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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

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.

Condition or disease Intervention/treatment Phase
ST-Elevation Myocardial Infarction Genetic: intracoronary human umbilical WJ-MSC transfer Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : February 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: WJ-MSC
Wharton's jelly- Derived Mesenchymal Stem Cells Transfer
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291329


Locations
China
Fu Cheng Lu 6
Beijing, China, 100048
Sponsors and Collaborators
Navy General Hospital, Beijing
Chinese PLA General Hospital
General Hospital of Chinese Armed Police Forces
First People's Hospital of Foshan
Investigators
Study Chair: Lian Ru Gao, MD Cardiology Division of Navy General Hospital

Publications of Results:
1.Monya Baker. How to fix a broken heart? Nature. 2009; 460:18-19. 2.Psaltis PJ, Zannettino A, Worthley SG. Mesenchymal stromal cells potential for cardiovascular repair. Stem cells.2008; 10:1634. 3.Deryl L, Mark LT, Weiss, et al. Concise review : wharton's jelly-derived cells are a primitive stromal cell population. Stem Cells. 2008 ; 26 :591-599. 4.Nekanti U, Rao VB, Bahirvani AG, Ta M, et al. Long-term Expansion and Pluripotent Marker Array Analysis of Wharton's Jelly-Derived Mesenchymal Stem Cells. Stem Cells and Dev. 2010; 19:117-130. 5.Chen MY, Lie PC, Li ZL. Endothelial differentiation of Wharton's jelly-derived mesenchymal stem cells in comparison with bone marrow-derived mesenchymal stem cells. Exp Hematol. 2009;37(5):629-40.. 6.Wu KH, Mo XM, Zhou, B. et al. Cardiac potential of stem cells from whole human umbilical cord tissue. Journal of Cellular Biochemistry. 2009; 107:926-932.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lian Ru Gao, Cardiology Division of Navy General Hospital
ClinicalTrials.gov Identifier: NCT01291329     History of Changes
Other Study ID Numbers: 2006AA02Z469
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015

Keywords provided by Navy General Hospital, Beijing:
stem cell
acute ST-Elevation Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases