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

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ClinicalTrials.gov Identifier: NCT00877903
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : January 13, 2022
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

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
Myocardial Infarction Drug: Prochymal® Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
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 : March 30, 2009
Actual Primary Completion Date : May 18, 2011
Actual Study Completion Date : March 14, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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 Name: 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®

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

Secondary Outcome Measures :
  1. Left Ventricular End Systolic Volume [ Time Frame: 6 months ]
  2. Infarct Size [ Time Frame: 3 and 6 months ]
  3. Left Ventricular Ejection Fraction [ Time Frame: 3 and 6 months ]
  4. Left Ventricular End Diastolic Volume [ Time Frame: 3 and 6 months ]
  5. Number of Participants with Ventricular Arrhythmias [ Time Frame: 3 and 6 months ]
  6. 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.

  7. New York Heart Association (NYHA) Congestive Heart Failure Classification Status [ Time Frame: 6, 12, 24, and 60 months ]
  8. Maximal Symptom-limited Exercise Test (Treadmill) [ Time Frame: 6 and 12 months ]
  9. Number of Participants with Major Adverse Cardiac Events (MACE) [ Time Frame: 6, 12, 24, and 60 months ]
  10. Overall Survival [ Time Frame: 60 months ]
  11. Number of Participants with Adverse Events [ Time Frame: 3,6,12,24,60 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
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.

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

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Sponsors and Collaborators
Mesoblast, Inc.
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Study Director: Ken Borow, MD Mesoblast, Inc.
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Responsible Party: Mesoblast, Inc.
ClinicalTrials.gov Identifier: NCT00877903    
Other Study ID Numbers: 403
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mesoblast, Ltd. ( Mesoblast, Inc. ):
Acute myocardial infarction
Myocardial infarction
Heart attack
Mesenchymal stem cells
Adult human stem cells
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents