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

Sponsor
Mesoblast, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00877903
Collaborator
(none)
220
Enrollment
33
Locations
2
Arms
83.5
Actual Duration (Months)
6.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 30, 2009
Actual Primary Completion Date :
May 18, 2011
Actual Study Completion Date :
Mar 14, 2016

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Prochymal®
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
Other Names:
  • Remestemcel-L

    		•
    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.

    Drug: Placebo
    Intravenous infusion of excipients of Prochymal®

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3 [Baseline, Month 3]

    Secondary Outcome Measures

    1. Left Ventricular End Systolic Volume [6 months]

    2. Infarct Size [3 and 6 months]

    3. Left Ventricular Ejection Fraction [3 and 6 months]

    4. Left Ventricular End Diastolic Volume [3 and 6 months]

    5. Number of Participants with Ventricular Arrhythmias [3 and 6 months]

    6. Duke Activity Status Index (DASI) Assessment [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.

    7. New York Heart Association (NYHA) Congestive Heart Failure Classification Status [6, 12, 24, and 60 months]

    8. Maximal Symptom-limited Exercise Test (Treadmill) [6 and 12 months]

    9. Number of Participants with Major Adverse Cardiac Events (MACE) [6, 12, 24, and 60 months]

    10. Overall Survival [60 months]

    11. Number of Participants with Adverse Events [3,6,12,24,60 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mercy Gilbert Medical Center / Catholic Health Care West Gilbert Arizona United States 85297
    2 University of Arizona Tucson Arizona United States 85724
    3 UC Davis Medical Center Sacramento California United States 95817
    4 University of California - San Diego (UCSD) San Diego California United States 92103
    5 Mount Sinai Medical Center Miami Beach Florida United States 33140
    6 University of Miami Miami Florida United States 33136
    7 Rush University Medical Center Chicago Illinois United States 60612
    8 The Care Group Indianapolis Indiana United States 46290
    9 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    10 Cotton-O'Neil Clinical Research Center Topeka Kansas United States 66604
    11 University of Maryland Hospital Baltimore Maryland United States 21201
    12 Tufts Medical Center Boston Massachusetts United States 02111
    13 Baystate Medical Center Springfield Massachusetts United States 01199
    14 UMass Memorial Medical Center Worcester Massachusetts United States 01655
    15 William Beaumont Hospital Royal Oak Michigan United States 48073
    16 Michigan Cardiovascular Institute Saginaw Michigan United States 48601
    17 Minneapolis Heart Institute Minneapolis Minnesota United States 55407
    18 UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey United States 08903
    19 University at Buffalo - Buffalo General Hospital Buffalo New York United States 14203
    20 Stony Brook University Medical Center Stony Brook New York United States 11794
    21 Wake Forest University School of Medicine Winston-Salem North Carolina United States 27157
    22 The Lindner Research Center Cincinnati Ohio United States 45219
    23 The Ohio State University Medical Center Columbus Ohio United States 43210
    24 Oregon Health & Science University Portland Oregon United States 97239
    25 Penn State University - Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    26 Drexel University College of Medicine Philadelphia Pennsylvania United States 19102
    27 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    28 The Stern Cardiovascular Center Germantown Tennessee United States 38138
    29 Austin Heart P.A. Austin Texas United States 78756
    30 University of Texas Health Science Center Houston Texas United States 77030
    31 Fletcher Allen Health Care Burlington Vermont United States 05401
    32 University of Wisconsin School of Medicine Madison Wisconsin United States 53792
    33 McGill University Health Centre Montreal Quebec Canada H3A 1A1

    Sponsors and Collaborators

    • Mesoblast, Inc.

    Investigators

    • Study Director: Ken Borow, MD, Mesoblast, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mesoblast, Inc.
    ClinicalTrials.gov Identifier:
    NCT00877903
    Other Study ID Numbers:
    • 403
    First Posted:
    Apr 8, 2009
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mesoblast, Inc.
    Acute myocardial infarction
    AMI
    Myocardial infarction
    Heart attack
    Mesenchymal stem cells
    MSC
    Adult human stem cells
    Osiris
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Remestemcel-l

    Study Results

    No Results Posted as of Jan 13, 2022