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 |
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
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
Click here to add this to my saved trials
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
Click here to add this to my saved trials
University of Florida Gainesville UF has a long history of established programs in international education,...
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch at Galveston Established in 1891 as the University of Texas...
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials
University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
Click here to add this to my saved trials
Cincinnati, Ohio 45219
Click here to add this to my saved trials
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
Click here to add this to my saved trials
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
Click here to add this to my saved trials
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials