NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction

NCT01495364 | Completed Phase 2 DMC

• 1 other identifier: 002
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 58

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.

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

STEMI

Outcome Measures

Primary Outcomes (1)

• To determine safety and efficacy of intracoronary infusion of NBS10.

  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.

  primary outcome measured at 6 months

Study Arms (2)

NBS10

EXPERIMENTAL

active treatment - CD34+ cells

Biological: NBS10

placebo

PLACEBO COMPARATOR

matching placebo

Other: placebo

Interventions

NBS10 BIOLOGICAL

dosage = 10 or more million CD34+ cells via intracoronary infusion

Also known as: AMR-001

NBS10

placebo OTHER

matching placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Wall motion abnormality associated with the target lesion
• NYHA heart failure class I, II or III.
• Study entry LVEF \<48% determined by CMR no sooner than 96 hours from stent placement.
• Able to provide informed written consent and willing to participate in all required study follow-up assessments.
• Subjects must have an INR ≤ 2.0 within 2 days of the bone marrow collection.
• 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.
• Expected survival of at least one year.
• Females of child bearing potential agree to use birth control (barrier method accepted) for one month post bone marrow harvest.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lisata Therapeutics, Inc.: lead

Study Sites (58)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Heart Center Research, LLC (Huntsville Hospital)

Huntsville, Alabama, 35801, United States

Location

Mercy Gilbert Medical Group

Gilbert, Arizona, 85297, United States

Location

Mayo Clinic - Arizona

Phoenix, Arizona, 85054, United States

Location

Scripps-La Jolla, CA

La Jolla, California, 92037, United States

Location

Keck School of Medicine - University of Southern California

Los Angeles, California, 90033, United States

Location

St.Johns Regional Hospital and Medical Center

Oxnard, California, 93030, United States

Location

Standford University School of Medicine

Stanford, California, 94305, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida-Gainesville

Gainesville, Florida, 32610, United States

Location

Orlando Health Medical Center

Orlando, Florida, 32806, United States

Location

Pepin Heart Institute - Florida Hospital -Tampa

Tampa, Florida, 33513, United States

Location

Emory University Medical Center

Atlanta, Georgia, 30322, United States

Location

St. Joseph's Research Institute

Atlanta, Georgia, 30342, United States

Location

Northeast Georgia Heart Center

Gainesville, Georgia, 30501, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Advocate Health and Hospital Corp.

Downer's Grove, Illinois, 60515, United States

Location

Advocate Health and Hospital Corp.

Elmhurst, Illinois, 60126, United States

Location

St. Vincent's Medical Group/St. Vincent's Heart Center of Indiana

Indianapolis, Indiana, 46260, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky, Gill Heart Institute

Lexington, Kentucky, 40536, United States

Location

Louisville Cardiology Medical Group

Louisville, Kentucky, 40207, United States

Location

University of Maryland Med Center, Baltimore

Baltimore, Maryland, 21201, United States

Location

Metrowest Medical Center

Framingham, Massachusetts, 01702, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Detroit Clinical Research Center PC

Farmington Hills, Michigan, 48334, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cardiology Asociates Research LLC

Tupelo, Mississippi, 38801, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07103, United States

Location

Maimonides Medical Center-Brooklyn

Brooklyn, New York, 11219, United States

Location

Buffalo General Medical Center/Roswell Park Cancer Institute

Buffalo, New York, 14203, United States

Location

Stony Brook University Hospital and Medical Center

Stony Brook, New York, 11794-8167, United States

Location

Westchester Medical Center

Valhalla, New York, 10532, United States

Location

Presbyterian CVI Research

Charlotte, North Carolina, 28024, United States

Location

CaroMont Heart

Gastonia, North Carolina, 28054, United States

Location

The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Health and Sciences Center

Oaklahoma City, Oklahoma, 73104, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Drexel University/Hahnemann University Medical Center

Philadelphia, Pennsylvania, 19102, United States

Location

University of PIttsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Miriam Hospital

Providence, Rhode Island, 02904, United States

Location

Stern Cardiovascular Foundation/Baptist Hospital

Memphis, Tennessee, 38138, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

University of Texas Medical Branch - Galveston

Galveston, Texas, 77555, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Methodist Health Systems of San Antonio

San Antonio, Texas, 78229, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

UVA Health System Cardiology Research

Charlottesville, Virginia, 22908, United States

Location

Centra Lynchburg General Hospital

Lynchburg, Virginia, 25401, United States

Location

Aurora Health Care Metro, Inc/St. Lukes Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (1)

• 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.

  PMID: 27821724 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Tom Moss, MD

  Lisata Therapeutics, Inc.

  STUDY DIRECTOR

• Arshed Quyyumi, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 20, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: April 1, 2016
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

US (58)