METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Cardiocentro Ticino.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Daniel Suerder, Cardiocentro Ticino
ClinicalTrials.gov Identifier:
NCT01666132
First received: June 27, 2011
Last updated: August 15, 2012
Last verified: August 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Cardiocentro Ticino

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

ClinicalTrials.gov processed this record on October 19, 2014