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View Clinical Trial (Medical Research Study)
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Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI) - NCT00877903-33136 (Clinical Trial 395693)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy395693.aspx
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| City: |
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Miami |
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State:
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FL |
| Zip Code: |
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33136 |
| Conditions: |
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Myocardial Infarction |
| Purpose: |
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The objective of the present study is to establish the safety and efficacy of Prochymal®
following first acute myocardial infarction.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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University of Miami
Miami, FL 33136
United States
Primary Contact:
Phillip Gonzalez
Email: PGonzalez3@med.miami.edu
Phone: 305-243-5138
Secondary Contact:
Robin Flannery
Email: rflannery@osiris.com
Phone: 443-545-1818 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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