METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Ischemic Heart Disease	Other: intramyocardial injection of BM cells Other: intramyocardial / intracoronary injection of BM cells Other: Best medical therapy	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	METHOD - Phase I/II Study of Intramyocardial Injection of Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Further study details as provided by Cardiocentro Ticino:

Primary Outcome Measures:

Troponin samples [ Time Frame: 1 day after cell injection ] [ Designated as safety issue: Yes ]
Measurements of Troponine after cell injection
Number of patients with adverse events at short term [ Time Frame: within 1 week after cell injection ] [ Designated as safety issue: Yes ]
Number of patients with adverse events at mid/long term [ Time Frame: up to 12 months after cell injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

change in LVEF [ Time Frame: 6 months vs. baseline ] [ Designated as safety issue: Yes ]
First 10 patients + following randomization phase (n = 54); assessment of short term safety (1 week), Adverse events within 1 year; efficacy measurements 6 months after treatment
change in Quality of life [ Time Frame: 6 months vs. baseline ] [ Designated as safety issue: No ]
change in Vo2 max [ Time Frame: 6 months vs. bl ] [ Designated as safety issue: No ]
change in functional status (Vo2 max)

Estimated Enrollment:	10
Study Start Date:	January 2011
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intramyocardial injection of BM cells	Other: intramyocardial injection of BM cells only intramyocardial, NOGA guided injection on BM cells.
Experimental: Intramyocardial / intracoronary injection of BM cells	Other: intramyocardial / intracoronary injection of BM cells combination of intramyocardial, NOGA guided injection of BM cells and intracoronary injection of those cells
control	Other: Best medical therapy initially no intervention; crossover to therapy 6 months after enrollment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666132

Contacts

Contact: Daniel Suerder, MD

+41918053360

daniel.suerder@cardiocentro.org

Locations

Switzerland
Cardiocentro Ticino	Recruiting
Lugano, Switzerland, 6900
Contact: Daniel Suerder, MD +41 918053360 daniel.suerder@cardiocentro.org
Principal Investigator: Tiziano Moccetti, MD

Sponsors and Collaborators

Cardiocentro Ticino

More Information

No publications provided

Responsible Party:	Daniel Suerder, MD; senior attendant of Cardiology, Cardiocentro Ticino
ClinicalTrials.gov Identifier:	NCT01666132 History of Changes
Other Study ID Numbers:	METHOD
Study First Received:	June 27, 2011
Last Updated:	August 15, 2012
Health Authority:	Switzerland: Swissmedic

Keywords provided by Cardiocentro Ticino:

LVEF < 40%

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013