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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 : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Tracking Information
First Submitted Date  ICMJE April 7, 2009
First Posted Date  ICMJE April 8, 2009
Last Update Posted Date January 13, 2022
Actual Study Start Date  ICMJE March 30, 2009
Actual Primary Completion Date May 18, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2020)
Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3 [ Time Frame: Baseline, Month 3 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2009)
Left ventricular end systolic volume (ESV)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
  • 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 ]
  • Number of Participants with Ventricular Arrhythmias [ Time Frame: 3 and 6 months ]
  • Duke Activity Status Index (DASI) Assessment [ Time Frame: 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.
  • New York Heart Association (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 ]
  • Number of Participants with Major Adverse Cardiac Events (MACE) [ Time Frame: 6, 12, 24, and 60 months ]
  • Overall Survival [ Time Frame: 60 months ]
  • Number of Participants with Adverse Events [ 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 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.
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: Remestemcel-L
  • Drug: Placebo
    Intravenous infusion of excipients of Prochymal®
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Prochymal®
  • Placebo Comparator: 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.
    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 March 14, 2016
Actual Primary Completion Date May 18, 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 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.
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mesoblast, Ltd. ( Mesoblast, Inc. )
Original Responsible Party Candy Lee, Ph.D., Osiris Therapeutics
Current Study Sponsor  ICMJE Mesoblast, Inc.
Original Study Sponsor  ICMJE Osiris Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ken Borow, MD Mesoblast, Inc.
PRS Account Mesoblast, Ltd.
Verification Date January 2022

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