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

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

• Registration Number: NCT01307371
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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 Timeline

• Study Start: 2007-03
• Primary Completion: 2008-03
• Status Verified: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-28
• Last Update Submitted: 2011-02-28
• Study First Posted: 2011-03-02
• Last Update Posted: 2011-03-02
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patient death during the follow up period	4years	Number of patient death during the follow up period as a measure of safety

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China