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Intracoronary Human Wharton's Jelly- Derived Mesenchymal Stem Cells (WJ-MSCs) Transfer in Patients With Acute Myocardial Infarction (AMI) (WJ-MSC-AMI)

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ClinicalTrials.gov Identifier: NCT01291329
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : February 13, 2015
Sponsor:
Collaborators:
Chinese PLA General Hospital
General Hospital of Chinese Armed Police Forces
First People's Hospital of Foshan
Information provided by:
Navy General Hospital, Beijing

Tracking Information
First Submitted Date  ICMJE February 4, 2011
First Posted Date  ICMJE February 8, 2011
Last Update Posted Date February 13, 2015
Study Start Date  ICMJE February 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2015)
Quantify myocardium metabolic and perfusion measured by F-18-fluorodeoxyglucose (F-18-FDG) postremission tomography (PET) and 99 mTctetrofosmine single-photon (SPET), as well as global left ventricular ejection fraction measured by echocardiography. [ Time Frame: 4 months- 1 year ]
The primary endpoints were differences between the two treatments and from baseline to 4 months in quantitative myocardial metabolic and perfusion images, as measured by 18F-FDG positron emission tomography and 99 mTctetrofosmine single-photon imaging. Left ventricular ejection fraction is measured by 16-segment 2-D echocardiography.
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2011)
Quantify myocardium metabolic and perfusion measured by F-18-fluorodeoxyglucose (F-18-FDG) positronemission tomography (PET) and 99 mTctetrofosmine single-photon (SPET), as well as global left ventricular ejection fraction measured by echocardiography. [ Time Frame: 4 months- 1 year ]
The primary endpoints were differences between the two treatments and from baseline to 4 months in quantitative myocardial metabolic and perfusion images, as measured by 18F-FDG positron emission tomography and 99 mTctetrofosmine single-photon imaging. Left ventricular ejection fraction is measured by 16-segment 2-D echocardiography.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2011)
Secondary endpoints: safety will be determined by the assessment of major adverse coronary events (MACE). [ Time Frame: 4 months-1year ]
Safety will be determined by the assessment of major adverse coronary events (MACE) defined as cardiac death, peri-procedural myocardial infarction, or any repeat coronary intervention at 4 months-1year. Furthermore, safety is also determined by the occurrence of stent thrombosis, arrhythmias events. immune system disorders. The trial will be monitored by a Data and Safety Monitoring Board (DSMB) and the trial will be discontinued in case of safety concerns.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intracoronary Human Wharton's Jelly- Derived Mesenchymal Stem Cells (WJ-MSCs) Transfer in Patients With Acute Myocardial Infarction (AMI)
Official Title  ICMJE Phase 2 Study of Intracoronary Human Wharton's Jelly- Derived Mesenchymal Stem Cells (WJ-MSCs) Transfer in Patients With ST-segment Elevation Acute Myocardial Infarction (AMI)
Brief Summary The purpose of this study is to investigate the safety and efficacy of intracoronary human umbilical Wharton's jelly-derived mesenchymal stem cell (WJ-MSC) transfer in patients with ST-segment elevation acute myocardial infarction.
Detailed Description It has been demonstrated that MSCs have the potential to differentiate into cardiomyocytes both in vitro and in vivo. Several clinical trials have been performed using autologous bone marrow-derived MSCs, but the results of these trials have been unsatisfactory because of a low number of MSCs in older patients and in those with coronary heart disease. WJ-MSCs from the human umbilical cord matrix which are of epiblastic origin and contain both human embryonic stem cell (hESC) and human mesenchymal stem cell markers appear to have a number of important advantages: they do not raise ethical issues, are widely multipotent, are not tumorigenic, and are not immunogenetic. Because of a short population doubling time they can be rapidly scaled up in large numbers. We performed a double-blind, placebo-controlled, multicenter trial, randomly assigning 160 patients with acute ST-segment elevation myocardial infarction to receive an intracoronary infusion of WJ-MSCs or placebo medium into the infarct artery 4-7 days after successful reperfusion therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ST-Elevation Myocardial Infarction
Intervention  ICMJE Genetic: intracoronary human umbilical WJ-MSC transfer
intracoronary infusion of WJ-MSCs or placebo medium into the infarct artery 4-7 days after successful reperfusion therapy.
Study Arms  ICMJE Experimental: WJ-MSC
Wharton's jelly- Derived Mesenchymal Stem Cells Transfer
Intervention: Genetic: intracoronary human umbilical WJ-MSC transfer
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 7, 2011)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients at least 18 years of age;
  2. Patients with 1st acute ST-elevation myocardial infarction (AMI) who undergo successful primary percutaneous coronary intervention (PCI) thrombolysis in myocardial infarction (TIMI) flow grade 3, but have a substantial residual left ventricular regional wall-motion abnormality measured by 2-D echocardiography.
  3. No contraindications to undergoing cell-therapy procedure within 1 weeks after AMI and PCI.
  4. Hemodynamic stability-defined as no requirement for intra-aortic balloon pump or for inotropic or blood-pressure supporting medications.
  5. Consent to protocol and agree to comply with all follow-up visits and studies.

Exclusion Criteria:

  1. Presence of cardiogenic shock ( defined as systolic blood pressure < 80 mmHg requiring intravenous pressors or intra-aortic balloon counterpulsation);
  2. Major bleeding requiring blood transfusion after acute reperfusion treatment;
  3. A history of leucopenia;
  4. Thrombocytopenia;
  5. Hepatic or renal dysfunction;
  6. Evidence for malignant diseases;
  7. Unwillingness to participate;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01291329
Other Study ID Numbers  ICMJE 2006AA02Z469
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Lian Ru Gao, Cardiology Division of Navy General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Navy General Hospital, Beijing
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Chinese PLA General Hospital
  • General Hospital of Chinese Armed Police Forces
  • First People's Hospital of Foshan
Investigators  ICMJE
Study Chair: Lian Ru Gao, MD Cardiology Division of Navy General Hospital
PRS Account Navy General Hospital, Beijing
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP