METHOD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-04-30

Brief Summary

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Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients with chronic ischemic heart disease and LVEF \< 40%. The primary objective is to determine whether the administration of the cells improves recovery of the left ventricular function. Secondary objective is the finding of clinical or paraclinical parameters to predict potential benefits of the treatment (basing on MRI characteristics such as size, transmurality of the myocardial infarction and peri-lesional ischemia).

In the first part of the study 10 patients are treated without control group. This phase serves as feasibility and safety part of the study.

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Detailed Description

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Conditions

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Chronic Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intramyocardial injection of BM cells

Group Type EXPERIMENTAL

intramyocardial injection of BM cells

Intervention Type OTHER

only intramyocardial, NOGA guided injection on BM cells.

Intramyocardial / intracoronary injection of BM cells

Group Type EXPERIMENTAL

intramyocardial / intracoronary injection of BM cells

Intervention Type OTHER

combination of intramyocardial, NOGA guided injection of BM cells and intracoronary injection of those cells

control

Group Type OTHER

Best medical therapy

Intervention Type OTHER

initially no intervention; crossover to therapy 6 months after enrollment

Interventions

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intramyocardial injection of BM cells

only intramyocardial, NOGA guided injection on BM cells.

Intervention Type OTHER

intramyocardial / intracoronary injection of BM cells

combination of intramyocardial, NOGA guided injection of BM cells and intracoronary injection of those cells

Intervention Type OTHER

Best medical therapy

initially no intervention; crossover to therapy 6 months after enrollment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic cardiac ischemic disease at least 4 months after one ore more myocardial infarctions in a stable phase of the disease without option for revascularization
* LVEF at echocardiography ≤ 40%
* Significant regional LV wall motion dysfunction in the infarct related territory
* Symptoms NYHA II-IV or CCS II-III (at least class III according to one of the two classifications)
* Patient agrees to comply with all follow-up evaluations
* Age \> 18 years old
* Patient has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent

Exclusion Criteria

* Abnormal regional wall motion outside the infarct region
* Need for revascularization in a non infarct-related coronary within 6 months
* Patient has moderate to severe aortic valve disease, aortic or mitral prosthetic valve
* Patient has a significant mitral valve insufficiency (Effective Regurgitant office - ERO - \> 0.2 cm2 with possibility of mitral valve surgery
* Left ventricular thrombus at echocardiography
* LV-aneurysma planned surgical aneurysmectomy
* LV-wall thickness \< 5mm in the target territory
* Congenital heart disorder of hemodynamic relevance
* Known active infection or chronic infection with HIV, HBV or HCV
* Chronic inflammatory disease
* Serious concomitant disease with a life expectancy of less than one year
* Follow up impossible (no fixed abode, etc)
* Contraindication for cardiac MRI (i.e. pace maker, neurostimulator, claustrophobia)
* Severe renal failure (creatinine \> 250 mmol/l)
* Relevant liver disease (GOT \> 2x norm or spontaneous INR \> 1,5)
* Anemia (Hb \< 8.5 mg/dl), Thrombocytopenia (\< 100.000/µl)
* Women of child bearing potential or pregnancy
* Participation at a clinical trial in the last 30 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No