A Prospective Randomized Double Blind Placebo Controlled Phase II Trial of Intra-coronary Infusion of AMR-001, a Bone Marrow Derived Autologous CD34+ Selected Cell Product, in Patients With Acute Myocardial Infarction.
Efficacy endpoint is at 6 months. Clinical endpoints and safety will be measured through 36
months.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To determine safety and the effect of intracoronary infusion of AMR-001 on myocardial perfusion (RTSS), measured by gated SPECT MPI at baseline and six months in subjects post-STEMI
primary endpoint includes safety of bone marrow procurement (measured by adverse events) and AMR-001 cell infusion (including incidence of re-stenosis and stent thrombosis in addition to other adverse events)as well as efficacy measured by quantitative by gated SPECT MPI specifically looking at resting total severity score)
primary outcome measured at 6 months
Yes
Tom Moss, MD
Study Director
Amorcyte, Inc.
United States: Food and Drug Administration
002
NCT01495364
December 2011
June 2016
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Mayo Clinic | Rochester, Minnesota 55905 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
University of Medicine and Dentistry of New Jersey | Newark, New Jersey 07103-2425 |
University of Texas Health Science Center at Houston | Houston, Texas 77225 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Miriam Hospital | Providence, Rhode Island 02906 |
Northwestern University | Chicago, Illinois 60611 |
Henry Ford Health Systems | Detroit, Michigan 48202 |
Ohio State University Medical Center | Columbus, Ohio 43210 |
Kansas University Medical Center | Kansas City,, Kansas 66160-7390 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
University of Alabama Birmingham | Birmingham, Alabama 35233 |
Mayo Clinic - Arizona | Scottsdale, Arizona 85259 |
University of Pittsburg Medical Center | Pittsburg, Pennsylvania 15213 |
University of Utah Hospital | Salt Lake City, Utah 84113 |
MetroWest Medical Center | Framingham, Massachusetts 01702 |
Texas Heart Institute | Houston, Texas 77030 |
Keck School of Medicine - University of Southern California | Los Angeles, California 90033 |
Heart Center Research, LLC (Huntsville Hospital) | Huntsville, Alabama 35801 |
Mercy Gilbert Medical Group | Gilbert, Arizona 85297 |
Scripps-La Jolla, CA | La Jolla, California 92037 |
St.Johns Regional Hospital and Medical Center | Oxnard, California 93030 |
Standford University School of Medicine | Stanford, California 94305 |
MedStar Washington Hospital Center | Washington, District of Columbia 20010 |
University of Florida-Gainesville | Gainesville, Florida 32610 |
Orlando Health Medical Center | Orlando, Florida 32806 |
Pepin Heart Institute - Florida Hospital -Tampa | Tampa, Florida 33513 |
St. Joseph's Research Institute | Atlanta, Georgia 30342 |
Emory University Medical Center | Atlanta, Georgia 30322 |
Advocate Health and Hospital Corp. | Downer's Grove, Illinois 60515 |
St. Vincent's Medical Group/St. Vincent's Heart Center of Indiana | Indianapolis, Indiana 46260 |
University of Kentucky, Gill Heart Institute | Lexington, Kentucky 40536 |
Louisville Cardiology Medical Group | Louisville, Kentucky 40207 |
University of Maryland Med Center, Baltimore | Baltimore, Maryland 21201 |
Detroit Medical Center | Detroit, Michigan 48201 |
Detroit Clinical Research Center PC | Farmington Hills, Michigan 48334 |
Minneapolis Heart Institute | Minneapolis, Minnesota 55407 |
Cardiology Asociates Research LLC | Tupelo, Mississippi 38801 |
Maimonides Medical Center-Brooklyn | Brooklyn, New York 11219 |
Buffalo General Medical Center/Roswell Park Cancer Institute | Buffalo, New York 14203 |
Stony Brook University Hospital and Medical Center | Stony Brook, New York 11794-8167 |
Presbyterian CVI Research | Charlotte, North Carolina 28024 |
CaroMont Heart | Gastonia, North Carolina 28054 |
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital | Cincinnati, Ohio 45219 |
Mercy Hospital | Fairfield, Ohio 45014 |
University of Oklahoma Health and Sciences Center | Oaklahoma City, Oklahoma 73104 |
Drexel University/Hahnemann University Medical Center | Philadelphia, Pennsylvania 19102 |
Stern Cardiovascular Foundation/Baptist Hospital | Memphis, Tennessee 38138 |
Austin Heart | Austin, Texas 78756 |
University of Texas Medical Branch - Galveston | Galveston, Texas 77555 |
Methodist Health Systems of San Antonio | San Antonio, Texas 78229 |
UVA Health System Cardiology Research | Charlottesville, Virginia 22908 |
Centra Lynchburg General Hospital | Lynchburg, Virginia 25401 |
Swedish Medical Center-Seattle | Seattle, Washington 98122 |
Aurora Health Care Metro, Inc/St. Lukes Medical Center | Milwaukee, Wisconsin 53233 |