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

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ClinicalTrials.gov Identifier: NCT02462330
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Chronic Myocardial Ischemia Drug: Autologous MSC from bone marrow Drug: Placebo comparator Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 19, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Placebo Comparator: Placebo comparator
injection of human albumin 4%
Drug: Placebo comparator
injections of human albumin
Other Name: Human Albumin

Experimental: Autologous MSC from bone marrow
intramyocardial injection of 6.10e7 stem cells
Drug: Autologous MSC from bone marrow
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.
Other Name: mesenchymal stem cells




Primary Outcome Measures :
  1. Change in VO2max [ Time Frame: 3 months ]
    Change in VO2max (or peak VO2) before injection and at 3 months post injection.


Secondary Outcome Measures :
  1. Left ventricular viability [ Time Frame: Before injection and at 3, 6 and 12 months ]
    MRI

  2. NYHA/CCS class [ Time Frame: Before injection and at 3, 6 and 12 months ]
    Change on class

  3. Quality of life (Minnesota questionnaire) [ Time Frame: Before injection and at 3, 6 and 12 months ]
    Change on quality of life test score

  4. VO2 max [ Time Frame: At 6 and 12 months ]
    Change in VO2max (or peak VO2) at 6 and 12 months post injection.

  5. 6'walking-test [ Time Frame: Between 3 and 12 months ]
    Distance to walk test

  6. Echocardiography [ Time Frame: Before injection and at 3, 6 and 12 months ]
    Volume of myocardium and measurement of ejection fraction

  7. Myocardial perfusion imaging [ Time Frame: Before injection and at 3, 6 and 12 months ]
    Efficacy of the cell therapy on LVEF

  8. BNP blood test [ Time Frame: Before injection and at 3, 6 and 12 months ]
    Change of the BNP blood test at 3, 6 and 12 months


Other Outcome Measures:
  1. Adverse event related to cell administration [ Time Frame: 12 months ]
  2. Complication related to cell administration [ Time Frame: 12 months ]
  3. Control of the implantable cardioverter defibrillator [ Time Frame: 12 months ]
  4. Analysis of major cardiovascular events [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion criteria:

  • 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,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462330


Contacts
Contact: Jerôme Roncalli, MD, PhD 05 61 32 26 13 ext +33 roncalli.j@chu-toulouse.fr
Contact: Amandine Pauze 05 61 77 84 34 pauze.a@chu-toulouse.fr

Locations
France
University hospital of Henri Mondor Recruiting
Créteil, France, 94010
Contact: Emmanuel Teiger, MD, PhD    01 49 81 21 11 ext +33    emmanuel.teiger@hmn.aphp.fr   
Principal Investigator: Emmanuel Teiger, MD, PhD         
University hospital of Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Yannick Neuder    04 76 76 84 66 ext +33    YNeuder@chu-grenoble.fr   
Principal Investigator: Yannick Neuder, MD, PhD         
University hospital of Lille Not yet recruiting
Lille, France, 59037
Contact: Eric Van Belle, MD, PhD    03 20 44 59 62 ext +33    ericvanbelle@aol.com   
Principal Investigator: Eric Van Belle, MD, PhD         
University hospital of Nantes Not yet recruiting
Nantes, France, 44093
Contact: Jean-Noël Trochu, MD, PhD    02 40 16 52 77 ext +33    jeannoel.trochu@chu-nantes.fr   
Principal Investigator: Jean-Noël Trochu, MD, PhD         
University hospital of Pitié-Salpêtrière Recruiting
Paris, France, 75651
Contact: Richard Isnard, MD, PhD    01 42 16 30 09 ext +33    richard.isnard@psl.aphp.fr   
Principal Investigator: Richard Isnard, MD, PhD         
Cardiology Department of Rangueil Hospital - Rangueil Hospital Recruiting
Toulouse, France, 31059
Contact: Jerôme Roncalli, MD, PhD    05 61 32 26 13 ext +33    roncalli.j@chu-toulouse.fr   
Contact: Marine Lebrin    05 61 32 37 24 ext +33    lebrin.m@chu-toulouse.fr   
Principal Investigator: Jerôme Roncalli, MD, PhD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Jerôme Roncalli, MD, PhD Toulouse University Hospital

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02462330     History of Changes
Other Study ID Numbers: 10 142 01
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Toulouse:
Mesenchymal stem cells
ischemic cardiomyopathy
NogaStar XP system catheter

Additional relevant MeSH terms:
Ischemia
Cardiomyopathies
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases