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

NCT01234181 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-11-04

No results posted yet for this study

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.

Conditions

  • Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)

Interventions

PROCEDURE

Hypoxia-stressed BMSCs transplantation to cure MI

Experimental group: intracoronary injection of 10\^7 BMSCs Sham Comparator: inject the same volume saline

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Jian'an Wang, M.D, Ph.D · 2nd Affiliated Hospital, School of Medicine at Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01234181 on ClinicalTrials.gov