NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction
- Conditions
- ST Segment Elevation Myocardial Infarction
- Interventions
- Other: placeboBiological: NBS10
- Registration Number
- NCT01495364
- Lead Sponsor
- Lisata Therapeutics, Inc.
- Brief Summary
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). This will be assessed by evaluating and comparing the autologous stem cell treatment group to the control group in terms of the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE), by the change in myocardial perfusion (RTSS) measured quantitatively by gated single photon emission computed tomography myocardial perfusion imaging (gated SPECT MPI), and other secondary endpoints such as LVEF measured by cardiac MRI in addition to other endpoints.
- Detailed Description
Efficacy endpoint is at 6 months. Clinical endpoints and safety will be measured through 36 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
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Age 18 years or older.
-
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.
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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.
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Wall motion abnormality associated with the target lesion
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NYHA heart failure class I, II or III.
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Study entry LVEF <48% determined by CMR no sooner than 96 hours from stent placement.
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Able to provide informed written consent and willing to participate in all required study follow-up assessments.
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Subjects must have an INR ≤ 2.0 within 2 days of the bone marrow collection.
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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.
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Expected survival of at least one year.
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Females of child bearing potential agree to use birth control (barrier method accepted) for one month post bone marrow harvest.
EXCLUSION CRITERIA
- 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.
- 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.
- Subjects unable to receive antiplatelet agents (e.g. aspirin, clopidogrel, ticlopidine, prasugrel, etc).
- Subjects receiving warfarin who have an INR >2 or with major bleeding requiring active transfusion support.
- 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.)
- Subjects with severe cardiac valvular disease expected to undergo surgery within 1 year.
- Subjects with known severe immunodeficiency states (AIDS).
- Cirrhosis requiring active medical management.
- Malignancy requiring active treatment (except basal cell skin cancer).
- Subjects with documented active alcohol and /or other substance abuse.
- Females of child bearing potential unless a pregnancy test is negative within 7 days of the mini-bone marrow harvest.
- Re-occlusion of the IRA prior to the infusion procedure.
- 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).
- Participation in an ongoing investigational trial.
- Active or suspected bacterial infection requiring systemic intravenous antibiotics.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo matching placebo NBS10 NBS10 active treatment - CD34+ cells
- Primary Outcome Measures
Name Time Method To determine safety and efficacy of intracoronary infusion of NBS10. primary outcome measured at 6 months The primary endpoint includes the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE) and the assessment of myocardial perfusion measured by quantitative gated SPECT MPI specifically looking at resting total severity score.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (57)
St. Joseph's Research Institute
🇺🇸Atlanta, Georgia, United States
University of Maryland Med Center, Baltimore
🇺🇸Baltimore, Maryland, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Methodist Health Systems of San Antonio
🇺🇸San Antonio, Texas, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
St. Vincent's Medical Group/St. Vincent's Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Detroit Medical Center
🇺🇸Detroit, Michigan, United States
University of PIttsburg Medical Center
🇺🇸Pittsburg, Pennsylvania, United States
Scripps-La Jolla, CA
🇺🇸La Jolla, California, United States
Heart Center Research, LLC (Huntsville Hospital)
🇺🇸Huntsville, Alabama, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Mayo Clinic - Arizona
🇺🇸Phoenix, Arizona, United States
St.Johns Regional Hospital and Medical Center
🇺🇸Oxnard, California, United States
Keck School of Medicine - University of Southern California
🇺🇸Los Angeles, California, United States
Orlando Health Medical Center
🇺🇸Orlando, Florida, United States
Northeast Georgia Heart Center
🇺🇸Gainesville, Georgia, United States
Standford University School of Medicine
🇺🇸Stanford, California, United States
Advocate Health and Hospital Corp.
🇺🇸Elmhurst, Illinois, United States
University of Florida-Gainesville
🇺🇸Gainesville, Florida, United States
Detroit Clinical Research Center PC
🇺🇸Farmington Hills, Michigan, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Kentucky, Gill Heart Institute
🇺🇸Lexington, Kentucky, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
UVA Health System Cardiology Research
🇺🇸Charlottesville, Virginia, United States
Metrowest Medical Center
🇺🇸Framingham, Massachusetts, United States
Stony Brook University Hospital and Medical Center
🇺🇸Stony Brook, New York, United States
Henry Ford Health Systems
🇺🇸Detroit, Michigan, United States
Cardiology Asociates Research LLC
🇺🇸Tupelo, Mississippi, United States
CaroMont Heart
🇺🇸Gastonia, North Carolina, United States
Drexel University/Hahnemann University Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Buffalo General Medical Center/Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
University of Texas Medical Branch - Galveston
🇺🇸Galveston, Texas, United States
Centra Lynchburg General Hospital
🇺🇸Lynchburg, Virginia, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
University of Oklahoma Health and Sciences Center
🇺🇸Oaklahoma City, Oklahoma, United States
Austin Heart
🇺🇸Austin, Texas, United States
Stern Cardiovascular Foundation/Baptist Hospital
🇺🇸Memphis, Tennessee, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Pepin Heart Institute - Florida Hospital -Tampa
🇺🇸Tampa, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Aurora Health Care Metro, Inc/St. Lukes Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Maimonides Medical Center-Brooklyn
🇺🇸Brooklyn, New York, United States
Emory University Medical Center
🇺🇸Atlanta, Georgia, United States
Presbyterian CVI Research
🇺🇸Charlotte, North Carolina, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Louisville Cardiology Medical Group
🇺🇸Louisville, Kentucky, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mercy Gilbert Medical Group
🇺🇸Gilbert, Arizona, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States