METHOD - Phase I/II Study of Intramyocardial Injection of Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Troponin samples
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intramyocardial injection of BM cells
Intervention: intramyocardial injection of BM cells (Other)
Intramyocardial / intracoronary injection of BM cells
Intervention: intramyocardial / intracoronary injection of BM cells (Other)
control
Intervention: Best medical therapy (Other)
Outcomes
Primary Outcomes
Troponin samples
Time Frame: 1 day after cell injection
Measurements of Troponine after cell injection
Number of patients with adverse events at mid/long term
Time Frame: up to 12 months after cell injection
Number of patients with adverse events at short term
Time Frame: within 1 week after cell injection
Secondary Outcomes
- change in LVEF(6 months vs. baseline)
- change in Quality of life(6 months vs. baseline)
- change in Vo2 max(6 months vs. bl)
Investigators
Daniel Suerder
MD; senior attendant of Cardiology
Cardiocentro Ticino