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| Sponsor: | Osiris Therapeutics |
|---|---|
| Information provided by: | Osiris Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00114452 |
Purpose
The purpose of the study is to determine whether adult stem cells [Provacel™(PUMP1)] are safe and possibly effective in the treatment of acute myocardial infarction (heart attack).
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Drug: Provacel |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Multicenter Study to Determine the Safety of Intravenous Ex-Vivo Cultured Adult Human Mesenchymal Stem Cells (Provacel) Following Acute Myocardial Infarction |
| Estimated Enrollment: | 48 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | September 2006 |
Cardiovascular disease is the single largest killer of males and females in the United States with an average of 335,000 deaths per year. This year an estimated 700,000 Americans will suffer an acute myocardial infarction. The standard of care treatment for acute myocardial infarction (MI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants, Beta-Blockers, nitrates and Ace-inhibitors. Management of cardiac risk factors such as tobacco use, hypertension, lipid levels, diabetes, weight control and exercise all work to reduce further atherosclerotic events. Yet, many patients go on to develop Congestive Heart Failure (CHF). Medical management for CHF may improve symptoms and slow the progression to failure but does not 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 in an area of unmet medical need.
Patients will receive standard of care in addition to stem cells or placebo.
Eligibility| Ages Eligible for Study: | 21 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Arizona Heart Institute | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| University of California - San Diego; Thornton | |
| San Diego, California, United States, 92103-8411 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| The Care Group | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| Jewish Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| Washington Adventist | |
| Takoma Park, Maryland, United States, 20912 | |
| United States, Minnesota | |
| Minneapolis Heart Institute | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New York | |
| Columbia Presbyterian Hospital | |
| New York, New York, United States, 10032 | |
| University of Rochester - Strong Memorial | |
| Rochester, New York, United States, 14642 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| University of Pennsylvania Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Austin Heart Institute | |
| Austin, Texas, United States, 78756 | |
| Texas Medical School | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Seattle Swedish Cardiovascular Institute | |
| Seattle, Washington, United States, 98104 | |
| Principal Investigator: | Joshua Hare, MD | Johns Hopkins University |
More Information
| Study ID Numbers: | 401 |
| Study First Received: | June 14, 2005 |
| Last Updated: | April 3, 2006 |
| ClinicalTrials.gov Identifier: | NCT00114452 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Myocardial Infarction Heart Attack Cardiovascular Disease |
Stem cells Congestive Heart Failure Heart Attack Repair |
|
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |