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

April 7, 2009
July 2, 2012
March 2009
December 2011   (final data collection date for primary outcome measure)
Left ventricular end systolic volume (ESV) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00877903 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
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

The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • Drug: Prochymal®
    Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
  • Drug: Placebo
    Intravenous infusion of excipients of Prochymal®
  • Experimental: Prochymal®
    Intervention: Drug: Prochymal®
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
February 2016
December 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00877903
403
Not Provided
Robin Flannery, Osiris Therapeutics
Osiris Therapeutics
Not Provided
Not Provided
Osiris Therapeutics
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP