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

Dilated Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01219452
• Other study ID #: MSCKX002
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: October 12, 2010
• Last updated: October 27, 2010
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2010
• Source: Qingdao University
• Contact: Jianxia Hu, MD
• Phone: 86-0532-82911676
• Email: qdyxyhjx[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Biological:
• umbilical cord mesenchymal stem cells
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.

Locations

Country	Name	City	State
China	Stem Cell Research Center of Medical School Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	echocardiography		3 months	No
Secondary	24h HOLTER		2 months	No
Secondary	The level of serum BNP,TNI,HGF?LIF and G/M-CSF		3 months	No
Secondary	The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells		2 months	No