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

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ClinicalTrials.gov Identifier: NCT01234181
Recruitment Status : Unknown
Verified November 2010 by Second Affiliated Hospital, School of Medicine, Zhejiang University.
Recruitment status was:  Not yet recruiting
First Posted : November 4, 2010
Last Update Posted : November 4, 2010
Sponsor:
Information provided by:
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI) Procedure: Hypoxia-stressed BMSCs transplantation to cure MI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Intracoronary Transplantation in Myocardial Infarction and Other Heart Diseases.
Study Start Date : November 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BMSCs transplantation Procedure: Hypoxia-stressed BMSCs transplantation to cure MI
Experimental group: intracoronary injection of 10^7 BMSCs Sham Comparator: inject the same volume saline
Sham Comparator: No BMSCs transplantation Procedure: Hypoxia-stressed BMSCs transplantation to cure MI
Experimental group: intracoronary injection of 10^7 BMSCs Sham Comparator: inject the same volume saline


Outcome Measures
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Primary Outcome Measures :
  1. Heart function [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234181


Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Jian'an Wang, M.D, Ph.D 2nd Affiliated Hospital, School of Medicine at Zhejiang University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jian'an Wang / Director, Chief of Heart Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT01234181    
Other Study ID Numbers: SAHZJU CT001
SFDA2010 ( Registry Identifier: State Food and Drug Administration )
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: November 4, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Myocardial Infarction
Heart Diseases
Infarction
Hypoxia
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms, Respiratory