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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 MichiganAnn Arbor, Michigan  48109-0624
Mayo ClinicRochester, Minnesota  55905
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Rush University Medical CenterChicago, Illinois  60612-3824
Hackensack University Medical CenterHackensack, New Jersey  07601
University of Medicine and Dentistry of New JerseyNewark, New Jersey  07103-2425
University of Texas Health Science Center at HoustonHouston, Texas  77225
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Miriam HospitalProvidence, Rhode Island  02906
Northwestern UniversityChicago, Illinois  60611
Henry Ford Health SystemsDetroit, Michigan  48202
Ohio State University Medical CenterColumbus, Ohio  43210
Kansas University Medical CenterKansas City,, Kansas  66160-7390
University of CincinnatiCincinnati, Ohio  45267-0502
University of Alabama BirminghamBirmingham, Alabama  35233
Mayo Clinic - ArizonaScottsdale, Arizona  85259
University of Pittsburg Medical CenterPittsburg, Pennsylvania  15213
University of Utah HospitalSalt Lake City, Utah  84113
MetroWest Medical CenterFramingham, Massachusetts  01702
Texas Heart InstituteHouston, Texas  77030
Keck School of Medicine - University of Southern CaliforniaLos Angeles, California  90033
Heart Center Research, LLC (Huntsville Hospital)Huntsville, Alabama  35801
Mercy Gilbert Medical GroupGilbert, Arizona  85297
Scripps-La Jolla, CALa Jolla, California  92037
St.Johns Regional Hospital and Medical CenterOxnard, California  93030
Standford University School of MedicineStanford, California  94305
MedStar Washington Hospital CenterWashington, District of Columbia  20010
University of Florida-GainesvilleGainesville, Florida  32610
Orlando Health Medical CenterOrlando, Florida  32806
Pepin Heart Institute - Florida Hospital -TampaTampa, Florida  33513
St. Joseph's Research InstituteAtlanta, Georgia  30342
Emory University Medical CenterAtlanta, Georgia  30322
Advocate Health and Hospital Corp.Downer's Grove, Illinois  60515
St. Vincent's Medical Group/St. Vincent's Heart Center of IndianaIndianapolis, Indiana  46260
University of Kentucky, Gill Heart InstituteLexington, Kentucky  40536
Louisville Cardiology Medical GroupLouisville, Kentucky  40207
University of Maryland Med Center, BaltimoreBaltimore, Maryland  21201
Detroit Medical CenterDetroit, Michigan  48201
Detroit Clinical Research Center PCFarmington Hills, Michigan  48334
Minneapolis Heart InstituteMinneapolis, Minnesota  55407
Cardiology Asociates Research LLCTupelo, Mississippi  38801
Maimonides Medical Center-BrooklynBrooklyn, New York  11219
Buffalo General Medical Center/Roswell Park Cancer InstituteBuffalo, New York  14203
Stony Brook University Hospital and Medical CenterStony Brook, New York  11794-8167
Presbyterian CVI ResearchCharlotte, North Carolina  28024
CaroMont HeartGastonia, North Carolina  28054
The Carl and Edyth Lindner Center for Research and Education at the Christ HospitalCincinnati, Ohio  45219
Mercy HospitalFairfield, Ohio  45014
University of Oklahoma Health and Sciences CenterOaklahoma City, Oklahoma  73104
Drexel University/Hahnemann University Medical CenterPhiladelphia, Pennsylvania  19102
Stern Cardiovascular Foundation/Baptist HospitalMemphis, Tennessee  38138
Austin HeartAustin, Texas  78756
University of Texas Medical Branch - GalvestonGalveston, Texas  77555
Methodist Health Systems of San AntonioSan Antonio, Texas  78229
UVA Health System Cardiology ResearchCharlottesville, Virginia  22908
Centra Lynchburg General HospitalLynchburg, Virginia  25401
Swedish Medical Center-SeattleSeattle, Washington  98122
Aurora Health Care Metro, Inc/St. Lukes Medical CenterMilwaukee, Wisconsin  53233