Trial | NCT01666132  Report issue

Title

METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease
METHOD - Phase I/II Study of Intramyocardial Injection of Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    10
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.
Study Started
Jan 31
2011
Primary Completion
Apr 30
2015
Study Completion
Apr 30
2015
Last Update
Aug 20
2015
Estimate

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

Intramyocardial injection of BM cells Experimental

Intramyocardial / intracoronary injection of BM cells Experimental

control Other

Criteria 

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
No Results Posted