Clinical trial NCT00877903: Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
Official title: A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL® (Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction
Keywords: Acute myocardial infarction
AMI
Myocardial infarction
Heart attack
Mesenchymal stem cells
MSC
Adult human stem cells
Osiris
Lead sponsor: Mesoblast, Ltd.
Sponsor class: INDUSTRY
First posted: 2009-04-08
Enrollment: 220
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Left Ventricular End Systolic Volume
timeFrame: 6 months
measure: Infarct Size
timeFrame: 3 and 6 months
measure: Left Ventricular Ejection Fraction
timeFrame: 3 and 6 months
measure: Left Ventricular End Diastolic Volume
timeFrame: 3 and 6 months
measure: Number of Participants with Ventricular Arrhythmias
timeFrame: 3 and 6 months
measure: Duke Activity Status Index (DASI) Assessment
timeFrame: 6, 12, and 24 months
measure: New York Heart Association (NYHA) Congestive Heart Failure Classification Status
timeFrame: 6, 12, 24, and 60 months
measure: Maximal Symptom-limited Exercise Test (Treadmill)
timeFrame: 6 and 12 months
measure: Number of Participants with Major Adverse Cardiac Events (MACE)
timeFrame: 6, 12, 24, and 60 months
measure: Overall Survival
timeFrame: 60 months
measure: Number of Participants with Adverse Events
timeFrame: 3,6,12,24,60 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center / Catholic Health Care West
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Diego
country: United States
facility: University of California - San Diego (UCSD)
state: California
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saginaw
country: United States
facility: Michigan Cardiovascular Institute
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: New Brunswick
country: United States
facility: UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo - Buffalo General Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State University - Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Germantown
country: United States
facility: The Stern Cardiovascular Center
state: Tennessee
city: Austin
country: United States
facility: Austin Heart P.A.
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Madison
country: United States
facility: University of Wisconsin School of Medicine
state: Wisconsin
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Mesoblast, Inc.
name: Ken Borow, MD
role: STUDY_DIRECTOR
References: