Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI) - Full Text View

Sponsor:	Osiris Therapeutics
Information provided by:	Osiris Therapeutics
ClinicalTrials.gov Identifier:	NCT00877903

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 II

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 2013
Estimated 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:	March 9, 2011
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 February 07, 2012