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

NCT02462330 | Completed Phase 2 DMC

• 1 other identifier: 10 142 01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 6

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.

Conditions

Chronic Myocardial Ischemia

Keywords

Mesenchymal stem cells; ischemic cardiomyopathy; NogaStar XP system catheter

Outcome Measures

Primary Outcomes (1)

• Change in VO2max

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

  3 months

Secondary Outcomes (8)

• Left ventricular viability

  Before injection and at 3, 6 and 12 months

• NYHA/CCS class

  Before injection and at 3, 6 and 12 months

• Quality of life (Minnesota questionnaire)

  Before injection and at 3, 6 and 12 months

• VO2 max

  At 6 and 12 months

• 6'walking-test

  Between 3 and 12 months

Other Outcomes (4)

• Adverse event related to cell administration

  12 months

• Complication related to cell administration

  12 months

• Control of the implantable cardioverter defibrillator

  12 months

Study Arms (2)

Placebo comparator

PLACEBO COMPARATOR

injection of human albumin 4%

Drug: Placebo comparator

Autologous MSC from bone marrow

EXPERIMENTAL

intramyocardial injection of 6.10e7 stem cells

Drug: Autologous MSC from bone marrow

Interventions

Autologous MSC from bone marrow DRUG

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.

Also known as: mesenchymal stem cells

Autologous MSC from bone marrow

Placebo comparator DRUG

injections of human albumin

Also known as: Human Albumin

Placebo comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (6)

University hospital of Henri Mondor

Créteil, 94010, France

Location

University hospital of Grenoble

Grenoble, 38043, France

Location

University hospital of Lille

Lille, 59037, France

Location

University hospital of Nantes

Nantes, 44093, France

Location

University hospital of Pitié-Salpêtrière

Paris, 75651, France

Location

Cardiology Department of Rangueil Hospital - Rangueil Hospital

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Serum Albumin, Human

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Jerôme Roncalli, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 4, 2015
• Study Start: February 19, 2016
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)