Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
This study is ongoing, but not recruiting participants.
Sponsor:
Osiris Therapeutics
Information provided by:
Osiris Therapeutics
ClinicalTrials.gov Identifier:
NCT00877903
First received: April 7, 2009
Last updated: July 2, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| 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:
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 2016 |
| 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
Hide Study Locations
Hide Study LocationsLocations
| United States, Arizona | |
| Mercy Gilbert Medical Center / Catholic Health Care West | |
| Gilbert, Arizona, United States, 85297 | |
| University of Arizona | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| UC Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| University of California - San Diego (UCSD) | |
| San Diego, California, United States, 92103 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| The Care Group | |
| Indianapolis, Indiana, United States, 46290 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Cotton-O'Neil Clinical Research Center | |
| Topeka, Kansas, United States, 66604 | |
| United States, Maryland | |
| University of Maryland Hospital | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Tufts Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| UMass Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| Michigan Cardiovascular Institute | |
| Saginaw, Michigan, United States, 48601 | |
| United States, Minnesota | |
| Minneapolis Heart Institute | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New Jersey | |
| UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, New York | |
| University at Buffalo - Buffalo General Hospital | |
| Buffalo, New York, United States, 14203 | |
| Stony Brook University Medical Center | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Wake Forest University School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| The Lindner Research Center | |
| Cincinnati, Ohio, United States, 45219 | |
| The Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Penn State University - Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Tennessee | |
| The Stern Cardiovascular Center / Baptist Memorial Hospital | |
| Germantown / Memphis, Tennessee, United States, 38138 | |
| United States, Texas | |
| Austin Heart P.A. | |
| Austin, Texas, United States, 78756 | |
| University of Texas Health Science Center | |
| Houston, Texas, United States, 77030 | |
| United States, Vermont | |
| Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05401 | |
| United States, Wisconsin | |
| University of Wisconsin School of Medicine | |
| Madison, Wisconsin, United States, 53792 | |
| Canada, Quebec | |
| McGill University Health Centre | |
| Montreal, Quebec, Canada, H3A 1A1 | |
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: | July 2, 2012 |
| 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 May 23, 2013