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Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)

Primary Purpose

Acute Myocardial Infarction, Myocardial Infarction, Ischemic Cardiomyopathy

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
umbilical cord mesenchymal stem cells
Sponsored by
South China Research Center for Stem Cell and Regenerative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery;
  • LVEF (left ventricular ejection fraction): 25-45%;
  • Age between 18 and 70, borh gender;
  • Women of childbearing age agreed to take contraceptive measures during the whole study period;
  • No psychiatric illnesses and speaking dysfunction;
  • Informed consent.

Exclusion Criteria:

  • Structural heart disease, Valvular heart disease, Refractory hypertension(Unstable blood pressure control), LVEF<24%;
  • Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamic-oxaloacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value;
  • Patients suffered from severe arrhythmia;
  • Patients suffered from stent thrombosis;
  • Patients receiving immunosuppressive therapy;
  • Patients have tumor or other lethal diseases (expectation of life<6 months);
  • Women who plan to be pregnant or are pregnant or nursing;
  • Allergic constitution(Allergic to more than two kinds of drugs,food, or pollen);
  • Other clinical trial participants within 3 months;
  • Investigators judge other conditions not suitable for inclusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    UCMSCs

    controls

    Arm Description

    Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs)

    Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion

    Outcomes

    Primary Outcome Measures

    Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.
    Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).

    Secondary Outcome Measures

    Pump failure Killip classification
    New York Heart Association(NYHA) classification
    Occurrence of major adverse event

    Full Information

    First Posted
    January 21, 2016
    Last Updated
    January 24, 2016
    Sponsor
    South China Research Center for Stem Cell and Regenerative Medicine
    Collaborators
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02666391
    Brief Title
    Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    South China Research Center for Stem Cell and Regenerative Medicine
    Collaborators
    Sun Yat-sen University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myocardial Infarction, Myocardial Infarction, Ischemic Cardiomyopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    UCMSCs
    Arm Type
    Experimental
    Arm Description
    Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs)
    Arm Title
    controls
    Arm Type
    No Intervention
    Arm Description
    Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion
    Intervention Type
    Biological
    Intervention Name(s)
    umbilical cord mesenchymal stem cells
    Primary Outcome Measure Information:
    Title
    Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.
    Time Frame
    1 week, 6 month, 12 month,18 month
    Title
    Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).
    Time Frame
    1 week, 18 month
    Secondary Outcome Measure Information:
    Title
    Pump failure Killip classification
    Time Frame
    baseline, 1 week, 1 month, 6 month, 12 month,18 month
    Title
    New York Heart Association(NYHA) classification
    Time Frame
    1 week, 1 month, 6 month, 12 month,18 month
    Title
    Occurrence of major adverse event
    Time Frame
    3 day, 1 week, 1 month, 6 month, 12 month,18 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery; LVEF (left ventricular ejection fraction): 25-45%; Age between 18 and 70, borh gender; Women of childbearing age agreed to take contraceptive measures during the whole study period; No psychiatric illnesses and speaking dysfunction; Informed consent. Exclusion Criteria: Structural heart disease, Valvular heart disease, Refractory hypertension(Unstable blood pressure control), LVEF<24%; Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamic-oxaloacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value; Patients suffered from severe arrhythmia; Patients suffered from stent thrombosis; Patients receiving immunosuppressive therapy; Patients have tumor or other lethal diseases (expectation of life<6 months); Women who plan to be pregnant or are pregnant or nursing; Allergic constitution(Allergic to more than two kinds of drugs,food, or pollen); Other clinical trial participants within 3 months; Investigators judge other conditions not suitable for inclusion.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xuetao Pei, M.D., Ph.D
    Phone
    8610-68164807
    Email
    AMMS0906@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junnian Zhou, Ph.D
    Phone
    8620-89199011
    Email
    zhoujunnian@scrm.org.cn

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23651816
    Citation
    Gao LR, Pei XT, Ding QA, Chen Y, Zhang NK, Chen HY, Wang ZG, Wang YF, Zhu ZM, Li TC, Liu HL, Tong ZC, Yang Y, Nan X, Guo F, Shen JL, Shen YH, Zhang JJ, Fei YX, Xu HT, Wang LH, Tian HT, Liu DQ, Yang Y. A critical challenge: dosage-related efficacy and acute complication intracoronary injection of autologous bone marrow mesenchymal stem cells in acute myocardial infarction. Int J Cardiol. 2013 Oct 9;168(4):3191-9. doi: 10.1016/j.ijcard.2013.04.112. Epub 2013 May 4.
    Results Reference
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    Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)

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