METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

NCT01666132 | Terminated Phase 1

• 1 other identifier: METHOD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Ischemic Heart Disease

Keywords

LVEF < 40%

Outcome Measures

Primary Outcomes (3)

• Troponin samples

  Measurements of Troponine after cell injection

  1 day after cell injection

• Number of patients with adverse events at short term

  within 1 week after cell injection

• Number of patients with adverse events at mid/long term

  up to 12 months after cell injection

Secondary Outcomes (3)

• change in LVEF

  6 months vs. baseline

• change in Quality of life

  6 months vs. baseline

• change in Vo2 max

  6 months vs. bl

Study Arms (3)

Intramyocardial injection of BM cells

EXPERIMENTAL

Other: intramyocardial injection of BM cells

Intramyocardial / intracoronary injection of BM cells

EXPERIMENTAL

Other: intramyocardial / intracoronary injection of BM cells

control

OTHER

Other: Best medical therapy

Interventions

intramyocardial injection of BM cells OTHER

only intramyocardial, NOGA guided injection on BM cells.

Intramyocardial injection of BM cells

intramyocardial / intracoronary injection of BM cells OTHER

combination of intramyocardial, NOGA guided injection of BM cells and intracoronary injection of those cells

Intramyocardial / intracoronary injection of BM cells

Best medical therapy OTHER

initially no intervention; crossover to therapy 6 months after enrollment

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cardiocentro Ticino: lead

Study Sites (1)

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Related Publications (2)

• Maffessanti F, Prinzen FW, Conte G, Regoli F, Caputo ML, Suerder D, Moccetti T, Faletra F, Krause R, Auricchio A. Integrated Assessment of Left Ventricular Electrical Activation and Myocardial Strain Mapping in Heart Failure Patients: A Holistic Diagnostic Approach for Endocardial Cardiac Resynchronization Therapy, Ablation of Ventricular Tachycardia, and Biological Therapy. JACC Clin Electrophysiol. 2018 Jan;4(1):138-146. doi: 10.1016/j.jacep.2017.08.011. Epub 2017 Nov 6.

  PMID: 29600778 DERIVED

• Surder D, Radrizzani M, Turchetto L, Cicero VL, Soncin S, Muzzarelli S, Auricchio A, Moccetti T. Combined delivery of bone marrow-derived mononuclear cells in chronic ischemic heart disease: rationale and study design. Clin Cardiol. 2013 Aug;36(8):435-41. doi: 10.1002/clc.22148. Epub 2013 May 29.

  PMID: 23720276 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; senior attendant of Cardiology

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: August 16, 2012
• Study Start: January 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

CH (1)