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

Xijing Hospital110 enrolled

Overview

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).

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

110

Conditions

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Xijing Hospital

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

Number of patient death during the follow up period

Number of patient death during the follow up period as a measure of safety

Time frame: 4years

Secondary Outcomes

Left ventricular ejection fraction

Left ventricular ejection fraction as evaluated by echocardiography and SPECT

Time frame: 4 years

Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)

Time frame: 4 years

Infarct size as evaluated by Single-photon emission computed tomography (SPECT)

Time frame: 4 years

Number of target vessel revascularization

Number of target vessel revascularization during the follow up period

Time frame: 4 years

Angina class according to the canadian cardiovascular society (CCS) classification

Time frame: 4 years

Scores on the Seattle angina questionnaire

Time frame: 4 years

six-min walk distance (6MWD)

Quality of life as evaluated by 6-min walk distance

Time frame: 4 years

Data from ClinicalTrials.gov

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