial perfusion scintigraphy for myocardial viability assessment. Microcatheter will be placed in the mid segment of the coronary artery supplying the segments of reduced tracer accumulation and repeated intracoronary injections of stem cell solution will be performed.
|
|
Active Comparator: Ischemic heart disease
Peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labelled with technetium. Electromechanical mapping will be used to identify viable myocardium and intramyocardial injections in the target areas will be performed with NOGA catheter. Nuclear imaging for quantitation of myocardial retention rates of labeled cells will be performed at 2 and 18 hours after the procedure
|
Procedure: Intramyocardial injection
Procedure/Surgery: Intramyocardial injection Electromechanical mapping will be used to identify viable myocardium (unipolar voltage >6.9 mV) and intramyocardial injections in the target areas will be performed with NOGA catheter (25 injections of 0.3 cc).
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Established dg. of dilated CMP (defined according to ESC position statement - absence of any stenotic lesions on coronary angiography, no congenital heart disease, no primary valve disease on echocardiography, and no history of hypertension or alcohol abuse1)
- left ventricular ejection fraction < 30%
- NYHA functional class III or IV for at least 3 months before referral
- Optimal medical management for at least 6 months
Exclusion Criteria:
- Left ventricular aneurysm or thrombus
- Hematologic disease
- Multiorgan failure
- Active malignancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350310
Contacts
| Contact: Bojan Vrtovec, MD, PhD | +3861 522 1148 | bojan.vrtovec@gmail.com |
| Contact: Gregor Poglajen, MD | gregor.poglajen@gmail.com |
Locations
| Slovenia | |
| UMC Ljubljana | Recruiting |
| Ljubljana, Slovenia, 1000 | |
| Principal Investigator: Bojan Vrtovec, MD, PhD | |
| Sub-Investigator: Matjaž Sever, MD | |
| Sub-Investigator: Luka Ležaič, MD | |
| Sub-Investigator: Dragoslav Domanovic, MD, PhD | |
| Sub-Investigator: Gregor Poglajen, MD | |
| Sub-Investigator: Miran Šebeštjen, MD, PhD | |
| Sub-Investigator: Renata Okrajšek, MD, PhD | |
Sponsors and Collaborators
University Medical Centre Ljubljana
The Methodist Hospital System
Stanford University
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: | Bojan Vrtovec, Prof. Dr. Bojan Vrtovec, dr. med., University Medical Centre Ljubljana |
| ClinicalTrials.gov Identifier: | NCT01350310 History of Changes |
| Other Study ID Numbers: | NOGA-DCM |
| Study First Received: | May 6, 2011 |
| Last Updated: | April 9, 2013 |
| Health Authority: | Slovenia: Ethics Committee |
Keywords provided by University Medical Centre Ljubljana:
|
Heart failure Dilated cardiomyopathy Stem cells |
Additional relevant MeSH terms:
|
Cardiomyopathy, Dilated Heart Failure Cardiomyopathies |
Cardiomegaly Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013