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

Death Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01307371
• Other study ID #: DIABETES-STEMI
• Status: Recruiting
• Phase: Phase 1
• First received: February 24, 2011
• Last updated: February 28, 2011
• Start date: March 2007
• Est. completion date: December 2011

Study information

• Verified date: February 2011
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2011
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient death during the follow up period	Number of patient death during the follow up period as a measure of safety	4years	Yes
Secondary	Left ventricular ejection fraction	Left ventricular ejection fraction as evaluated by echocardiography and SPECT	4 years	No
Secondary	Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)		4 years	No
Secondary	Infarct size as evaluated by Single-photon emission computed tomography (SPECT)		4 years	No
Secondary	Number of target vessel revascularization	Number of target vessel revascularization during the follow up period	4 years	No
Secondary	Angina class according to the canadian cardiovascular society (CCS) classification		4 years	No
Secondary	Scores on the Seattle angina questionnaire		4 years	No
Secondary	six-min walk distance (6MWD)	Quality of life as evaluated by 6-min walk distance	4 years	Yes