METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

Chronic Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01666132
• Other study ID #: METHOD
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: June 27, 2011
• Last updated: August 19, 2015
• Start date: January 2011
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Cardiocentro Ticino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Ischemic Heart Disease
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Cardiocentro Ticino	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Cardiocentro Ticino

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin samples	Measurements of Troponine after cell injection	1 day after cell injection	Yes
Primary	Number of patients with adverse events at short term		within 1 week after cell injection	Yes
Primary	Number of patients with adverse events at mid/long term		up to 12 months after cell injection	Yes
Secondary	change in LVEF	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	6 months vs. baseline	Yes
Secondary	change in Quality of life		6 months vs. baseline	No
Secondary	change in Vo2 max	change in functional status (Vo2 max)	6 months vs. bl	No