Status:
UNKNOWN
Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy
Lead Sponsor:
Qingdao University
Conditions:
Dilated Cardiomyopathy
Eligibility:
All Genders
1-14 years
Phase:
PHASE1
PHASE2
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 cardiomyopat...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01219452
Start Date
October 1 2010
End Date
December 1 2012
Last Update
October 28 2010
Active Locations (1)
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1
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, China, 266003