Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy

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Brief Title

Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy

Official Title

Effects of Intramuscular Injection of Umbilical Cord Mesenchymal Stem Cell on the Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy

Brief Summary

      The main aim of the study is to determine whether intramuscular injection of umbilical cord
      mesenchymal stem cells can improve the ventricular function of children with idiopathic
      dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible
      mechanism of the improvement of ventricular function in children with IDCM and 2) to evaluate
      the safety of intramuscular injection of umbilical cord mesenchymal stem cell.
    

Detailed Description

      Children with Idiopathic dilated cardiomyopathy class II to III NYHA with ejection fraction
      over 20% were selected for phase II clinical trial, umbilical cord mesenchymal stem cells
      were injected into limb muscle and followed for 6 months.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

echocardiography

Secondary Outcome

 24h HOLTER

Condition

Dilated Cardiomyopathy

Intervention

umbilical cord mesenchymal stem cells

Study Arms / Comparison Groups

 umbilical cord mesenchymal stem cells
Description:  intramuscular injection of umbilical cord mesenchymal stem cell

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

30

Start Date

October 2010

Completion Date

December 2012

Primary Completion Date

November 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Children of both genders with established clinical and echocardiographic diagnosis of
             dilated cardiomyopathy whose parents accept to participate in the trail.

          -  They should have symptoms and /or signs of heart failure, despite optimized medical
             treatment.

          -  Ejection fraction of left ventricular should be less than 50%, but more than 20%.

        Exclusion Criteria:

          -  associate coronary artery disease.

          -  any history or suspicion of a toxic , pharmacologic or deposit etiology.

          -  associated malignant or pre -malignant systemic disease.

          -  associated hematologic disorder.

          -  a history of sustained ventricular tachycardia or fibrillation.

          -  a history of syncope during the previous year, or with an active infectious disease or
             positive tests to viral disease.
      

Gender

All

Ages

1 Year - 14 Years

Accepts Healthy Volunteers

No

Contacts

zipu li, MD Phd, 86-0532-82911676, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01219452

Organization ID

MSCKX002



Study Sponsor

Qingdao University


Study Sponsor

zipu li, MD Phd, Study Director, The Affiliated Hospital of Medical College of Qingdao University


Verification Date

May 2010