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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Death; Myocardial Reperfusion Injury; Left Ventricular Function Diastolic Dysfunction; Left Ventricular Function Systolic Dysfunction

Study type: Observational

Funder types: Other

Identifiers

NCT01307371

DIABETES-STEMI

Details and patient eligibility

About

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).

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

Diabetes

Description:

Patients with diabetes.

non-diabetes

Description:

Patients without diabetes.