Clincosm LogoSign in Get a demo

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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01234181
Collaborator
(none)
100
Enrollment
2
Arms
25
Duration (Months)

Study Details

Study Description

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
  • Procedure: Hypoxia-stressed BMSCs transplantation to cure MI
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

Primary Outcome Measures

  1. Heart function [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01234181
Other Study ID Numbers:
  • SAHZJU CT001
  • SFDA2010
First Posted:
Nov 4, 2010
Last Update Posted:
Nov 4, 2010
Last Verified:
Nov 1, 2010
Additional relevant MeSH terms:
Myocardial Infarction
Heart Diseases
Infarction
Hypoxia

Study Results

No Results Posted as of Nov 4, 2010