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Chronic Ischemic Heart DiseasePhase 1/2NCT01666132

METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

A Phase 1/2 study testing intramyocardial injection of BM cells, intramyocardial / intracoronary injection of BM cells and Best medical therapy in people with Chronic Ischemic Heart Disease, run by Cardiocentro Ticino at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Ischemic Heart Disease
What is being tested?
intramyocardial injection of BM cells, intramyocardial / intracoronary injection of BM cells and Best medical therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSwitzerland
Study dates
Jan 2011to Apr 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Cardiocentro Ticino

    Lugano, 6900

Other trials in Switzerland

About this study

Official title: 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.

Being tested
intramyocardial injection of BM cells, intramyocardial / intracoronary injection of BM cells, Best medical therapy
Keywords
LVEF < 40%

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intramyocardial injection of BM cellsOther

    only intramyocardial, NOGA guided injection on BM cells.

  • intramyocardial / intracoronary injection of BM cellsOther

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

  • Best medical therapyOther

    initially no intervention; crossover to therapy 6 months after enrollment

Study groups in NCT01666132
Study groupRoleWhat they receive
Intramyocardial injection of BM cellsExperimentalNot described
Receives: Other: intramyocardial injection of BM cells
Intramyocardial / intracoronary injection of BM cellsExperimentalNot described
Receives: Other: intramyocardial / intracoronary injection of BM cells
controlOtherNot described
Receives: Other: Best medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Troponin samples

    Measurements of Troponine after cell injection

    Measured: 1 day after cell injection

  2. Number of patients with adverse events at short term

    Measured: within 1 week after cell injection

  3. Number of patients with adverse events at mid/long term

    Measured: up to 12 months after cell injection

Secondary outcomes (3)

  1. 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

    Measured: 6 months vs. baseline

  2. change in Quality of life

    Measured: 6 months vs. baseline

  3. change in Vo2 max

    change in functional status (Vo2 max)

    Measured: 6 months vs. bl

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2012 (estimated)
  2. Study startJan 2011
  3. Primary completionApr 2015
  4. Study completionApr 2015

Why it stopped: Due to the slow recruitment process and the progress of newer cell types we decided to stop the trial after the phase 1 (after 10 patients included)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01666132
Sponsor's protocol ID
METHOD
Status last verified
Aug 2015
First submitted
27 Jun 2011
Last updated
20 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29600778

  • 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.

    PubMed 23720276

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing intramyocardial injection of BM cells, intramyocardial / intracoronary injection of BM cells and Best medical therapy in people with Chronic Ischemic Heart Disease, run by Cardiocentro Ticino at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to the slow recruitment process and the progress of newer cell types we decided to stop the trial after the phase 1 (after 10 patients included)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Troponin samples (time frame: 1 day after cell injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01666132, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015; AzTrials last refreshed its copy on 29 Oct 2026.

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