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