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| Sponsor: | Athersys, Inc |
|---|---|
| Collaborators: |
PPD Angiotech Pharmaceuticals |
| Information provided by: | 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: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
| Official Title: | A Phase I, Multicenter, Dose-Escalation Trial Evaluating the Safety of Allogeneic AMI MultiStem® in Patients With Acute Myocardial Infarction |
| Estimated Enrollment: | 28 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
|
2: No Intervention
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| Contact: Cheryl A Graveen, BS | 216-269-4880 | cgraveen@athersys.com |
| Contact: Anthony Ting, PhD | 216-431-9900 ext 329 | ating@athersys.com |
| United States, Alabama | |
| Cardiology PC | Recruiting |
| Birmingham, Alabama, United States, 35211 | |
| Contact: Susan DeRamus 205-780-4330 ext 338 sderamus@cardiologypc.com | |
| Principal Investigator: Farrell Mendelsohn, MD | |
| United States, Indiana | |
| The Care Group | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Anne Taylor, BSN 317-583-6319 ataylor@thecaregroup.com | |
| Principal Investigator: Zachary Hodes, MD | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Julianne Longlade 313-916-3498 JLONGLA1@hfhs.org | |
| Principal Investigator: Adam Greenbaum, MD | |
| University of Michigan Health Systems | Terminated |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Sunil Kanwal, MD 212-342-5128 sk3039@Columbia.edu | |
| Principal Investigator: Warren Sherman, MD | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Sonya Reddick 216-445-7840 reddics@ccf.org | |
| Principal Investigator: Marc Penn, MD | |
| Nothern Ohio Heart Center | Terminated |
| Elyria, Ohio, United States, 44035 | |
| Metro Health | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Mary Dettmer 216-778-2223 mdettmer@metrohealth.org | |
| Principal Investigator: Sanjay Gandhi, MD | |
| United States, Pennsylvania | |
| Hamot Medical Center | Recruiting |
| Erie, Pennsylvania, United States, 16507 | |
| Contact: Patty Henry 814-877-3635 Patty.Henry@hamot.org | |
| Principal Investigator: David Strasser, MD | |
| Principal Investigator: | Marc Penn, MD | Cleveland Clinic |
| Principal Investigator: | Warren Sherman, MD | Columbia University |
More Information
| Responsible Party: | Athersys, Inc. ( Anthony Ting, Ph.D. ) |
| Study ID Numbers: | AMI-07-001 |
| Study First Received: | May 12, 2008 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00677222 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Myocardial Infarction, Heart Attack |
|
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |