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Chronic Myocardial IschemiaPhase 2MESAMI2NCT02462330

Administration of Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy (MESAMI2)

A Phase 2 study testing Autologous MSC from bone marrow in people with Chronic Myocardial Ischemia, run by University Hospital, Toulouse at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stem cell therapy is an emerging treatment for cardiovascular disease but the best cell type and delivery method remain to be determined. Pre-clinical studies demonstrated improvement of cardiac function by Mesenchymal stem cells (MSC) therapy in particular by their paracrine and immunosuppressive properties. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Myocardial Ischemia
What is being tested?
Autologous MSC from bone marrow
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
6 sitesFrance
Study dates
19 Feb 2016to 19 Dec 2022
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient who signed the informed consent,
  • Chronic stable ischemic cardiomyopathy for at least one month with a NYHA Class II-IV and/or -Angina pectoris CCS Class III or IV,
  • Not a candidate for revascularization by coronary artery by-pass surgery or angioplasty,
  • Left ventricular function ≤45%,
  • Presence of ischemia or myocardial viability on the myocardial perfusion imaging,
  • VO2 max≤ 20 ml/min/kg,
  • Optimal medical therapy,
  • Optimal interventional therapy (Implantable Cardiovertor Defibrillator, effort rehabilitation).

Who cannot join

  • Pregnancy or breastfeeding,
  • Acute coronary syndrome or myocardial infarction during the last 3 months,
  • Revascularization (PCI or CABG), or cardiac resynchronization during the last 3 months,
  • Further revascularization planned for the next 30 days,
  • LVEF >45%,
  • Left intraventricular Thrombus and / or ventricular aneurysm detected by transthoracic echocardiography,
Show all 27Show fewer
  • Wall thickness in the target region <8 mm as determined by echocardiography,
  • Critical Limb Ischemia stages 3 or 4,
  • Inability to achieve a VO2 test,
  • Not feasible peripheral arterial access for percutaneous procedure,
  • Aortic stenosis (<1cm²) or aortic insufficiency (> 2 +),
  • Patients with transplanted organ,
  • Chronic renal failure with creatinemia ≥ 250 µmol/L,
  • Severe hepatic dysfunction,
  • Chronic atrial fibrillation,
  • Decompensated heart failure,
  • Uncontrolled Ventricular arrhythmias,
  • Indication of cardiac resynchronization by multisite pacemaker or cardiac resynchronization during the last 3 months,
  • Obesity preventing bone marrow aspiration or manual compression of the puncture area after bone marrow collection,
  • Active uncontrolled infection
  • Immuno-modulator treatment (ciclosporin, mycophenolate, mycophenolate mofetil, azathioprine, tacrolimus, anthracyclines, neupogen, hydrea, etanercept interferons, prednisolone, methylprednisolone, colchicine),
  • History of cancer in the last 5 years,
  • Hemopathy, hematopoietic disease,
  • Haemorrhagic syndrome,
  • Chronic or progressive disease that may alter the prognosis within 3 months,
  • Positive serologies for Human immunodeficiency virus (HIV1-2), HTLV-1 (human T-cell lymphotrophic virus) and 2, HBV (hepatitis B virus) or HCV (hepatitis B virus).
  • Allergic to xylocain.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • University hospital of Henri Mondor

    Créteil, 94010

  • University hospital of Grenoble

    Grenoble, 38043

  • University hospital of Lille

    Lille, 59037

  • University hospital of Nantes

    Nantes, 44093

  • University hospital of Pitié-Salpêtrière

    Paris, 75651

  • Cardiology Department of Rangueil Hospital - Rangueil Hospital

    Toulouse, 31059

Other trials in France

About this study

Official title: Effect of Intramyocardial Mesenchymal Stem Cells Injection in Patients With Chronic Ischemic Cardiomyopathy and Left Ventricular Dysfunction Guide by NogaStar XP System Catheter.

