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Mesenchymal Stem Cells and Myocardial Ischemia (MESAMI)

Primary Purpose

Chronic Myocardial Ischemia, Left Ventricular Dysfunction

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Mesenchymal stem cells

About this trial

This is an interventional treatment trial for Chronic Myocardial Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 to 75
Male or female
NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with)
Chronic coronary artery disease with left ventricular function below 35%
Stable medical therapy for at least one month
Reversible perfusion defects by SPECT
Not a candidate for coronary artery by-pass surgery due to poor targets or small vessels and not a candidate for percutaneous intervention due to small vessels or unreachable coronary lesions due to complicated anatomy
Implantable Cardiovertor Defibrillator

Exclusion Criteria:

Acute coronary syndrome, revascularization (PCI or CABG), or cardiac resynchronization during the last 3 months
Sustained ventricular
Further revascularization planned for the next 30 days.
Chronic atrial fibrillation.
A wall thickness in the target region <8 mm as determined by 2D echocardiography (the target region is defined at the time of NOGA® mapping).
An LV thrombus.
Severe peripheral vascular disease precluding femoral artery access as determined at time of original catheterization.
Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to the LV.
Human immunodeficiency virus (HIV1-2), HTLV-1 and 2.
An active uncontrolled infection.
A prosthetic aortic valve.
A current or prior history within the last 3 years of neoplasm (excluding basal cell) and/or any active neoplasm within the last 24 months.
Pregnancy or breastfeeding.
Active participation in other research therapy for cardiovascular repair/regeneration.
Any medical condition that would affect the investigator's ability to evaluate the subject's condition or could compromise the subject's safety.
Any condition that, in the judgment of the investigator, would prohibit the subject from participating in the study.

Sites / Locations

University Hospital (Rangueil)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

Outcomes

Primary Outcome Measures

Evaluate safety and feasibility of transendocardial injection using the NogaStar XP Mapping Catheter with the MyostarTM Left Ventricular Injection Catheter of autologous MSC in subjects with chronic myocardial ischemia and left ventricular dysfunction

Secondary Outcome Measures

Change from baseline in SF-36, VO2max, 6 min walk test, and the NYHA, CCS Classifications Effect related to cardiac function

Full Information

NCT ID

NCT01076920

First Posted

February 10, 2010

Last Updated

September 18, 2014

Sponsor

University Hospital, Toulouse

Collaborators

French Blood Establishment, Nantes University Hospital, Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT01076920

Brief Title

Mesenchymal Stem Cells and Myocardial Ischemia

Acronym

MESAMI

Official Title

Administration of Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

Collaborators

French Blood Establishment, Nantes University Hospital, Ministry of Health, France

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Ischemic cardiomyopathies are a leading cause of death in both men and women. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the all damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety of injecting MSCs directly into the heart to repair and restore heart function in people who have had a heart attack and who have chronic myocardial ischemia with heart failure.

Detailed Description

Mesenchymal stem cells from the bone marrow can differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue. The aim of the study is in a phase I safety study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.10 patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 24 months follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Myocardial Ischemia, Left Ventricular Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention arm

Arm Type

Experimental

Intervention Type

Genetic

Intervention Name(s)

Mesenchymal stem cells

Intervention Description

60x106 MSCs Trans-endocardial intramyocardial injections (n=14-16)

Primary Outcome Measure Information:

Title

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Change from baseline in SF-36, VO2max, 6 min walk test, and the NYHA, CCS Classifications Effect related to cardiac function

Time Frame

30 days to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 to 75 Male or female NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with) Chronic coronary artery disease with left ventricular function below 35% Stable medical therapy for at least one month Reversible perfusion defects by SPECT Not a candidate for coronary artery by-pass surgery due to poor targets or small vessels and not a candidate for percutaneous intervention due to small vessels or unreachable coronary lesions due to complicated anatomy Implantable Cardiovertor Defibrillator Exclusion Criteria: Acute coronary syndrome, revascularization (PCI or CABG), or cardiac resynchronization during the last 3 months Sustained ventricular Further revascularization planned for the next 30 days. Chronic atrial fibrillation. A wall thickness in the target region <8 mm as determined by 2D echocardiography (the target region is defined at the time of NOGA® mapping). An LV thrombus. Severe peripheral vascular disease precluding femoral artery access as determined at time of original catheterization. Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to the LV. Human immunodeficiency virus (HIV1-2), HTLV-1 and 2. An active uncontrolled infection. A prosthetic aortic valve. A current or prior history within the last 3 years of neoplasm (excluding basal cell) and/or any active neoplasm within the last 24 months. Pregnancy or breastfeeding. Active participation in other research therapy for cardiovascular repair/regeneration. Any medical condition that would affect the investigator's ability to evaluate the subject's condition or could compromise the subject's safety. Any condition that, in the judgment of the investigator, would prohibit the subject from participating in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

jerome RONCALLI, MD, PhD

Organizational Affiliation

University Hospital Of TOULOUSE

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital (Rangueil)

City

Toulouse

ZIP/Postal Code

31059

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

26901787

Citation

Guijarro D, Lebrin M, Lairez O, Bourin P, Piriou N, Pozzo J, Lande G, Berry M, Le Tourneau T, Cussac D, Sensebe L, Gross F, Lamirault G, Huynh A, Manrique A, Ruidavet JB, Elbaz M, Trochu JN, Parini A, Kramer S, Galinier M, Lemarchand P, Roncalli J. Intramyocardial transplantation of mesenchymal stromal cells for chronic myocardial ischemia and impaired left ventricular function: Results of the MESAMI 1 pilot trial. Int J Cardiol. 2016 Apr 15;209:258-65. doi: 10.1016/j.ijcard.2016.02.016. Epub 2016 Feb 2.

Results Reference

derived

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Mesenchymal Stem Cells and Myocardial Ischemia

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