search
Back to results

Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Transplantation to Treat Heart Diseases (CSHSBMMCTTHD)

Primary Purpose

Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypoxia-stressed BMSCs transplantation to cure MI
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of acute Myocardial Infarction(within one month);
  • Age under 65;
  • Infarction related wall motion abnormality on echocardiography;
  • Infarction related TIMI flow grades 3 on coronary angiography during cell injection;
  • Informed consent;

Exclusion Criteria:

  • Active infection, or hematopoietic malignancy;
  • Patients have tumor or other lethal diseases;
  • Informed refusal

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    BMSCs transplantation

    No BMSCs transplantation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Heart function

    Secondary Outcome Measures

    Full Information

    First Posted
    November 3, 2010
    Last Updated
    November 3, 2010
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01234181
    Brief Title
    Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Transplantation to Treat Heart Diseases
    Acronym
    CSHSBMMCTTHD
    Official Title
    Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Intracoronary Transplantation in Myocardial Infarction and Other Heart Diseases.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    December 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BMSCs transplantation
    Arm Type
    Experimental
    Arm Title
    No BMSCs transplantation
    Arm Type
    Sham Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Hypoxia-stressed BMSCs transplantation to cure MI
    Intervention Description
    Experimental group: intracoronary injection of 10^7 BMSCs Sham Comparator: inject the same volume saline
    Primary Outcome Measure Information:
    Title
    Heart function
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of acute Myocardial Infarction(within one month); Age under 65; Infarction related wall motion abnormality on echocardiography; Infarction related TIMI flow grades 3 on coronary angiography during cell injection; Informed consent; Exclusion Criteria: Active infection, or hematopoietic malignancy; Patients have tumor or other lethal diseases; Informed refusal
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jian'an Wang, M.D, Ph.D
    Organizational Affiliation
    2nd Affiliated Hospital, School of Medicine at Zhejiang University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18374759
    Citation
    Hu X, Yu SP, Fraser JL, Lu Z, Ogle ME, Wang JA, Wei L. Transplantation of hypoxia-preconditioned mesenchymal stem cells improves infarcted heart function via enhanced survival of implanted cells and angiogenesis. J Thorac Cardiovasc Surg. 2008 Apr;135(4):799-808. doi: 10.1016/j.jtcvs.2007.07.071.
    Results Reference
    background
    PubMed Identifier
    25755063
    Citation
    Hu X, Huang X, Yang Q, Wang L, Sun J, Zhan H, Lin J, Pu Z, Jiang J, Sun Y, Xiang M, Liu X, Xie X, Yu X, Chen Z, Tse HF, Zhang J, Wang J. Safety and efficacy of intracoronary hypoxia-preconditioned bone marrow mononuclear cell administration for acute myocardial infarction patients: The CHINA-AMI randomized controlled trial. Int J Cardiol. 2015 Apr 1;184:446-451. doi: 10.1016/j.ijcard.2015.02.084. Epub 2015 Feb 25.
    Results Reference
    derived

    Learn more about this trial

    Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Transplantation to Treat Heart Diseases

    We'll reach out to this number within 24 hrs