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| Sponsor: | Athersys, Inc |
|---|---|
| Collaborators: |
PPD Angiotech Pharmaceuticals |
| Information provided by (Responsible Party): | Athersys, Inc |
| ClinicalTrials.gov Identifier: | NCT00677222 |
Purpose
The purpose of this study is to determine if escalating doses of AMI MultiStem® delivered by catheter can safely be given to patients that have had a recent heart attack treated with stent implantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myocardial Infarction |
Biological: AMI MultiStem® |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Multicenter, Dose-Escalation Trial Evaluating the Safety of Allogeneic AMI MultiStem® in Patients With Acute Myocardial Infarction |
| Enrollment: | 25 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | February 2012 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Treatment arm
|
Biological: AMI MultiStem®
AMI MultiStem® administered via catheter into peri-vascular space of the target vessel, 2-5 days post PCI. There will be 3 dose escalation cohorts, 6 patients per cohort.
|
|
No Intervention: 2
Registry Arm -standard of care
|
The mortality rates associated with acute myocardial infarction (AMI) have significantly decreased over the past 2 decades. Beginning first with thrombolytic therapy for AMI, and more recently with growing acceptance and availability of primary percutaneous coronary intervention (PCI) for ST-elevation AMI, the mortality rates of this devastating ischemic event have decreased from almost 15% in clinical trials in the late 1980's to <5% in recent primary percutaneous coronary intervention trials. Though AMI-related mortality has been reduced, AMI survival is often accompanied by significant loss of function that may lead to subsequent treatments, congestive heart failure (CHF) and reduction in quality of life. A cell therapy that could reduce the damage associated with AMI and positively affect heart function would provide substantial benefits to the AMI patient.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Cardiology PC | |
| Birmingham, Alabama, United States, 35211 | |
| United States, Indiana | |
| The Care Group | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| Metro Health | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Pennsylvania | |
| Hamot Medical Center | |
| Erie, Pennsylvania, United States, 16507 | |
| Principal Investigator: | Marc Penn, MD | The Cleveland Clinic |
| Principal Investigator: | Warren Sherman, MD | Columbia University |
More Information
| Responsible Party: | Athersys, Inc |
| ClinicalTrials.gov Identifier: | NCT00677222 History of Changes |
| Other Study ID Numbers: | AMI-07-001 |
| Study First Received: | May 12, 2008 |
| Last Updated: | January 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Myocardial Infarction, Heart Attack |
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |