Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Transplantation to Treat Heart Diseases

Not Applicable

• Conditions: Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)
• Interventions: Procedure: Hypoxia-stressed BMSCs transplantation to cure MI

• Registration Number: NCT01234181
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-11
• Study Start: 2010-11
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Last Update Submitted: 2010-11-03
• Study First Posted: 2010-11-04
• Last Update Posted: 2010-11-04
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of acute Myocardial Infarction(within one month);
• Age under 65;
• Infarction related wall motion abnormality on echocardiography;
• Infarction related TIMI flow grades 3 on coronary angiography during cell injection;
• Informed consent;

Exclusion Criteria

• Active infection, or hematopoietic malignancy;
• Patients have tumor or other lethal diseases;
• Informed refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMSCs transplantation	Hypoxia-stressed BMSCs transplantation to cure MI	-
No BMSCs transplantation	Hypoxia-stressed BMSCs transplantation to cure MI	-

Primary Outcome Measures

Name	Time	Method
Heart function	one year