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ST Segment Elevation Myocardial InfarctionPhase 2PreSERVE-AMINCT01495364

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

A Phase 2 study testing NBS10 in people with ST Segment Elevation Myocardial Infarction, run by Lisata Therapeutics, Inc. at 58 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NBS10
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
195 participants
Where
58 sitesUnited States
Study dates
Dec 2011to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University Medical Center

    Atlanta, Georgia, 30322

  • St. Joseph's Research Institute

    Atlanta, Georgia, 30342

  • Austin Heart

    Austin, Texas, 78756

  • University of Maryland Med Center, Baltimore

    Baltimore, Maryland, 21201

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Maimonides Medical Center-Brooklyn

    Brooklyn, New York, 11219

  • Buffalo General Medical Center/Roswell Park Cancer Institute

    Buffalo, New York, 14203

  • Presbyterian CVI Research

    Charlotte, North Carolina, 28024

  • UVA Health System Cardiology Research

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

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

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Detroit Medical Center

    Detroit, Michigan, 48201

  • Henry Ford Health Systems

    Detroit, Michigan, 48202

  • Advocate Health and Hospital Corp.

    Downer's Grove, Illinois, 60515

  • Advocate Health and Hospital Corp.

    Elmhurst, Illinois, 60126

  • Detroit Clinical Research Center PC

    Farmington Hills, Michigan, 48334

  • Metrowest Medical Center

    Framingham, Massachusetts, 01702

  • University of Florida-Gainesville

    Gainesville, Florida, 32610

  • Northeast Georgia Heart Center

    Gainesville, Georgia, 30501

  • University of Texas Medical Branch - Galveston

    Galveston, Texas, 77555

  • CaroMont Heart

    Gastonia, North Carolina, 28054

  • Mercy Gilbert Medical Group

    Gilbert, Arizona, 85297

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Texas Heart Institute

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Heart Center Research, LLC (Huntsville Hospital)

    Huntsville, Alabama, 35801

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

    Indianapolis, Indiana, 46260

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Scripps-La Jolla, CA

    La Jolla, California, 92037

  • University of Kentucky, Gill Heart Institute

    Lexington, Kentucky, 40536

  • Keck School of Medicine - University of Southern California

    Los Angeles, California, 90033

  • Louisville Cardiology Medical Group

    Louisville, Kentucky, 40207

  • Centra Lynchburg General Hospital

    Lynchburg, Virginia, 25401

  • Stern Cardiovascular Foundation/Baptist Hospital

    Memphis, Tennessee, 38138

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

    Milwaukee, Wisconsin, 53233

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • University of Medicine and Dentistry of New Jersey

    Newark, New Jersey, 07103

  • University of Oklahoma Health and Sciences Center

    Oaklahoma City, Oklahoma, 73104

  • Orlando Health Medical Center

    Orlando, Florida, 32806

  • St.Johns Regional Hospital and Medical Center

    Oxnard, California, 93030

  • Drexel University/Hahnemann University Medical Center

    Philadelphia, Pennsylvania, 19102

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

  • University of PIttsburg Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Miriam Hospital

    Providence, Rhode Island, 02904

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • Methodist Health Systems of San Antonio

    San Antonio, Texas, 78229

  • Standford University School of Medicine

    Stanford, California, 94305

  • Stony Brook University Hospital and Medical Center

    Stony Brook, New York, 11794-8167

  • Pepin Heart Institute - Florida Hospital -Tampa

    Tampa, Florida, 33513

  • Cardiology Asociates Research LLC

    Tupelo, Mississippi, 38801

  • Westchester Medical Center

    Valhalla, New York, 10532

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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.

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.

Read the detailed description

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

Being tested
NBS10, placebo
Keywords
STEMI
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBS10Biological

    Also called AMR-001

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

  • placeboOther

    matching placebo

Study groups in NCT01495364
Study groupRoleWhat they receive
NBS10Experimentalactive treatment - CD34+ cells
Receives: Biological: NBS10
placeboPlacebo comparatormatching placebo
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: primary outcome measured at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionJun 2014
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01495364
Sponsor's protocol ID
002
Acronym
PreSERVE-AMI
Status last verified
Apr 2016
First submitted
9 Dec 2011
Last updated
28 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27821724

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NBS10 in people with ST Segment Elevation Myocardial Infarction, run by Lisata Therapeutics, Inc. at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine safety and efficacy of intracoronary infusion of NBS10. (time frame: primary outcome measured at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01495364, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.

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