Trial record 1 of 9 for:    AMR-001
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AMR-001 Versus Placebo Post ST Segment Elevation Myocardial Infarction (PreSERVE-AMI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amorcyte, Inc.
ClinicalTrials.gov Identifier:
NCT01495364
First received: December 9, 2011
Last updated: December 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
ST Segment Elevation Myocardial Infarction
Biological: AMR-001
Other: placebo
Phase 2

Study Type: 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
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Amorcyte, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: primary outcome measured at 6 months ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 160
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMR-001
active treatment - CD34+ cells
Biological: AMR-001
dosage = 10 or more million CD34+ cells via intracoronary infusion
Placebo Comparator: placebo
matching placebo
Other: placebo
matching placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495364

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Heart Center Research, LLC (Huntsville Hospital)
Huntsville, Alabama, United States, 35801
United States, Arizona
Mercy Gilbert Medical Group
Gilbert, Arizona, United States, 85297
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
United States, California
Scripps-La Jolla, CA
La Jolla, California, United States, 92037
Keck School of Medicine - University of Southern California
Los Angeles, California, United States, 90033
St.Johns Regional Hospital and Medical Center
Oxnard, California, United States, 93030
Standford University School of Medicine
Stanford, California, United States, 94305
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida-Gainesville
Gainesville, Florida, United States, 32610
Orlando Health Medical Center
Orlando, Florida, United States, 32806
Pepin Heart Institute - Florida Hospital -Tampa
Tampa, Florida, United States, 33513
United States, Georgia
St. Joseph's Research Institute
Atlanta, Georgia, United States, 30342
Emory University Medical Center
Atlanta, Georgia, United States, 30322
Northeast Georgia Heart Center
Gainesville, Georgia, United States, 30501
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Advocate Health and Hospital Corp.
Downer's Grove, Illinois, United States, 60515
Advocate Health and Hospital Corp.
Elmhurst, Illinois, United States, 60126
United States, Indiana
St. Vincent's Medical Group/St. Vincent's Heart Center of Indiana
Indianapolis, Indiana, United States, 46260
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky, Gill Heart Institute
Lexington, Kentucky, United States, 40536
Louisville Cardiology Medical Group
Louisville, Kentucky, United States, 40207
United States, Maryland
University of Maryland Med Center, Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Metrowest Medical Center
Framingham, Massachusetts, United States, 01702
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
Detroit Medical Center
Detroit, Michigan, United States, 48201
Detroit Clinical Research Center PC
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
Cardiology Asociates Research LLC
Tupelo, Mississippi, United States, 38801
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States, 07103
United States, New York
Maimonides Medical Center-Brooklyn
Brooklyn, New York, United States, 11219
Buffalo General Medical Center/Roswell Park Cancer Institute
Buffalo, New York, United States, 14203
Stony Brook University Hospital and Medical Center
Stony Brook, New York, United States, 11794-8167
Westchester Medical Center
Valhalla, New York, United States, 10532
United States, North Carolina
Presbyterian CVI Research
Charlotte, North Carolina, United States, 28024
CaroMont Heart
Gastonia, North Carolina, United States, 28054
United States, Ohio
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital
Cincinnati, Ohio, United States, 45219
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma Health and Sciences Center
Oaklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Drexel University/Hahnemann University Medical Center
Philadelphia, Pennsylvania, United States, 19102
University of PIttsburg Medical Center
Pittsburg, Pennsylvania, United States, 15213
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02904
United States, Tennessee
Stern Cardiovascular Foundation/Baptist Hospital
Memphis, Tennessee, United States, 38138
United States, Texas
Austin Heart
Austin, Texas, United States, 78756
University of Texas Medical Branch - Galveston
Galveston, Texas, United States, 77555
Texas Heart Institute
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Methodist Health Systems of San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
United States, Virginia
UVA Health System Cardiology Research
Charlottesville, Virginia, United States, 22908
Centra Lynchburg General Hospital
Lynchburg, Virginia, United States, 25401
United States, Wisconsin
Aurora Health Care Metro, Inc/St. Lukes Medical Center
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
Amorcyte, Inc.
Investigators
Study Director: Tom Moss, MD Amorcyte, Inc.
Principal Investigator: Arshed Quyyumi, MD Emory University
  More Information

No publications provided

Responsible Party: Amorcyte, Inc.
ClinicalTrials.gov Identifier: NCT01495364     History of Changes
Other Study ID Numbers: 002
Study First Received: December 9, 2011
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amorcyte, Inc.:
STEMI

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on October 19, 2014