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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
History of Changes
  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:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877903

  Show 33 Study Locations
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 May 21, 2013