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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.

Phase 2
18 Years
Open (Enrolling)
ST Segment Elevation Myocardial Infarction

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Trial Information

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

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

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.


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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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)

Outcome Time Frame:

primary outcome measured at 6 months

Safety Issue:


Principal Investigator

Tom Moss, MD

Investigator Role:

Study Director

Investigator Affiliation:

Amorcyte, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

June 2016

Related Keywords:

  • ST Segment Elevation Myocardial Infarction
  • Infarction
  • Myocardial Infarction



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