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METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

NCT01666132 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-08-20

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Ischemic Heart Disease

Interventions

OTHER

intramyocardial injection of BM cells

only intramyocardial, NOGA guided injection on BM cells.

OTHER

intramyocardial / intracoronary injection of BM cells

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

OTHER

Best medical therapy

initially no intervention; crossover to therapy 6 months after enrollment

Sponsors & Collaborators

  • Cardiocentro Ticino

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01666132 on ClinicalTrials.gov