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Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BMC therapy within 24 hours
BMC therapy within 3-7 days
BMC therapy within 7-30 days
PCI only
Sponsored by
The First Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring cell therapy, BMC, timing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a history of first acute ST-elevation myocardial infarction
  • treatment with successful PCI two to twelve hours after symptom onset
  • LVEF less than 50% on angiography immediately after emergency PCI or rescue PCI

Exclusion Criteria:

  • previous Q-wave myocardial infarction
  • cardiogenic shock
  • severe coexisting conditions such as acute and chronic heart failure, malignant
  • arrhythmia, renal failure and severe bleeding that interfered with the ability of the
  • patient to comply with the protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    BMC therapy within 24 hours

    BMC therapy within 3-7 days

    BMC therapy within 7-30 days

    PCI only

    Arm Description

    Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 24 hours after successful primary PCI.

    Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 3-7days after successful primary PCI.

    Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 7-30days after successful primary PCI.

    Patients with acute myocardial infarction who were performed successful primary PCI.

    Outcomes

    Primary Outcome Measures

    Change of left ventricular eject factor (LVEF) from the baseline

    Secondary Outcome Measures

    Change of left ventricular end-diastolic volume (LVESV) from the baseline
    Change of left ventricular end-systolic volume (LVEDV) from the baseline
    Change of myocardial perfusion from the baseline

    Full Information

    First Posted
    April 15, 2015
    Last Updated
    April 23, 2015
    Sponsor
    The First Affiliated Hospital of Dalian Medical University
    Collaborators
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02425358
    Brief Title
    Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction
    Official Title
    Timing for Intracoronary Administration of Bone Marrow Mononuclear Cells After Acute ST-elevated Myocardial Infarction: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2005 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Affiliated Hospital of Dalian Medical University
    Collaborators
    Fudan University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary intervention (PCI); however, the optimal timing is unknown. The present study assessed the therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).
    Detailed Description
    On the basis of experimental studies that bone marrow mononuclear cells (BMCs) transfer in the injured tissue can promote regional myocardial perfusion and improved cardiac function, several clinical trials have shown that intracoronary bone marrow mononuclear cell (BMC) transplantation in acute myocardial infarction (AMI) patients several days after myocardial reperfusion is safe and may enhance the improvement of left ventricular ejection fraction (LVEF). The timing of BMC administration, baseline LVEF, dosage of BMC and other factors has been linked to improvement in LVEF after BMC transplantation. In our previous work, we gave BMCs within 24 hours after emergency percutaneous coronary intervention (PCI) and found that it was safe and effective . In addition, there are another report about longer time from symptom onset to BMC infusion (2-4 weeks), which also appeared effective . The timing of intracoronary stem cell administration may have a critical effect on cell engraftment and may be responsible for the various biological and functional responses to therapy. However, few studies have directly addressed the optimal timing of cell injections. Therefore, in this prospective randomized study, BMCs were given at different times (within 24 hours, 3 to 7 days, or 7 to 30 days after reperfusion) to investigate whether the timing of therapy affects the therapeutic response of AMI patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction
    Keywords
    cell therapy, BMC, timing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BMC therapy within 24 hours
    Arm Type
    Experimental
    Arm Description
    Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 24 hours after successful primary PCI.
    Arm Title
    BMC therapy within 3-7 days
    Arm Type
    Experimental
    Arm Description
    Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 3-7days after successful primary PCI.
    Arm Title
    BMC therapy within 7-30 days
    Arm Type
    Experimental
    Arm Description
    Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 7-30days after successful primary PCI.
    Arm Title
    PCI only
    Arm Type
    Active Comparator
    Arm Description
    Patients with acute myocardial infarction who were performed successful primary PCI.
    Intervention Type
    Other
    Intervention Name(s)
    BMC therapy within 24 hours
    Intervention Description
    The BMCs were isolated by Ficoll density gradient centrifugation on Lymphocyte Separation Medium. BMCs were infused into IRA at the site of the previous occlusion. This was accomplished with the use of a microtubular. After positioning of the microtubular into the distal segment vessel of the stent position in the infarct-related artery, 15 milliliter of the whole cell suspension was slowly administered via microtubular. The usual time should be over 10min to prevent back-flow and to prolong cellular contact time for cellular migration into the tissue. Patients in BMC therapy group within 24 hours remained in the cath-lab until the entire procedure, including primary PCI and intracoronary BMC infusion, was completed.
    Intervention Type
    Other
    Intervention Name(s)
    BMC therapy within 3-7 days
    Intervention Description
    Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.
    Intervention Type
    Other
    Intervention Name(s)
    BMC therapy within 7-30 days
    Intervention Description
    Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.
    Intervention Type
    Other
    Intervention Name(s)
    PCI only
    Intervention Description
    The saline was intracoronary infusion with the use of microtubular.
    Primary Outcome Measure Information:
    Title
    Change of left ventricular eject factor (LVEF) from the baseline
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Change of left ventricular end-diastolic volume (LVESV) from the baseline
    Time Frame
    12 months
    Title
    Change of left ventricular end-systolic volume (LVEDV) from the baseline
    Time Frame
    12 months
    Title
    Change of myocardial perfusion from the baseline
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: a history of first acute ST-elevation myocardial infarction treatment with successful PCI two to twelve hours after symptom onset LVEF less than 50% on angiography immediately after emergency PCI or rescue PCI Exclusion Criteria: previous Q-wave myocardial infarction cardiogenic shock severe coexisting conditions such as acute and chronic heart failure, malignant arrhythmia, renal failure and severe bleeding that interfered with the ability of the patient to comply with the protocol

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19420003
    Citation
    Yao K, Huang R, Sun A, Qian J, Liu X, Ge L, Zhang Y, Zhang S, Niu Y, Wang Q, Zou Y, Ge J. Repeated autologous bone marrow mononuclear cell therapy in patients with large myocardial infarction. Eur J Heart Fail. 2009 Jul;11(7):691-8. doi: 10.1093/eurjhf/hfp062. Epub 2009 May 6.
    Results Reference
    background
    PubMed Identifier
    18381377
    Citation
    Yao K, Huang R, Qian J, Cui J, Ge L, Li Y, Zhang F, Shi H, Huang D, Zhang S, Sun A, Zou Y, Ge J. Administration of intracoronary bone marrow mononuclear cells on chronic myocardial infarction improves diastolic function. Heart. 2008 Sep;94(9):1147-53. doi: 10.1136/hrt.2007.137919. Epub 2008 Apr 1.
    Results Reference
    background
    PubMed Identifier
    26021558
    Citation
    Huang R, Yao K, Sun A, Qian J, Ge L, Zhang Y, Niu Y, Wang K, Zou Y, Ge J. Timing for intracoronary administration of bone marrow mononuclear cells after acute ST-elevation myocardial infarction: a pilot study. Stem Cell Res Ther. 2015 May 29;6(1):112. doi: 10.1186/s13287-015-0102-5.
    Results Reference
    derived

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    Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction

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