Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
- Conditions
- Myocardial Infarction
- Interventions
- Drug: PlaceboDrug: Prochymal®
- Registration Number
- NCT00877903
- Lead Sponsor
- Mesoblast, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive Prochymal® placebo-matching single IV infusion at a dose of of 200 x 10\^6 hMSC, reconstituted in 80 mL, delivered at a rate of 2 mL/min, with a maximum rate of 5.0 x 10\^6 hMSC/minute, and the participants will be followed for 24 months and remain in the study for up to 60 months. Prochymal® Prochymal® Participants will receive Prochymal® single intravenous (IV) infusion at a dose of 200 x 10\^6 human mesenchymal stem cells (hMSC), reconstituted in 80 mL, delivered at a rate of 2 mL/min, with a maximum rate of 5.0 x 10\^6 hMSC/minute, and the participants will be followed for 24 months and remain in the study for up to 60 months.
- Primary Outcome Measures
Name Time Method Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3 Baseline, Month 3
- Secondary Outcome Measures
Name Time Method Infarct Size 3 and 6 months Left Ventricular Ejection Fraction 3 and 6 months Left Ventricular End Diastolic Volume 3 and 6 months Left Ventricular End Systolic Volume 6 months Overall Survival 60 months 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 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.
Number of Participants with Major Adverse Cardiac Events (MACE) 6, 12, 24, and 60 months Number of Participants with Adverse Events 3,6,12,24,60 months
Trial Locations
- Locations (33)
Mercy Gilbert Medical Center / Catholic Health Care West
🇺🇸Gilbert, Arizona, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
University of Miami
🇺🇸Miami, Florida, United States
University of Texas Health Science Center
🇺🇸Houston, Texas, United States
University of California - San Diego (UCSD)
🇺🇸San Diego, California, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The Care Group
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University at Buffalo - Buffalo General Hospital
🇺🇸Buffalo, New York, United States
The Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
Cotton-O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
The Stern Cardiovascular Center
🇺🇸Germantown, Tennessee, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Wisconsin School of Medicine
🇺🇸Madison, Wisconsin, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Michigan Cardiovascular Institute
🇺🇸Saginaw, Michigan, United States
Penn State University - Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Austin Heart P.A.
🇺🇸Austin, Texas, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Maryland Hospital
🇺🇸Baltimore, Maryland, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States