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METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

This study has been terminated.
(Due to the slow recruitment process and the progress of newer cell types we decided to stop the trial after the phase 1 (after 10 patients included))
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666132
First Posted: August 16, 2012
Last Update Posted: August 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Suerder, Cardiocentro Ticino
  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
Intervention Model: Crossover Assignment
Masking: None (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

Further study details as provided by Daniel Suerder, Cardiocentro Ticino:

Primary Outcome Measures:
  • Troponin samples [ Time Frame: 1 day after cell injection ]
    Measurements of Troponine after cell injection

  • Number of patients with adverse events at short term [ Time Frame: within 1 week after cell injection ]
  • Number of patients with adverse events at mid/long term [ Time Frame: up to 12 months after cell injection ]

Secondary Outcome Measures:
  • change in LVEF [ Time Frame: 6 months vs. baseline ]
    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 ]
  • change in Vo2 max [ Time Frame: 6 months vs. bl ]
    change in functional status (Vo2 max)


Enrollment: 10
Study Start Date: January 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666132


Locations
Switzerland
Cardiocentro Ticino
Lugano, Switzerland, 6900
Sponsors and Collaborators
Cardiocentro Ticino
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Suerder, MD; senior attendant of Cardiology, Cardiocentro Ticino
ClinicalTrials.gov Identifier: NCT01666132     History of Changes
Other Study ID Numbers: METHOD
First Submitted: June 27, 2011
First Posted: August 16, 2012
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by Daniel Suerder, Cardiocentro Ticino:
LVEF < 40%

Additional relevant MeSH terms:
Ischemia
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases