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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:

Primary Outcome Measures:
  • Heart function [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01234181

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

Publications:
Responsible Party: Jian'an Wang / Director, Chief of Heart Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT01234181     History of Changes
Other Study ID Numbers: SAHZJU CT001, SFDA2010
Study First Received: November 3, 2010
Last Updated: November 3, 2010
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Heart Diseases
Infarction
Myocardial Infarction
Cardiovascular Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014