Myocardial Infarction
Conditions
Keywords
Acute myocardial infarction, AMI, Myocardial infarction, Heart attack, Mesenchymal stem cells, MSC, Adult human stem cells, Osiris
Brief summary
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
Detailed description
The standard of care treatment for acute myocardial infarction (AMI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants, Beta-Blockers, nitrates and Ace-inhibitors. However, because salvaging the viable myocardium is dependent on early reperfusion, only a minority of participants will reach the hospital within the time-window for myocardial rescue. Thus, even if the participant manages their tobacco use, hypertension, lipid levels, diabetes, weight and exercise, many participants will go on to develop Congestive Heart Failure (CHF). Though the medical management for CHF may improve symptoms and slow disease progression, such treatment cannot restore a functioning myocardium. A therapy that could improve the myocardial remodeling process and reduce the incidence or severity of CHF following acute MI would provide a significant benefit. The characteristics and biologic activity of Prochymal®, along with a good safety profile in human trials to date, suggest that Prochymal® may be a good candidate for addressing this unmet medical need.
Interventions
DRUGProchymal®
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
DRUGPlacebo
Intravenous infusion of excipients of Prochymal®
Sponsors
Mesoblast, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between 21 and 85 years old, inclusive * First heart attack within 7 days prior to randomization and drug infusion * Baseline left ventricular ejection fraction (LVEF) 20-45% * Hemodynamically stable within 24 hours prior to randomization * Adequate pulmonary function
Exclusion criteria
* Previous medical history of heart attack, heart failure, significant valvular heart disease, aortic dissection * Pacemaker or other device * Pregnant, breast-feeding, or intends to become pregnant during the study * Allergy to cow or pig derived products * Evidence of active malignancy or prior history of active malignancy * Major surgical procedure or major trauma within the past 14 days * Autoimmune disease (e.g., Lupus, Multiple Sclerosis) * Any medical condition, which in the opinion of the Investigator, renders participation unsuitable * Undergone pharmacologic cardioversion or external defibrillation within 24 hours of randomization. * Experienced cardiac arrest more than 36 hours after presentation to site or within 24 hours of randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3 | Baseline, Month 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular End Systolic Volume | 6 months | — |
| Infarct Size | 3 and 6 months | — |
| Left Ventricular Ejection Fraction | 3 and 6 months | — |
| Left Ventricular End Diastolic Volume | 3 and 6 months | — |
| Number of Participants with Ventricular Arrhythmias | 3 and 6 months | — |
| Duke Activity Status Index (DASI) Assessment | 6, 12, and 24 months | The Duke Activity Status Index (DASI) is a brief, self-administered questionnaire that provides a standardized assessment of functional status and quality-of-life that correlates well with an objective measure of maximal exercise capacity. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores indicate a greater ability to perform daily activities. |
| New York Heart Association (NYHA) Congestive Heart Failure Classification Status | 6, 12, 24, and 60 months | — |
| Maximal Symptom-limited Exercise Test (Treadmill) | 6 and 12 months | — |
| Number of Participants with Major Adverse Cardiac Events (MACE) | 6, 12, 24, and 60 months | — |
| Overall Survival | 60 months | — |
| Number of Participants with Adverse Events | 3,6,12,24,60 months | — |
Countries
Canada, United States
Contacts
STUDY_DIRECTORKen Borow, MD
Mesoblast, Inc.
Outcome results
None listed