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

February 12, 2015 updated by: Navy General Hospital, Beijing

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100048
        • Fu Cheng Lu 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months- 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months-1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Collaborators

General Hospital of Chinese Armed Police Forces
Chinese PLA General Hospital
First People's Hospital of Foshan

Investigators

  • Study Chair: Lian Ru Gao, MD, Cardiology Division of Navy General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

February 4, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (ESTIMATE)

February 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006AA02Z469

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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