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

Phase 1

• Conditions: Dilated Cardiomyopathy
• Interventions: Biological: umbilical cord mesenchymal stem cells

• Registration Number: NCT01219452
• Lead Sponsor: Qingdao University

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 Timeline

• Status Verified: 2010-05
• Study Start: 2010-10
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Last Update Submitted: 2010-10-27
• Last Update Posted: 2010-10-28
• Primary Completion: 2012-11
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
umbilical cord mesenchymal stem cells	umbilical cord mesenchymal stem cells	intramuscular injection of umbilical cord mesenchymal stem cell

Primary Outcome Measures

Name	Time	Method
echocardiography	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stem Cell Research Center of Medical School Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China