NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction
NCT ID: NCT01495364
Last Updated: 2016-04-28
Study Results
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Basic Information
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COMPLETED
PHASE2
195 participants
INTERVENTIONAL
2011-12-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NBS10
active treatment - CD34+ cells
NBS10
dosage = 10 or more million CD34+ cells via intracoronary infusion
placebo
matching placebo
placebo
matching placebo
Interventions
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NBS10
dosage = 10 or more million CD34+ cells via intracoronary infusion
placebo
matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Lisata Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tom Moss, MD
Role: STUDY_DIRECTOR
Lisata Therapeutics, Inc.
Arshed Quyyumi, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Heart Center Research, LLC (Huntsville Hospital)
Huntsville, Alabama, United States
Mercy Gilbert Medical Group
Gilbert, Arizona, United States
Mayo Clinic - Arizona
Phoenix, Arizona, United States
Scripps-La Jolla, CA
La Jolla, California, United States
Keck School of Medicine - University of Southern California
Los Angeles, California, United States
St.Johns Regional Hospital and Medical Center
Oxnard, California, United States
Standford University School of Medicine
Stanford, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida-Gainesville
Gainesville, Florida, United States
Orlando Health Medical Center
Orlando, Florida, United States
Pepin Heart Institute - Florida Hospital -Tampa
Tampa, Florida, United States
Emory University Medical Center
Atlanta, Georgia, United States
St. Joseph's Research Institute
Atlanta, Georgia, United States
Northeast Georgia Heart Center
Gainesville, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Advocate Health and Hospital Corp.
Downer's Grove, Illinois, United States
Advocate Health and Hospital Corp.
Elmhurst, Illinois, United States
St. Vincent's Medical Group/St. Vincent's Heart Center of Indiana
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
University of Kentucky, Gill Heart Institute
Lexington, Kentucky, United States
Louisville Cardiology Medical Group
Louisville, Kentucky, United States
University of Maryland Med Center, Baltimore
Baltimore, Maryland, United States
Metrowest Medical Center
Framingham, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Detroit Medical Center
Detroit, Michigan, United States
Henry Ford Health Systems
Detroit, Michigan, United States
Detroit Clinical Research Center PC
Farmington Hills, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Cardiology Asociates Research LLC
Tupelo, Mississippi, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States
Maimonides Medical Center-Brooklyn
Brooklyn, New York, United States
Buffalo General Medical Center/Roswell Park Cancer Institute
Buffalo, New York, United States
Stony Brook University Hospital and Medical Center
Stony Brook, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Presbyterian CVI Research
Charlotte, North Carolina, United States
CaroMont Heart
Gastonia, North Carolina, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Oklahoma Health and Sciences Center
Oaklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Drexel University/Hahnemann University Medical Center
Philadelphia, Pennsylvania, United States
University of PIttsburg Medical Center
Pittsburgh, Pennsylvania, United States
Miriam Hospital
Providence, Rhode Island, United States
Stern Cardiovascular Foundation/Baptist Hospital
Memphis, Tennessee, United States
Austin Heart
Austin, Texas, United States
University of Texas Medical Branch - Galveston
Galveston, Texas, United States
Texas Heart Institute
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Methodist Health Systems of San Antonio
San Antonio, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
UVA Health System Cardiology Research
Charlottesville, Virginia, United States
Centra Lynchburg General Hospital
Lynchburg, Virginia, United States
Aurora Health Care Metro, Inc/St. Lukes Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Quyyumi AA, Vasquez A, Kereiakes DJ, Klapholz M, Schaer GL, Abdel-Latif A, Frohwein S, Henry TD, Schatz RA, Dib N, Toma C, Davidson CJ, Barsness GW, Shavelle DM, Cohen M, Poole J, Moss T, Hyde P, Kanakaraj AM, Druker V, Chung A, Junge C, Preti RA, Smith RL, Mazzo DJ, Pecora A, Losordo DW. PreSERVE-AMI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Intracoronary Administration of Autologous CD34+ Cells in Patients With Left Ventricular Dysfunction Post STEMI. Circ Res. 2017 Jan 20;120(2):324-331. doi: 10.1161/CIRCRESAHA.115.308165. Epub 2016 Nov 7.
Other Identifiers
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002
Identifier Type: -
Identifier Source: org_study_id
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