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

Phase 1

• Conditions: ST-elevation myocardial infarction; MedDRA version: 20.0Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-020497-41-SE
• Lead Sponsor: Mesoblast, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-14
• Last Update Posted: 21 June 2021

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 for 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 for a minimum of 2 hours and 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.

6. If a femail 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. If a female subject of childbearing potential (i.e., not amenorrheic for 12 months and/or not surgically sterile), then the subject must have a negative urine pregnancy test at screening, prior to investigational agent infusion.

8. 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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

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.
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 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 contra-indication for cMRI.
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 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