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

NCT ID: NCT01307371

Last Updated: 2011-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Left Ventricular Function Systolic Dysfunction Left Ventricular Function Diastolic Dysfunction Death Myocardial Reperfusion Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes

Patients with diabetes.

No interventions assigned to this group

non-diabetes

Patients without diabetes.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xijing Hospital, Fourth Military Medical University

Principal Investigators

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Feng Cao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Dongdong Sun, MD, PhD

Role: primary

86 29 84775183

Other Identifiers

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DIABETES-STEMI

Identifier Type: -

Identifier Source: org_study_id

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