AMR-001 Versus Placebo Post ST Segment Elevation Myocardial Infarction



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/30/2013
Start Date:December 2011
End Date:June 2016
Contact:Tom Moss, MD
Email:tjmdsm@ix.netcom.com
Phone:818-903-4036

Use our guide to learn which trials are right for you!

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.


This study will assess the safety and efficacy of intracoronary artery administered
autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial
infarction (STEMI). Efficacy will be assessed by evaluating and comparing the autologous
stem cell treatment group to the control group via change in myocardial perfusion (RTSS)
measured quantitatively by gated single photon emission computed tomography myocardial
perfusion imaging (gated SPECT MPI) among other secondary endpoints measured by cardiac MRI
in addition to clinical endpoints.


Efficacy endpoint is at 6 months. Clinical endpoints and safety will be measured through 36
months.

Inclusion Criteria:

1. Age 18 years or older.

2. Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of
chest pain within 3 days of admission. Criteria include (ST elevation > 1mm in limb
leads or 2 mm in two or more precordial leads, and increased levels of troponin, CPK
MB or both).

Chest pain syndrome can extend to more than 3 days prior to admission if its course
is consistent with transient/intermittent ischemia rather than symptoms that are
continuous suggesting ongoing infarction extending beyond 3 days.

3. Successful stent placement and reperfusion within 3 days of chest pain onset and with
TIMI Flow score of 2 or 3 and infarct related artery (IRA) with <20% stenosis after
revascularization.

4. Wall motion abnormality associated with the target lesion

5. NYHA heart failure class I, II or III.

6. Study entry LVEF <48% determined by CMR no sooner than 96 hours from stent placement.

7. Able to provide informed written consent and willing to participate in all required
study follow-up assessments.

8. Subjects must have an INR ≤ 2.0 within 2 days of the bone marrow collection.

9. Subjects must have a Hgb ≥ 10 grams/dL, WBC ≥ 3500 cells/mm3, a platelet count ≥
100,000 cells/mm3, serum creatinine ≤ 2.5, and total bilirubin ≤ 2.0 within 7 days of
the bone marrow collection or by end of screening phase.

10. Expected survival of at least one year.

11. Females of child bearing potential agree to use birth control (barrier method
accepted) for one month post bone marrow harvest.

EXCLUSION CRITERIA

1. Continuous/ongoing chest pain - unremitting and unresponsive to nitroglycerin or rest
- persisting 4 or more days before stent placement. If the chest pain syndrome is
transient and/or intermittent - even if it began more than 3 days prior to admission
- the patient is not excluded.

2. Subjects in cardiogenic shock (systolic pressure < 80mm/Hg, on vasopressors, or
intra-aortic counterpulsation) at the time of consenting. Subjects who recover from
cardiogenic shock by the time of consenting are eligible.

3. Subjects unable to receive antiplatelet agents (e.g. aspirin, clopidogrel,
ticlopidine, prasugrel, etc).

4. Subjects receiving warfarin who have an INR >2 or with major bleeding requiring
active transfusion support.

5. Subjects who require continuous anticoagulation during the time when the bone marrow
harvest is scheduled, as heparin must be discontinued for 4 hours prior to and 24
hours after bone marrow harvest procedure. (See Appendix VII.)

6. Subjects with severe cardiac valvular disease expected to undergo surgery within 1
year.

7. Subjects with known severe immunodeficiency states (AIDS).

8. Cirrhosis requiring active medical management.

9. Malignancy requiring active treatment (except basal cell skin cancer).

10. Subjects with documented active alcohol and /or other substance abuse.

11. Females of child bearing potential unless a pregnancy test is negative within 7 days
of the mini-bone marrow harvest.

12. Re-occlusion of the IRA prior to the infusion procedure.

13. Planned revascularization intervention during the next 6 months (A second PCI can be
performed if done prior to qualifying CMR at least 96 hours post primary PCI).

14. Participation in an ongoing investigational trial.

15. Active or suspected bacterial infection requiring systemic intravenous antibiotics.
We found this trial at
60
sites
100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
?
mi
from
Danville, PA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Gainesville, Florida 32611
(352) 392-3261
University of Florida Gainesville UF has a long history of established programs in international education,...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch at Galveston Established in 1891 as the University of Texas...
?
mi
from
Galveston, TX
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78756
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Brooklyn, New York 11219
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Canton, Ohio
?
mi
from
Canton, OH
Click here to add this to my saved trials
Charlotte, North Carolina 28024
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Downer's Grove, Illinois 60515
?
mi
from
Downer's Grove, IL
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
Framingham, Massachusetts 01702
?
mi
from
Framingham, MA
Click here to add this to my saved trials
Gainesville, Georgia
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
Gastonia, North Carolina 28054
?
mi
from
Gastonia, NC
Click here to add this to my saved trials
Gilbert, Arizona 85297
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Houston, Texas 77225
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kansas City, Kansas
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lynchburg, Virginia 25401
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55407
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Oaklahoma City, Oklahoma 73104
?
mi
from
Oaklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Oxnard, CA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85054
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15260
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
?
mi
from
Providence, RI
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Seattle, Washington 98122
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Tupelo, Mississippi 38801
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
Valhalla, New York 10595
?
mi
from
Valhalla, NY
Click here to add this to my saved trials
Washington, District of Columbia
?
mi
from
Washington,
Click here to add this to my saved trials