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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00877903
First Posted: April 8, 2009
Last Update Posted: August 30, 2017
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.
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
  Purpose
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.

Condition Intervention Phase
Myocardial Infarction Drug: Prochymal® Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):

Primary Outcome Measures:
  • Left ventricular end systolic volume [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 220
Study Start Date: March 2009
Study Completion Date: August 2016
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prochymal®
200M Mesenchymal Stem Cell (MSC) administered via IV infusion
Drug: Prochymal®
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
Other Name: PROCHYMAL
Placebo Comparator: Placebo
Placebo via IV infusion
Drug: Placebo
Intravenous infusion of excipients of Prochymal®

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877903


  Hide Study Locations
Locations
United States, Arizona
Mercy Gilbert Medical Center / Catholic Health Care West
Gilbert, Arizona, United States, 85297
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
University of California - San Diego (UCSD)
San Diego, California, United States, 92103
United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
The Care Group
Indianapolis, Indiana, United States, 46290
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, United States, 66604
United States, Maryland
University of Maryland Hospital
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Michigan Cardiovascular Institute
Saginaw, Michigan, United States, 48601
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, New York
University at Buffalo - Buffalo General Hospital
Buffalo, New York, United States, 14203
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State University - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
The Stern Cardiovascular Center
Germantown, Tennessee, United States, 38138
United States, Texas
Austin Heart P.A.
Austin, Texas, United States, 78756
University of Texas Health Science Center
Houston, Texas, United States, 77030
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Wisconsin
University of Wisconsin School of Medicine
Madison, Wisconsin, United States, 53792
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Mesoblast International Sàrl
Investigators
Study Director: Donna Skerrett, MD Mesoblast, Inc.
  More Information

Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT00877903     History of Changes
Other Study ID Numbers: 403
First Submitted: April 7, 2009
First Posted: April 8, 2009
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
Acute myocardial infarction
AMI
Myocardial infarction
Heart attack
Mesenchymal stem cells
MSC
Adult human stem cells
Osiris

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases