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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00877903
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )

Tracking Information
First Submitted Date  ICMJE April 7, 2009
First Posted Date  ICMJE April 8, 2009
Last Update Posted Date March 22, 2018
Study Start Date  ICMJE March 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
Left ventricular end systolic volume [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2009)
Left ventricular end systolic volume (ESV)
Change History Complete list of historical versions of study NCT00877903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2009)
  • Left ventricular ejection fraction (LVEF)
  • Infarct size
  • Major adverse cardiovascular events (MACE)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
Official Title  ICMJE 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
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Drug: Prochymal®
    Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
    Other Name: PROCHYMAL
  • Drug: Placebo
    Intravenous infusion of excipients of Prochymal®
Study Arms  ICMJE
  • Experimental: Prochymal®
    200M Mesenchymal Stem Cell (MSC) administered via IV infusion
    Intervention: Drug: Prochymal®
  • Placebo Comparator: Placebo
    Placebo via IV infusion
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2009)
220
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00877903
Other Study ID Numbers  ICMJE 403
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mesoblast, Ltd. ( Mesoblast International Sàrl )
Study Sponsor  ICMJE Mesoblast International Sàrl
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Donna Skerrett, MD Mesoblast, Inc.
PRS Account Mesoblast, Ltd.
Verification Date March 2018

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