A clinical trial of allogeneic mesenchymal precursor cells (MPCs) in the treatment of heart attacks.

Phase 1

Conditions: ST-elevation myocardial infarction
MedDRA version: 19.0Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2010-020497-41-NL

Lead Sponsor: Mesoblast, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 105

Inclusion Criteria

Subjects will be entered into this study only if they meet ALL of the following criteria:
1. Willing and able to understand and sign the Informed Consent Form (ICF).
2. Males or females = 18 years.
3. Clinical symptoms consistent with acute AMI (pain, etc.) for a maximum of 12 hours from onset of symptoms to percutaneous coronary intervention (PCI).
4. De novo anterior Acute Myocardial Infarct (AMI) defined as:
= 0.2 mV ST elevation in 2 or more V1 – V6 leads with presentation in a maximum of 12 hours of onset of symptoms
Or:
Presumed new left bundle branch block with a minimum of 0.1 mV concordant ST elevation with presentation in a maximum of 12 hours of onset of symptoms
And:
Occlusion or flow limiting lesion with TIMI Flow Grade 0 or 1 in the left anterior descending (LAD) coronary artery

5. Successful revascularization of the culprit lesion in the LAD within a maximum of 12 hours from the onset of AMI symptoms defined as (1) primary percutaneous coronary intervention (PCI) with stent implantation, resulting in TIMI 3 or 2 flow AND (2) residual stenosis of less than 20% by on-line QCA.

NOTE: Subject is eligible if in addition to requiring a primary PCI plus stenting for the culprit lesion they have a stenosis of the LAD that is both distinct from the culprit lesion and requires PCI at the time of the index cardiac catheterization procedure. For example, if the culprit lesion is in the mid LAD but there is also a high-grade first diagonal (D1) stenosis, then the latter lesion may undergo PCI (plus stenting) during the index catheterization This specifically excludes patients who may require a PCI to a non-LAD coronary artery during the index catheterization.

6. If a female subject is of childbearing potential (i.e. not amenorrheic for 12 or more months and/or not surgically sterile), the subject must be willing to use highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device [IUD] or intrauterine system [IUS], condom occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence)) for at least 16 weeks after investigational agent infusion.

7. Must be willing and able to return for required follow-up visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Subjects will not be enrolled into this study if they meet ANY of the following criteria:
1. Prior MI, known cardiomyopathy, or hospital admission for heart failure (HF).
2. Significant valvular disease (mitral or aortic valve regurgitation 3/4 classification as defined by ESC/ACC guidelines).
3. Unsuccessful revascularization of culprit artery defined as TIMI 1 or 0 flow or residual diameter stenosis of = 20% by on line QCA analysis.
4. Need for staged treatment of coronary artery disease, or other interventional or surgical procedures to treat heart disease (e.g., valve replacement, PCI or CABG) planned or scheduled within 6 months after infusion with the investigational agent. EXCEPT: Patients who present at the index catheterization with a need for a staged PCI of a non-LAD coronary artery will be eligible if:
-The staged PCI vessel does not have important collaterals to the LAD, and
-Agreement from the PI that the staged PCI can be safely scheduled after the day 30 cMRI has been determined by the Core cMR Imaging Laboratory to satisfy quality-control criteria
5. Cardiogenic shock or hemodynamic instability within 24 hours prior to randomization,defined as the presence of any of the following:
-Systolic blood pressure <80 mmHg lasting for more than 30 minutes
-Heart rate >120 bpm for more than 1 hour
6. Prior coronary artery bypass graft to LAD.
7. History of persistent atrial fibrillation.
8. Prior PCI involving the LAD.
9. Malignancy within last 3 years from screening. The subject has had an active malignancy, within the past 3 years except for cervical carcinoma in situ, or non-melanoma skin cancer that has been definitively treated.
10. Acute or chronic bacterial or viral infectious disease.
11. Pacemaker, ICD or any other contraindication for cMRI. This is inclusive of patients with an MRI compatible device that was implanted prior to the potential qualifying event.
12. Known history of severe chronic obstructive pulmonary Disease (Forced Expiratory Volume (FEV1) <35% in 1 second).
13. Known glomerular filtration rate (GFR) of less than 30 mL/min at study entry.
14. Known history of sensitization to human leukocyte antigens (such as via pregnancy, transfusions or organ transplant).
15. Known hypersensitivity to any radiographic contrast.
16. Known hypersensitivity to DMSO, murine proteins, bovine proteins, acetylsalicylic acid (ASA), clopidogrel, prasugrel, and/or metallic stents.
17. Prior or current participation in any bone marrow derived autologous and allogeneic stem cell or gene therapy study.
18. Prior participation in any other investigational drug trial in the past 30 days.
19. Pregnant or lactating women.
20. Intent to participate in any other investigational drug, cell or gene therapy study during the 2-year follow-up period of this study.
21. Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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