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Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease (TPAABPIHD)

Primary Purpose

Myocardial Infarction, Acute Myocardial Infarction, Ischemic Cardiomyopathy

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BMMSCs
Sponsored by
Academy Military Medical Science, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

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

Inclusion Criteria:

  • Age under 75;
  • Clinical diagnosis of acute Myocardial Infarction, chronic Myocardial Infarction and Ischemic Cardiomyopathy
  • NYHA (New York Heart Association) grade: III-IV, LVEF (left ventricular ejection fraction): 25-50%;
  • No infection diseases including HBV (hepatitis B virus), HCV (hepatitis C virus ), syphilis and AIDS;
  • No psychiatric illnesses and speaking dysfunction;
  • Informed consent.

Exclusion Criteria:

  • More than 75 years old;
  • LVEF<24%;
  • Unstable hemodynamics, shock;
  • Severe infection;
  • Patients have tumor or other lethal diseases (expectation of life<6 months);
  • Radiation patients;
  • hematopoietic malignancy including Haemophiliacs;
  • Anemia (Hb<100g/L);
  • The other clinical trial participants within one month;
  • Abnormal increasing of the blood biochemical indicators that is not explained by the conditions;
  • Informed refusal.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Arm Label

    pre-conditioned BMMSCs

    BMMSCs

    Controls

    Arm Description

    autologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction.

    autologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition.

    standard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion.

    Outcomes

    Primary Outcome Measures

    LVEF (left ventricular ejection fraction)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2015
    Last Updated
    July 20, 2015
    Sponsor
    Academy Military Medical Science, China
    Collaborators
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02504437
    Brief Title
    Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease
    Acronym
    TPAABPIHD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Academy Military Medical Science, China
    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 efficacy of the preconditioned autologous bone marrow 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
    Myocardial Infarction, Acute Myocardial Infarction, Ischemic Cardiomyopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pre-conditioned BMMSCs
    Arm Type
    Experimental
    Arm Description
    autologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction.
    Arm Title
    BMMSCs
    Arm Type
    Active Comparator
    Arm Description
    autologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition.
    Arm Title
    Controls
    Arm Type
    Sham Comparator
    Arm Description
    standard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion.
    Intervention Type
    Biological
    Intervention Name(s)
    BMMSCs
    Primary Outcome Measure Information:
    Title
    LVEF (left ventricular ejection fraction)
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age under 75; Clinical diagnosis of acute Myocardial Infarction, chronic Myocardial Infarction and Ischemic Cardiomyopathy NYHA (New York Heart Association) grade: III-IV, LVEF (left ventricular ejection fraction): 25-50%; No infection diseases including HBV (hepatitis B virus), HCV (hepatitis C virus ), syphilis and AIDS; No psychiatric illnesses and speaking dysfunction; Informed consent. Exclusion Criteria: More than 75 years old; LVEF<24%; Unstable hemodynamics, shock; Severe infection; Patients have tumor or other lethal diseases (expectation of life<6 months); Radiation patients; hematopoietic malignancy including Haemophiliacs; Anemia (Hb<100g/L); The other clinical trial participants within one month; Abnormal increasing of the blood biochemical indicators that is not explained by the conditions; Informed refusal.
    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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    Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease

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