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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Osiris Therapeutics
ClinicalTrials.gov Identifier:
NCT00877903
First received: April 7, 2009
Last updated: July 2, 2012
Last verified: July 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Osiris Therapeutics:

Primary Outcome Measures:
  • Left ventricular end systolic volume (ESV) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 220
Study Start Date: March 2009
Estimated Study Completion Date: February 2016
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prochymal® Drug: Prochymal®
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
Placebo Comparator: Placebo 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

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between 21 and 85 years old
  • First heart attack within 7 days
  • Baseline LVEF 20-45%

Exclusion Criteria:

  • Previous heart attack
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Miami
Miami, Florida, United States, 33136
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
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 / Baptist Memorial Hospital
Germantown / Memphis, 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
Osiris Therapeutics
  More Information

No publications provided

Responsible Party: Robin Flannery, Osiris Therapeutics
ClinicalTrials.gov Identifier: NCT00877903     History of Changes
Other Study ID Numbers: 403
Study First Received: April 7, 2009
Last Updated: July 2, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Osiris Therapeutics:
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

ClinicalTrials.gov processed this record on August 28, 2014