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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Navy General Hospital, Beijing

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
General Hospital of Chinese Armed Police Forces
Chinese PLA General Hospital
First People's Hospital of Foshan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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