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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Second Affiliated Hospital, School of Medicine, Zhejiang University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01234181
First received: November 3, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 3, 2010
November 3, 2010
November 2010
December 2012   (final data collection date for primary outcome measure)
Heart function [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Transplantation to Treat Heart Diseases
Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Intracoronary Transplantation in Myocardial Infarction and Other Heart Diseases.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)
Procedure: Hypoxia-stressed BMSCs transplantation to cure MI
Experimental group: intracoronary injection of 10^7 BMSCs Sham Comparator: inject the same volume saline
  • Experimental: BMSCs transplantation
    Intervention: Procedure: Hypoxia-stressed BMSCs transplantation to cure MI
  • Sham Comparator: No BMSCs transplantation
    Intervention: Procedure: Hypoxia-stressed BMSCs transplantation to cure MI
Hu X, Yu SP, Fraser JL, Lu Z, Ogle ME, Wang JA, Wei L. Transplantation of hypoxia-preconditioned mesenchymal stem cells improves infarcted heart function via enhanced survival of implanted cells and angiogenesis. J Thorac Cardiovasc Surg. 2008 Apr;135(4):799-808.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Not Provided
 
NCT01234181
SAHZJU CT001, SFDA2010
Yes
Jian'an Wang / Director, Chief of Heart Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Not Provided
Principal Investigator: Jian'an Wang, M.D, Ph.D 2nd Affiliated Hospital, School of Medicine at Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP