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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
N/A
Open (Enrolling)
Both
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
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.

Type of Study:

Interventional

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:

Yes

Principal Investigator

Tom Moss, MD

Investigator Role:

Study Director

Investigator Affiliation:

Amorcyte, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

002

NCT ID:

NCT01495364

Start Date:

December 2011

Completion Date:

June 2016

Related Keywords:

  • ST Segment Elevation Myocardial Infarction
  • STEMI
  • Infarction
  • Myocardial Infarction

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