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

Tracking Information
First Received Date ^ICMJE	April 7, 2009
Last Updated Date	July 2, 2012
Start Date ^ICMJE	March 2009
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 7, 2009)	Left ventricular end systolic volume (ESV) [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00877903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 7, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
Official Title ^ICMJE	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
Brief Summary	The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Myocardial Infarction
Intervention ^ICMJE	Drug: Prochymal® Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells Drug: Placebo Intravenous infusion of excipients of Prochymal®
Study Arm (s)	Experimental: Prochymal® Intervention: Drug: Prochymal® Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	220
Estimated Completion Date	February 2016
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	21 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00877903
Other Study ID Numbers ^ICMJE	403
Has Data Monitoring Committee	Not Provided
Responsible Party	Robin Flannery, Osiris Therapeutics
Study Sponsor ^ICMJE	Osiris Therapeutics
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Osiris Therapeutics
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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