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

NCT ID: NCT01234181

Last Updated: 2010-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMSCs transplantation

Group Type EXPERIMENTAL

Hypoxia-stressed BMSCs transplantation to cure MI

Intervention Type PROCEDURE

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

No BMSCs transplantation

Group Type SHAM_COMPARATOR

Hypoxia-stressed BMSCs transplantation to cure MI

Intervention Type PROCEDURE

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

Interventions

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Hypoxia-stressed BMSCs transplantation to cure MI

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Principal Investigators

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Jian'an Wang, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine at Zhejiang University

References

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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. doi: 10.1016/j.jtcvs.2007.07.071.

Reference Type BACKGROUND
PMID: 18374759 (View on PubMed)

Hu X, Huang X, Yang Q, Wang L, Sun J, Zhan H, Lin J, Pu Z, Jiang J, Sun Y, Xiang M, Liu X, Xie X, Yu X, Chen Z, Tse HF, Zhang J, Wang J. Safety and efficacy of intracoronary hypoxia-preconditioned bone marrow mononuclear cell administration for acute myocardial infarction patients: The CHINA-AMI randomized controlled trial. Int J Cardiol. 2015 Apr 1;184:446-451. doi: 10.1016/j.ijcard.2015.02.084. Epub 2015 Feb 25.

Reference Type DERIVED
PMID: 25755063 (View on PubMed)

Other Identifiers

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SFDA2010

Identifier Type: REGISTRY

Identifier Source: secondary_id

SAHZJU CT001

Identifier Type: -

Identifier Source: org_study_id