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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
ClinicalTrials.gov Identifier:
NCT00877903
First received: April 7, 2009
Last updated: September 19, 2016
Last verified: September 2016
  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 Mesoblast, Ltd.:

Primary Outcome Measures:
  • Left ventricular end systolic volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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

  Show 33 Study Locations
Sponsors and Collaborators
Mesoblast International Sàrl
Investigators
Study Director: Lee Golden, MD Mesoblast, Inc.
  More Information

Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT00877903     History of Changes
Other Study ID Numbers: 403 
Study First Received: April 7, 2009
Last Updated: September 19, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Mesoblast, Ltd.:
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 December 05, 2016