Cell Therapy in Diabetic Patients With ST-Segment Elevation Myocardial Infarction(STEMI)

February 28, 2011 updated by: Xijing Hospital

Effects and Mechanism of Autologous Bone Marrow Mononuclear Cells (BMMNC)Transplantation in Diabetic Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Who Have Undergone Percutaneous Coronary Intervention (PCI)

The purpose of this study is to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone percutaneous coronary intervention (PCI).

Study Overview

Status

Unknown

Conditions

Detailed Description

Stem cells are capable of the important properties of self-renewal and differentiation plasticity. Human autologous bone marrow mononuclear cells (BMMNC) contain CD34+ haematopoietic and CD34- mesenchymal stem cells. Both of these cell types may contribute to heart muscle repair in acute myocardial infarction (AMI). In recent years, a variety of clinical trials have explored the hypothesis that BMMNC transplantation may enhance the recovery of left ventricular function after AMI. The use of BMMNC is clinically justified and ethically unquestionable because no severe side effects have been reported and immunosuppressive therapy is unnecessary. More over, our previous work showed that patients without diabetes may benefit more from BMMNC transplantation. Thus, the aim of the present study was to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone PCI.

Study Type

Observational

Enrollment (Anticipated)

110

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
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:

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

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of STEMI with the culprit lesion of left anterior decending (LAD)coronary artery were enrolled in this study.

Description

Inclusion Criteria:

  • age between 25 and 60 years old
  • STEMI according to the WHO definition
  • PCI <12 hours from the onset of symptoms
  • LAD disease with an open infarct related artery

Exclusion Criteria:

  • previous myocardial infarction (MI)
  • cardiomyopathy
  • atrial fibrillation or flutter
  • previous heart surgery
  • severe valvular heart disease
  • disease of the hematopoietic system
  • NYHA functional class IV heart failure at baseline
  • severe renal, lung and liver disease
  • cancer
  • intra-cardiac thrombus
  • bone marrow disease

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Diabetes
Patients with diabetes.
non-diabetes
Patients without diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patient death during the follow up period
Time Frame: 4years
Number of patient death during the follow up period as a measure of safety
4years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction
Time Frame: 4 years
Left ventricular ejection fraction as evaluated by echocardiography and SPECT
4 years
Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)
Time Frame: 4 years
4 years
Infarct size as evaluated by Single-photon emission computed tomography (SPECT)
Time Frame: 4 years
4 years
Number of target vessel revascularization
Time Frame: 4 years
Number of target vessel revascularization during the follow up period
4 years
Angina class according to the canadian cardiovascular society (CCS) classification
Time Frame: 4 years
4 years
Scores on the Seattle angina questionnaire
Time Frame: 4 years
4 years
six-min walk distance (6MWD)
Time Frame: 4 years
Quality of life as evaluated by 6-min walk distance
4 years

Collaborators and Investigators

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

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Feng Cao, MD, PhD, Air Force Military Medical University, China

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

March 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (Estimate)

March 2, 2011

Study Record Updates

Last Update Posted (Estimate)

March 2, 2011

Last Update Submitted That Met QC Criteria

February 28, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIABETES-STEMI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Death

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe