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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dilated Cardiomyopathy

Intervention / Treatment
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* Biological: umbilical cord mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: umbilical cord mesenchymal stem cells<br>intramuscular injection of umbilical cord mesenchymal stem cell | Biological: umbilical cord mesenchymal stem cells<br>* Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.<br>* Other names: mesenchymal stem cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| echocardiography |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24h HOLTER |  | 2 months | 
| The level of serum BNP,TNI,HGF、LIF and G/M-CSF |  | 3 months | 
| The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dilated Cardiomyopathy, Umbilical cord, Mesenchymal stem cells, Children