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Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
ClinicalTrials.gov Identifier:
NCT00877903
First received: April 7, 2009
Last updated: August 29, 2017
Last verified: August 2017
April 7, 2009
August 29, 2017
March 2009
December 2011   (Final data collection date for primary outcome measure)
Left ventricular end systolic volume [ Time Frame: 3 months ]
Left ventricular end systolic volume (ESV)
Complete list of historical versions of study NCT00877903 on ClinicalTrials.gov Archive Site
  • Left ventricular end systolic volume [ Time Frame: 6 months ]
  • Infarct size [ Time Frame: 3 and 6 months ]
  • Left ventricular ejection fraction [ Time Frame: 3 and 6 months ]
  • Left ventricular end diastolic volume [ Time Frame: 3 and 6 months ]
  • Incidence of ventricular arrhythmias [ Time Frame: 3 and 6 months ]
  • Cardiovascular disease-specific quality of life (DASI) assessment [ Time Frame: 6, 12, and 24 months ]
  • NYHA congestive heart failure classification status [ Time Frame: 6, 12, 24, and 60 months ]
  • Maximal symptom-limited exercise test (treadmill) [ Time Frame: 6 and 12 months ]
  • MACE endpoints [ Time Frame: 6, 12, 24, and 60 months ]
  • Survival Status [ Time Frame: 60 months ]
  • Adverse Event [ Time Frame: 3,6,12,24,60 months ]
  • Left ventricular ejection fraction (LVEF)
  • Infarct size
  • Major adverse cardiovascular events (MACE)
Not Provided
Not Provided
 
Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
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
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
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 patients will reach the hospital within the time-window for myocardial rescue. Thus, even if the patient manages their tobacco use, hypertension, lipid levels, diabetes, weight and exercise, many patients 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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • Drug: Prochymal®
    Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
    Other Name: PROCHYMAL
  • Drug: Placebo
    Intravenous infusion of excipients of Prochymal®
  • Experimental: Prochymal®
    200M Mesenchymal Stem Cell (MSC) administered via IV infusion
    Intervention: Drug: Prochymal®
  • Placebo Comparator: Placebo
    Placebo via IV infusion
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
August 2016
December 2011   (Final data collection date for primary outcome measure)

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 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.
Sexes Eligible for Study: All
21 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00877903
403
Yes
Not Provided
Not Provided
Mesoblast, Ltd. ( Mesoblast International Sàrl )
Mesoblast International Sàrl
Not Provided
Study Director: Donna Skerrett, MD Mesoblast, Inc.
Mesoblast, Ltd.
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP