METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

August 19, 2015 updated by: Daniel Suerder, Cardiocentro Ticino

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lugano, Switzerland, 6900
        • Cardiocentro Ticino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control
Other: Best medical therapy
initially no intervention; crossover to therapy 6 months after enrollment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Troponin samples
Time Frame: 1 day after cell injection
Measurements of Troponine after cell injection
1 day after cell injection
Number of patients with adverse events at short term
Time Frame: within 1 week after cell injection
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
up to 12 months after cell injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months vs. baseline
change in Quality of life
Time Frame: 6 months vs. baseline
6 months vs. baseline
change in Vo2 max
Time Frame: 6 months vs. bl
change in functional status (Vo2 max)
6 months vs. bl

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiocentro Ticino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METHOD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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