A prospective, double blind, randomized, placebo-controlled clinical trial of intracoronary infusion of immunoselected, bone marrow-derived Stro3 mesenchymal precursor cells (MPC) in the treatment of patients with ST-elevation myocardial infarctio

Phase 2

Completed

Conditions: heart attack
ST-elevation myocardial infarction
10028593

Registration Number: NL-OMON45102

Lead Sponsor: Mesoblast Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 3

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 AMI (pain, etc.) for a maximum
of 12 hours from onset of symptoms to completion of 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 a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement
of an intrauterine device [IUD] or intrauterine system [IUS], condom or 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.

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 the LAD
7. History of persistent atrial fibrillation
8. Prior PCI involving 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 and non-melanoma skin cancer that has been definitively treated
10. Acute or chronic bacterial or viral infectious disease
11. Pacemaker, ICD or any other contra-indication 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 (e.g. gadolinium).
16. Known hypersensitivity to dimethyl zwaveloxide (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