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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
ClinicalTrials.gov Identifier:
NCT00877903
First received: April 7, 2009
Last updated: October 20, 2014
Last verified: October 2014

April 7, 2009
October 20, 2014
March 2009
December 2011   (final data collection date for primary outcome measure)
Left ventricular end systolic volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Left ventricular end systolic volume (ESV) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00877903 on ClinicalTrials.gov Archive Site
  • Left ventricular end systolic volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Infarct size [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Left ventricular ejection fraction [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Left ventricular end diastolic volume [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Incidence of ventricular arrhythmias [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Cardiovascular disease-specific quality of life (DASI) assessment [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • NYHA congestive heart failure classification status [ Time Frame: 6, 12, 24, and 60 months ] [ Designated as safety issue: No ]
  • Maximal symptom-limited exercise test (treadmill) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • MACE endpoints [ Time Frame: 6, 12, 24, and 60 months ] [ Designated as safety issue: Yes ]
  • Survival Status [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Adverse Event [ Time Frame: 3,6,12,24,60 months ] [ Designated as safety issue: Yes ]
  • Left ventricular ejection fraction (LVEF) [ Designated as safety issue: No ]
  • Infarct size [ Designated as safety issue: No ]
  • Major adverse cardiovascular events (MACE) [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • Drug: Prochymal®
    Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
  • Drug: Placebo
    Intravenous infusion of excipients of Prochymal®
  • Experimental: Prochymal®
    Intervention: Drug: Prochymal®
  • Placebo Comparator: Placebo
    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.
 
Active, not recruiting
220
February 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.
Both
21 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00877903
403
Yes
Mesoblast, Ltd. ( Mesoblast International Sàrl )
Mesoblast International Sàrl
Not Provided
Study Director: Priya Raina Mesoblast, Inc.
Mesoblast, Ltd.
October 2014

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