Stem cell therapy is an emerging treatment for cardiovascular disease but the best cell type and delivery method remain to be determined. Pre-clinical studies demonstrated improvement of cardiac function by Mesenchymal stem cells (MSC) therapy in particular by their paracrine and immunosuppressive properties. Investigators initiated the MESAMI program by the bicentric pilot phase and highlighted the safety and feasibility of intramyocardial injections of MSCs from bone marrow in patients with chronic ischemic cardiomyopathy and left ventricular dysfunction, guide by the NOGA-XP system. The MESAMI program continues with the phase 2, multicenter, double-blind, randomized, placebo-controlled trial.The aim of this phase 2 study is to demonstrate a functional improvement, measuring peak VO2, at 3 months between the cell therapy group and the placebo group.

Read the detailed description

Ischemic cardiomyopathies are a leading cause of death in both men and women. During the last decade, treatments for heart failure have evolved, but their purpose is to improve symptoms and prevent aggravation of the disease. Current research is focusing on the development of cell-based therapies using different sources of stem cells which can provide trophic and paracrine support or even replace dying cells with new ones. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. These cells are known for their ability to secrete paracrine factors and their immunosuppressive properties. The MESAMI 2 study will evaluate the efficacy of MSCs injection directly into the heart to repair and restore heart function in people with chronic ischemic heart failure using NOGA-XP system.

This phase 2 study is a prospective, multicenter, double-blind, randomized, placebo-controlled trial. A total of 90 patients will be randomized in 2 arms to receive intramyocardial injection of MSCs or placebo. Patients will be followed up for 13 months. Bone marrow will be collected and immediately transported to the French Blood Establishment for MSC isolation and expansion. Patients will receive intramyocardial injection of MSCs or placebo during a left heart catheterization.

Being tested
Autologous MSC from bone marrow, Placebo comparator
Keywords
Mesenchymal stem cells, ischemic cardiomyopathy, NogaStar XP system catheter

What participants receive

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

  • Autologous MSC from bone marrowDrug

    Also called mesenchymal stem cells

    After bone-marrow aspiration by an authorized person, MSCs were isolated and cultured during 17±2 days by the French Blood Establishment. Then, patients receive intramyocardial injections of MSCs using the electromechanical NOGA-XP system.

  • Placebo comparatorDrug

    Also called Human Albumin

    injections of human albumin

Study groups in NCT02462330
Study groupRoleWhat they receive
Placebo comparatorPlacebo comparatorinjection of human albumin 4%
Receives: Drug: Placebo comparator
Autologous MSC from bone marrowExperimentalintramyocardial injection of 6.10e7 stem cells
Receives: Drug: Autologous MSC from bone marrow

What is being measured

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

  1. Change in VO2max

    Change in VO2max (or peak VO2) before injection and at 3 months post injection.

    Measured: 3 months

Secondary outcomes (8)

  1. Left ventricular viability

    MRI

    Measured: Before injection and at 3, 6 and 12 months

  2. NYHA/CCS class

    Change on class

    Measured: Before injection and at 3, 6 and 12 months

  3. Quality of life (Minnesota questionnaire)

    Change on quality of life test score

    Measured: Before injection and at 3, 6 and 12 months

  4. VO2 max

    Change in VO2max (or peak VO2) at 6 and 12 months post injection.

    Measured: At 6 and 12 months

  5. 6'walking-test

    Distance to walk test

    Measured: Between 3 and 12 months

  6. Echocardiography

    Volume of myocardium and measurement of ejection fraction

    Measured: Before injection and at 3, 6 and 12 months

  7. Myocardial perfusion imaging

    Efficacy of the cell therapy on LVEF

    Measured: Before injection and at 3, 6 and 12 months

  8. BNP blood test

    Change of the BNP blood test at 3, 6 and 12 months

    Measured: Before injection and at 3, 6 and 12 months

Timeline

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

  1. First posted4 Jun 2015 (estimated)
  2. Study start19 Feb 2016
  3. Primary completion19 Dec 2022
  4. Study completion19 Dec 2022

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02462330
Sponsor's protocol ID
10 142 01
Acronym
MESAMI2
Status last verified
Mar 2023
First submitted
27 May 2015
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous MSC from bone marrow in people with Chronic Myocardial Ischemia, run by University Hospital, Toulouse at 6 sites in France.

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 8 inclusion and 27 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: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in VO2max (time frame: 3 months). 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 NCT02462330.

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 30 Mar 2023.

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